Laws of the People's Republic of China

No.35

The Measures for the Administration of Drug Registration (for trial implementation) were adopted at the executive meeting of the State Drug Administration on October 15, 2002 and are hereby promulgated. These Measures shall enter into force on December 1, 2002. Director of the Administration Zheng Xiaoyu

October 30, 2002

Measures for the Administration of Drug Registration (for trial implementation) Chapter I Principle Provisions

Article 1

In order to guarantee the safety, effectiveness and controllable quality of drugs, and to regulate the drug registration, these Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), and the Implementation Regulations of the Drug Administration Law of the People's Republic of China (hereinafter referred to as Implementation Regulations).

Article 2

These Measures shall apply to the drug development and clinic study, the application for drug clinic study, drug manufacturing or import, as well as the relevant drug registration, inspection, supervision and administration undertaken within the People's Republic of China.

Article 3

Drug registration shall refer to the examination and approval process by conducting systematic evaluation of the safety, effectiveness and controllability of quality of the drugs to be marketed, and by making the decision on whether or not to approve the drug clinic study, drug manufacturing or import, the process shall include the examination and approval of the contents indicated in the certifications of approval for application for drug alteration and in the attachments thereof.

Article 4

The state encourages the study and development of new drugs, and employs accelerated examination and approval for new drugs developed and new drugs treating complicated and serious diseases.

Article 5

The State Drug Administration (hereinafter referred to as SDA) shall be in charge of the administration of drug registration throughout the country, and be responsible for the examination and approval of drug clinic study, drug manufacturing and import.

The drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government shall, upon the entrustment by the SDA, examine the completeness, normalization and authenticity of the application materials for drug registration.

Article 6

An applicant for drug registration (hereinafter referred to as applicant) shall refer to an institution that files the application for drug registration, bears the corresponding legal liabilities, and holds the certifications of approval for drugs after the application is approved. A domestic applicant shall be an institution with legal person status that legally registered within China, and an overseas applicant shall be a legal overseas drug manufacturer. For an overseas applicant, its work office stationed in China or an agency within China commissioned by it shall make the drug registration for it.

The personnel handling the applications for drug registration shall be the corresponding professionals, and shall be familiar with the laws and regulations on and the technical requirements for the administration of drug registration.

Chapter II Application for Drug Registration

Article 7

Application for drug registration shall include the application for new drugs, application for drugs with existing state standards, application for imported drugs, and the supplementary application thereof. For a domestic applicant, the procedures for application for new drugs and application for drugs with existing state standards shall be followed, for an overseas applicant, the procedures for application for imported drugs shall be followed.

Article 8

Application for new drugs shall refer to the application for registration of drugs that haven't been marketed within China. If the type of preparation or the route of administration of any drugs that have been marketed is changed, the said drugs shall be administered as new drugs.

Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards.

Application for imported drugs shall refer to the application for registration of the drugs that are manufactured overseas and marketed in China.

Supplementary application shall refer to the application for alteration, adding or cancellation of the approved matters or contents after the applications for new drugs, drugs with existing state standards or imported drugs have been approved. If an application for registration of the drugs during the examination and approval or an approved application for clinical study needs to be altered correspondingly, or if transferring the new drug technologies, repackaging the imported drugs, and formalizing the tentative drug standards, the procedures for supplementary application shall be followed.

Article 9

An applicant shall file the application for drug registration with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, and shall submit the relevant materials and drug samples; in case of an application for registration of imported drugs, the applicant shall file the application with the SDA.

Article 10

If two or more entities apply for registration of new drugs as a joint applicant, they shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise is located; if the applicant entities are all drug manufacturing enterprises, they shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise that applies for the preparation is located; if none of the applicant entities are drug manufacturing enterprises, they shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the sample is trial-produced.

Article 11

For the drugs applying for registration or the prescriptions or techniques used, the applicant shall provide the patent in China and explanations on its ownership, submit a guaranty of no infringement upon the patents of others, and promise to be responsible for the possible infringement consequences.

Article 12

Where any dispute arises after the application for drug registration is approved, the parties shall settle the dispute through consultation by themselves, or through judicial bodies or patent administrative bodies pursuant to the relevant laws and regulations.

Article 13

With respect to any drug to which a Chinese patent has been granted, other applicants may file an application for registration within 2 years before the expiration of the patent of that drug. The SDA shall make examination pursuant to these Measures, and, if the provisions are met, approve the manufacturing or import after the patent expires.

Article 14

According to Article 35 of the Implementation Regulations, with respect to the undisclosed experiment data or other data independently obtained and submitted by the manufacturer or seller that has acquired the license for manufacturing or selling drugs containing new chemical compounds, the SDA shall not approve any application for using such undisclosed data without the consent of the licensed applicant within 6 years from the day of approval for the license. But if other applicants submit the data independently obtained by themselves, the SDA may approve them.

When applying for drug registration, other applicants shall promise that all the experiment data are independently obtained by themselves and shall guarantee the authenticity of the data.

Article 15

With respect to the drugs processed in China upon the commission of overseas drug manufacturers, but not sold or used in China, the domestic drug manufacturing enterprise that processes the drug shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located. The drug administration of the province, autonomous region or municipality directly under the Central Government shall approve the application if the provisions are met, but shall not issue the registered number of approval for the drug.

Chapter III Investigational Study of New Drugs before They Are Clinically Used

Article 16

Investigational study of new drugs conducted for application for drug registration shall include the synthetic techniques, extraction methods, physical and chemical properties, purity, choosing of form of this drug, selection of prescriptions, preparation techniques, inspection methods, quality indications and stability, pharmacology, toxicology, nuclein animal dynamics etc. As for Chinese medicine preparations, the sources and processing of the original medicine materials etc shall also be included; as for biologic products, the quality standard, preservation conditions, inheritance stability and immunological study of the initial materials such as microbial and toxic species, cell line or organism etc shall also be included.

Article 17

Relevant administration provisions shall be executed in the Investigational study of new drugs, and the Criterions for the Quality Control of Non-clinical Study of Drugs must be executed in the safety evaluation study.

Article 18

An institution engaging in drug study and development must have the personnel, site, equipment, instruments and management system accommodating to the experiment and study projects; the animals, reagents, and raw materials for experiment use shall meet the relevant provisions and requirements of the state, and the authenticity of all the experiment data and materials shall be guaranteed.

Article 19

For a separate application for the chemical raw material medicines used in the drug preparations and for the Chinese medicine materials and the crude slices of Chinese medicine subject to the administration by the registered number of approval, the registered number of approval for the drug, the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products is required, the raw material medicines must be obtained through legal channels. Where the raw material medicines don't have the registered number of approval, the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products, the approval of the SDA is required.

Article 20

Where an applicant entrusts any other institution to conduct drug study, separate experiment, testing, trial manufacturing or production of samples etc, it shall sign a contract with the trustee. The applicant shall be responsible for the authenticity of the drug study data in the application materials.

Article 21

If the application materials for drug registration include any drug experiment and study materials submitted by any overseas drug study institution, there must be attached explanations produced by that overseas drug study institution on the projects and page numbers of the materials provided, and the certifications which can prove that the institution has been legally registered and notarized overseas, and the attached materials may be used as the application materials only after they have been acknowledged by the SDA. The SDA shall send personnel to make on-spot examinations according to the needs.

Article 22

When inspecting drug study according to the needs, the SDA and the drug administrations of a province, autonomous region or municipality directly under the Central Government may request the applicant or the drug study institution undertaking the experiment to conduct respeated experiment according to the projects, methods and data specified in the application materials, and shall send personnel to examine the experiment on the spot; or an institute for drug control or other drug study institution may be entrusted to make the repeated experiment.

Article 23

Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SDA. Where the applicant adopts other evaluation methods and techniques in the experiment, it shall submit the materials that can prove the scientificity of such methods and techniques.

Chapter IV Clinical Study of Drugs

Section I Basic Requirements

Article 24

Clinical study of drugs includes clinical trial and bioequivalence trial.

Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of Drugs.

Article 25

For the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.

Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards. If clinical study is needed, as for the chemical drugs, the applicant may conduct only the bioequivalence trial; as for Chinese traditional patent medicines and biological products the quality of which needs to be controlled by techniques and standards, the clinical trial shall be conducted.

In supplementary application, it is needed to conduct clinical study if new indications are added for any drug already on the market or if the manufacturing techniques of the drug are altered significantly.

Article 26

Clinical trial is divided into phases I, II, III, and IV. For the application for registration of new drugs, Clinical trial of phases I, II, and III shall be conducted, under certain circumstances, the applicant may only conduct clinical trial of phases II and III or only phase III.

Phase I clinical trial: preliminary trial on clinical pharmacology and human body safety evaluation, which observes the degree of tolerance of human body against the new drug and the drug dynamics, and provides basis for working out the administration scheme.

Phase II clinical trial: preliminary evaluation of the treating effect, the purpose of which is to preliminarily evaluate the treating effect and safety of the drug on the target patient with the applicable disease, and also to provide basis for the determination of study design and dosage administration scheme for phase III clinical trial. Various forms may be employed for the study design of this phase in accordance with the specific study purpose, including randomized controlled clinical trial.

Phase III clinical trial: confirmation phase of the treating effect, the purpose of which is to further verify the treating effect and safety of the drug on the target patient with the applicable disease, to evaluate the relationship between interest and risk, and to eventually provide adequate basis for the application for drug registration for gaining approval. Generally, the trial shall be a randomized controlled trial with sufficient samples.

Phase IV clinical experiment: application study conducted by the applicant independently after the new drug comes into the market, the purpose of which is to examine the curative effect of the drug and the adverse reactions when it is widely used; to evaluate the relationship between interest and risk when the drug is used in ordinary or special groups; and to improve the dosage administration etc.

Article 27

The number of cases experimented in drug clinical study shall be in accordance with the study purpose and meet the relevant statistics requirements and the minimum clinical study case number specified in these Measures. As for rare diseases, special diseases or other circumstances where it is needed to reduce clinical study cases or to exempt the clinical trial, examination and approval by the SDA is required.

Article 28

With respect to bacterins or other special drugs prepared at the phase of seed selection of bacterial or toxic species, if there are no suitable animal models and the laboratories can not evaluate the curative effect thereof, the applicant may apply for clinical study with the SDA on the premise that the safety of the experimented person is secured.

Section II Requirements Before the Study

Article 29

After a drug clinical study has been approved, the applicant shall select, from the institutions qualified for drug clinical trial, an institution to undertake the drug clinical trial, decide on, through consultation, the entity responsible for the clinical study, the major researchers and the entities participating in the clinical study.

Article 30

The applicant shall sign a clinical study contract with the selected entity responsible for and the entities participating in the clinical study, supply the draft of letter of consent with knowledge of the experimented person and the manuals for the researchers conducting the clinical trial, perfect the clinical study scheme by referring to the relevant technical guiding principles, and request the ethic committee of the clinical trial institution to examine the scientificity of the clinical study and the ethic issues involved.

Article 31

The applicant shall provide the selected clinical study entities with free medicines for use in clinical study and drugs for comparison use (except for phase IV clinical trial), enclose the sample inspection report; and bear the expenses needed for the clinical study.

Article 32

Drugs for use in clinical study shall be prepared in workshops meeting the conditions provided for in the Criterions for the Quality Control of Drug Manufacturing. The preparing process shall strictly follow the Criterions for the Quality Control of Drug Manufacturing.

The SDA or the entrusted drug administration of the province, autonomous region or municipality directly under the Central Government may make on-spot examinations according to the needs.

Article 33

An applicant may inspect the drugs for use in clinical study by itself according to the drug standards determined by the SDA, either may it entrust the National Institute for the Control of Pharmaceutical and Biological Products or an institute for drug control designated by the SDA to make the inspection, the drugs can be used in clinical study only after they have passed the inspection. The SDA may designate an institute for drug control to make selective inspection over the drugs for use in the clinical study.

Vaccine products and blood products, and other biological products as well as overseas-manufactured drugs for use in clinical study provided for by the SDA, must be inspected by the institutes for drug control designated by the SDA, and can be used in clinical study only after they have passed the inspection. The applicant shall bear all the responsibilities for the quality of the drugs for clinical study use.

Article 34

An applicant shall, before carrying out the clinical study of drugs, submit the clinical study scheme and the names of the principal researchers of the entity responsible for the clinical study, the list of the participating entities and the researchers thereof, the letter of approval of the ethics committee, the sample of the letter of consent with knowledge to the SDA for record, and shall submit them to the drug administrations of the provinces, autonomous regions or municipalities directly under the Central Government where the clinical study entities are located.

Section III Administration of Clinical Study

Article 35

In the clinical study of drugs, the applicant shall appoint personnel with certain professional knowledge to supervise the implementation of the Criterions for the Quality Control of Clinical Trial of Drugs.

Article 36

If an applicant finds out that any clinical researcher violates the relevant provisions or fails to carry out the clinical study scheme, it shall urge the researcher to correct; if the circumstances are serious, it may demand suspension or termination of the clinical study, and shall report to the SDA and the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.

Article 37

After finishing each phase of clinical trial, the applicant shall submit the clinical study and statistics analysis report to the SDA and to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.

If the period of clinical study exceeds 1 year, the applicant shall submit a report on the clinical study process to the SDA and the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.

Article 38

The clinical study of drugs shall be carried out within 2 years from the day of approval. If it hasn't been carried out within that period, the original certifications of approval shall be invalidated automatically; a new application shall be filed if it is still needed to carry out the clinical study.

Article 39

The entities and personnel participating in the clinical study shall be familiar with the properties, functions, curative effect and safety of the drugs for clinical trial use; understand the responsibilities and obligations of clinical researchers; obtain the letter of consent with knowledge voluntarily signed by the experimented person; and make the clinical study records timely, accurately and truthfully.

Article 40

If an applicant violates the Criterions for the Quality Control of Clinical Trial of Drugs or requests to change the data or conclusion of the trial, the entities and personnel participating in the clinical study shall report to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government and the SDA.

Article 41

The entities undertaking the clinical study and the clinical researchers are obliged to take necessary measures to guarantee the safety of the experimented person.

Clinical researchers shall pay close attention to the occurrence of any adverse reaction case involving the drugs for clinical study use, take proper treating measures for the experimented person without delay, and write the case into the records.

If any serious adverse reaction case occurs in the course of a clinical study, the researchers shall, within 24 hours, report to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government and the SDA, and shall make a timely report to the ethics committee.

Article 42

For the clinical studies that have been approved, the SDA and the drug administrations of the relevant provinces, autonomous regions and municipalities directly under the Central Government shall conduct regular or specific on-spot examinations or data checks.

Article 43

If any of the following cases occurs in the course of a clinical study, the SDA may request the applicant to modify the clinical study scheme, or to suspend or terminate the clinical study:

(1)

The ethics committee fails to perform its duties;

(2)

Safety of the experimented person can't be effectively guaranteed;

(3)

A serious adverse reaction case hasn't been reported within the prescribed time limit;

(4)

Report on the clinical study progress is not submitted in timely and truthfully;

(5)

Approved clinical study fails to acquire evaluable results within 2 years after the scheduled end of the study;

(6)

There is, already, evidence proving that the drugs for clinical trial use are ineffective;

(7)

Drugs for clinical trial use encounter quality problems;

(8)

Frauds are committed in the clinical study;

(9)

Other cases of violation of the Criterions for the Quality Control of Clinical Trial of Drugs.

Article 44

Where the SDA makes the decision of modifying the clinical study scheme, ordering suspension or termination of the clinical study, the applicant or the entity conducting the clinical study shall execute such decision. If they have any objections, they may present their opinions within 10 days and explain the reasons in written form.

Article 45

If large-scope and unanticipated adverse reactions or serious adverse reaction cases occur in a clinical study, or there has been evidence that can prove the drugs for clinical trial use have serious quality problems, the SDA or the drug administration of the relevant province, autonomous region or municipality directly under the Central Government may take urgent measures and order suspension or termination of the clinical study, the applicant and the clinical study entity must stop the clinical study immediately.

Article 46

The use of drugs for clinical trial use shall be taken care of by the clinical researchers. The researches must guarantee that all the drugs for study use are only used on the experimented persons, and the method of use and dosage shall conform to the study scheme. The researchers may not pass the drugs for study use to any person not participating in the clinical study. Drugs for clinical study use may not be marketed.

Article 47

If an overseas applicant wishes to conduct an international multi-center clinical study of drugs, it shall file an application with the SDA pursuant to these Measures and meet the requirements of the following provisions:

(1)

The drugs for clinical study use shall be drugs that have been registered overseas or have entered Phase II clinical trial; the SDA will not accept any application filed by an overseas applicant for international multi-center clinical study of new preventive vaccine drugs not yet registered overseas;

(2)

The SDA may, when granting approval for the conduction of international multi-center clinical study of drugs, request the applicant to carry out Phase I clinical trial in China according to the needs;

(3)

In the conduction of international multi-center clinical study of drugs in China, if serious adverse reactions and unanticipated adverse reactions relating to such drugs are found in any country, the applicant shall report to the SDA timely pursuant to the relevant provisions;

(4)

After a clinical study is ended, the applicant shall submit the complete clinical study report to the SDA;

(5)

Where the data obtained in an international multi-center clinical study of drugs are used in the application for drug registration in China, the provisions relating to clinical study provided for in the Drug Administration Law, the Implementation Regulations, and these Measures must be met, and the applicant must submit all the study materials of the international multi-center clinical study.

Chapter V Application and Examination & Approval of New Drugs

Section I Basic Requirements

Article 48

The materials submitted for the application for registration of new drugs shall be complete and normative, and the data must be true and reliable; the documentary materials quoted shall be marked with the title of the work, title of the publication, as well as the volume, issue and page etc; the documentary materials not publicly published shall be accompanied with the certifications of permission of use by the owner of the materials. Materials in foreign languages shall be accompanied with Chinese translations pursuant to the requirements.

Article 49

The SDA shall make an accelerated examination and approval with respect to the applications for the following new drugs:

(1)

New Chinese medicine materials, effective components extracted from Chinese medicines or natural drugs, as well as the preparations of those components;

(2)

Chemical raw materials medicines, as well as the preparations and biological products thereof, that haven't been approved to be marketed home and abroad;

(3)

New drugs that fight against AIDS virus and that are used in the diagnosis and prevention of AIDS, new drugs treating malignant tumours and rare diseases etc;

(4)

New drugs treating the diseases that can't be cured by effective means yet.

Article 50

The drug administration of a province, autonomous region and municipality directly under the Central Government shall, after receiving an application for registration of any new drug listed in Article 49 of these Measures, make the examination and give opinions on whether that application meets the conditions for accelerated examination and approval. The SDA shall determine whether to make an accelerated examination and approval for that application for new drug upon the acceptance of it.

Article 51

With respect to any new drug jointly developed by several entities, the application for registration may be filed by one entity among them, and the other entities may not file the application any more. Except the drugs listed in Subparagraphs 1) and 2) of Article 49 of these Measures, after the application for a new drug is approved, each category of such drug may only be manufactured by one entity, and different specs of the same category may not be manufactured by different entities.

Article 52

In the examination process of a new drug, if the technical requirements for that new drug are changed because the same category of drug is allowed to go on the market overseas, the original technical requirements shall remain unchanged.

Section II Examination & Approval of Clinical Study of New Drugs

Article 53

After finishing the investigational study of new drugs, an applicant shall fill in the Application Form for Drug Registration, and faithfully submit the relevant materials and drug samples to the drug administrations of the province, autonomous region or municipality directly under the Central Government.

Article 54

The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials, organize an on-spot investigation of the manufacturing process and conditions, select samples for inspection use, and send notice on registration inspection to the designated institute for drug control. The administration shall, after finishing the aforesaid work, submit the examination opinions, investigation report and application materials to the SDA, and notify the applicant.

Article 55

The institute for drug control receiving the notice on registration inspection shall make an inspection on the selected samples, check the drug standards of the application, and submit the inspection report and check opinions to the SDA within the prescribed time limit, and shall send those documents to the drug administration of the province, autonomous region or municipality directly under the Central Government that sent the notice on inspection and to the applicant.

Article 56

With respect to the application materials for clinical study of new drugs submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, the SDA shall accept the application if the requirements are met after examination, issue the notice on acceptance, and may request the applicant to supply drug samples if necessary.

Article 57

After accepting an application for new drugs, the SDA shall organize professionals in pharmacology, medicine and other technical fields to make the technical evaluation of the new drugs, and decide on whether or not to approve the clinical study of such drugs by the form of Official Letter on Clinical Study of Drugs.

Article 58

If the institute for drug control deems that the drug standard supplied can't control the quality, the applicant may withdraw its application for new drugs. If the application is not withdrawn, the SDA may return such application if it is determined that the drug standard can't control the quality after examination.

Article 59

If it does not accord with its medicines standard declared that the sample is examined, the SDA may return the drug's application after examination.

Article 60

If a withdrawn application for new drugs meets the conditions for application after the applicant makes study over again, it may be filed again and be processed pursuant to the original application procedures.

Article 61

During the examination of an application for drug registration by the SDA, no new technical materials may be supplemented except for innovative drug components or new discoveries involving the safety of drugs. If it is a must to supplement new technical materials, the applicant shall withdraw its application for drug registration and file a new one pursuant to the original procedures.

Section III Examination & Approval of Manufacture of New Drugs

Article 62

After finishing the clinical study of drugs, an applicant shall submit the clinical study materials and other modified and supplemented materials to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, explain the basis and reasons in details, and send the raw materials of the standard products to the National Institute for the Control of Pharmaceutical and Biological Products at the same time.

Article 63

The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials; organize an on-spot investigation of the manufacturing process and conditions; select samples from products of 3 successive batch numbers, and send notice on registration inspection to the designated institute for drug control; submit the examination opinions, investigation report and application materials to the SDA within the prescribed time limit, and notify the applicant.

Article 64

The 3 batches of samples needed for application for new drugs shall be manufactured in the workshops with the certificate of Criterions for the Quality Control of Drug Manufacturing; for newly initiated drug manufacturing enterprises, newly established drug manufacturing workshops of drug manufacturing enterprises, or newly added form of preparations to be manufactured, the manufacturing process of samples thereof must conform to the requirements of the Criterions for the Quality Control of Drug Manufacturing.

Article 65

An institute for drug control receiving the notice on registration inspection shall make an inspection over the selected samples, and submit the inspection report to the SDA within the prescribed time limit, and at the same time send a copy to the drug administration of the province, autonomous region or municipality directly under the Central Government where the inspection is conducted, and to the applicant.

Article 66

With respect to the materials submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, the SDA shall accept the application if the requirements are met after examination, and issue the notice on acceptance.

Article 67

The SDA shall make an overall review of the materials submitted, and decide on whether to approve or not by the form of Official Document on Drug Registration. New drug certificate shall be issued if the requirements of the provisions are met; and the registered number of approval for drugs shall at the same time be issued if the applicant possesses the License for Drug Manufacturing and the corresponding conditions for manufacturing of that drug.

Article 68

When approving an application for new drug, the SDA shall at the same time promulgate the registration standard and specifications of that drug.

Drug specifications shall be verified by the SDA according to the application materials submitted by the applicant. A drug manufacturing enterprise shall be responsible for the correctness and accuracy of the drug specifications, follow up the safety and effectiveness of the drug after it goes on the market, and shall file an application for modifying the drug specifications without delay if necessary.

Drug specifications shall be printed pursuant to the provisions of the SDA.

Article 69

Where the 3 batches of drugs manufactured for the application for new drugs were manufactured in the workshops with the License for Drug Manufacturing and the Criterions for the Quality Control of Drug Manufacturing, those drugs may be marketed within their effective periods after passing the inspection conducted by the institute for drug control designated by the SDA and obtaining the registered number of approval for drugs.

Section IV Administration of the Monitoring Periods of New Drugs

Article 70

With a view to protecting the public health, the SDA may set forth monitoring periods for new drugs approved to be manufactured, to continually monitor the safety of those new drugs.

The SDA will not approve other enterprises to manufacture or import new drugs within the monitoring periods.

Article 71

The monitoring period of a new drug shall be calculated starting from the day of approval for manufacturing of that new drug, and may not exceed 5 years. With respect to different new drugs, different monitoring periods shall be determined according to the existing safety study materials and domestic and overseas study process concerning such drugs.

Article 72

Where a new drug enters the monitoring period, the SDA will no longer accept any application for new drug of the same category filed by any other applicant. The drug administration of the province, autonomous region or municipality directly under the Central Government shall return the other applications already received to the applicants.

Article 73

For a new drug within the monitoring period, the drug manufacturing enterprise shall regularly inspect the manufacturing techniques, quality, stability, curative effect and adverse reactions etc, and report each year to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

Where the entities relating to the manufacturing, operation, use, or inspection or supervision of drugs find out that the new drug has serious quality problems, or causes serious or unanticipated adverse reactions, they must report without delay to the drug administration of the province, autonomous region or municipality directly under the Central Government.

Article 74

With respect to the new drug with serious quality problems, or causing serious or unanticipated adverse reactions, the drug administrations of the province, autonomous region or municipality directly under the Central Government shall organize investigation immediately and report to the SDA.

Article 75

If a drug manufacturing enterprise don't fulfil responsibility of a new drug during the monitoring period in accordance with provisions, the drug administration of the province, autonomous region or municipality directly under the Central Government should order it to correct.

Article 76

If a new drug for which the monitoring period has been set has not been manufactured within 2 years from the day of approval, the SDA may approve the applications for manufacturing that new drug filed by other drug manufacturing enterprises, and continue the monitoring.

Article 77

Where the SDA has already approved any other applicant to conduct clinical study of drugs before a new drug enters the monitoring period, such application may continue to be processed pursuant to the procedures for application and examination and approval of drug registration; the SDA may approve the manufacturing or importing of the drug if it meets the requirements of the provisions, and monitor it together with such new drug manufactured by domestic drug manufacturing enterprises.

Article 78

Where the SDA has already accepted but not yet approved any other applicant to conduct clinical study of drugs before a new drug enters the monitoring period, such application shall be returned; after the monitoring period of such new drug ends, the applicant may file an application for registration of drugs with existing state standards.

Article 79

If an imported drug has been approved to be registered and marketed before any domestic applicant is approved to conduct clinical study, the application may continue to be processed pursuant to the procedures for application and examination and approval of drug registration; the SDA may approve the manufacturing of the drug if the requirements are met; and the applicant may also withdraw that application and file a new application for registration of drugs with existing state standards. If the application for clinical study filed by any other applicant has been accepted but not yet approved, such application shall be returned; a new application shall be filed pursuant to the requirements for registration of drugs with existing state standards.

Chapter VI Application and Examination & Approval of Drugs with Existing State Standards

Article 80

To apply for the manufacturing of drugs with existing state standards, the applicant shall be a drug manufacturing enterprise with the License for Drug Manufacturing and with the certificate of Criterions for the Quality Control of Drug Manufacturing. The drug for which the application is filed shall fall within the manufacturing scope specified in the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing.

Article 81

If the certificate of Criterions for the Quality Control of Drug Manufacturing hasn't been obtained for a newly initiated drug manufacturing enterprise, for a newly established drug manufacturing workshop of a drug manufacturing enterprise, or for the adding of new form of preparations to be manufactured, the said certificate shall be obtained within the time limit provided for in Article 6 of the Implementation Regulations; if the certificate is not obtained within that period, the registered number of approval for drugs shall be invalidated automatically, and shall be written off by the SDA.

Article 82

An applicant shall finish the trial manufacturing pursuant to the relevant technical requirements, fill out the Application Form for Drug Registration, and submit the relevant materials and drug samples to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

Article 83

The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials, accept the application if the requirements are met, and issue the notice on acceptance; organize an on-spot inspection of the manufacturing process and conditions, select samples from the products of 3 successive batch numbers, notify the designated institutes for drug control to inspect the samples; and submit the examination opinions and application materials to the SDA within the prescribed time limit, and notify the applicant.

Article 84

An institute for drug control receiving the notice on registration inspection shall make an inspection on the selected samples, and send the inspection report to the SDA within the prescribed time limit, and at the same time send a copy to the drug administration of the province, autonomous region or municipality directly under the Central Government, which notified it to make the inspection, and to the applicant.

Article 85

The SDA shall make a comprehensive evaluation of the materials submitted, and issue the Official Letter on Clinical Study of Drugs if clinical study is needed.

After finishing the clinical study, the applicant shall submit the clinical study materials to the SDA.

Article 86

The SDA determines to approve producing at form on the Official Letter on Clinical Study of Drugs. The one which accords with the provisions is issued the registered number of approval for drugs.

Article 87

The SDA and the drug administration of the province, autonomous region or municipality directly under the Central Government will not accept any application filed on the basis of tentative standards for registration of drugs with existing state standards.

Article 88

With respect to an application for registration of drugs with existing state standards which need further evaluation of curative effect and safety, the SDA may suspend the acceptance and examination & approval.

Article 89

If the 3 batches of drugs manufactured for the application for the registered number of approval for drugs were manufactured in workshops with the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing, those drugs may be marketed within their effective periods after passing the inspection conducted by the institute for drug control designated by the SDA and obtaining the registered number of approval for drugs.

Chapter VII Application and Examination & Approval of Imported Drugs

Article 90

For the application for import of drugs, permission for marketing by the country or region where the overseas drug manufacturer is located must be obtained; if no permission for marketing has been obtained, but the SDA confirms that the said drugs are safe, effective and needed for clinical use, the import thereof may be approved.

The drug of which import is applied for shall meet the criterions on quality control of drug manufacturing of the country or region where it is manufactured and the requirements of the Criterions for the Quality Control of Drug Manufacturing of China.

Article 91

To apply for the registration of imported drugs, an applicant shall fill in the Application Form for Drug Registration, submit the relevant materials and samples, supply the relevant certifications and file the application with the SDA.

Article 92

The SDA shall make an examination of form of the submitted materials, accept the application if the requirements are met, issue the notice on acceptance and notify the National Institute for the Control of Pharmaceutical and Biological Products to conduct drug registration inspection.

The SDA shall, according to the needs, make on-spot investigations of the developing process and manufacturing conditions.

Article 93

After finishing the registration inspection of the imported drug, the National Institute for the Control of Pharmaceutical and Biological Products shall submit the reviewed drug standard, inspection report and review opinions to the SDA.

Article 94

The SDA shall organize a comprehensive evaluation of the submitted materials, and decide on whether or not to approve the clinical study by the form of Official Letter on Drug Clinical Study.

Article 95

After the clinical study has been approved, the applicant shall carry it out pursuant to Chapter 4 of these Measures and the relevant requirements.

After the clinical study is ended, the applicant shall submit the clinical study materials, samples and other modified and supplemented materials pursuant to the provisions, explain the basis and reasons in details, and supply the relevant certifications.

Article 96

The SDA shall make a comprehensive evaluation of the clinical study materials etc submitted, and issue the Registration Certificate of Imported Drugs if the requirements are met. The Registration Certificate of Pharmaceutical Products shall be issued if the drug is registered by a drug manufacturer of Hong Kong, Macao or Taiwan areas of China.

Article 97

For the application for importing drug preparations, certifications of legal sources of the packaging materials and containers directly contacting the drugs, and certifications of legal sources of the raw material medicines and supplementary materials used to manufacture those preparations must be provided. If the raw material medicines and supplementary materials haven't been approved by the SDA, the study materials relating to the manufacturing techniques, quality indications and inspection methods shall be submitted.

Article 98

When approving the import of the drug, the SDA shall at the same time promulgate the ratified registration standard and specifications of the imported drugs.

Chapter VIII Application and Examination & Approval of Nonprescription Drugs

Article 99

Nonprescription drugs shall refer to the drugs promulgated by the SDA that the customers may judge, purchase and use by themselves without the prescriptions given by practicing physicians and practicing assistant physicians.

Article 100

If the drug applying for registration is in any of the following cases, it may apply for being nonprescription drug at the same time:

(1)

Manufacturing or import of a nonprescription drug with existing state drug standard;

(2)

Being a drug of a changed form of preparations of a nonprescription drug determined by the SDA, but with the same applicable diseases, dosage administration and route of administration;

(3)

Being a new compound preparation composed of the activated components of nonprescription drugs determined by the SDA.

Article 101

For a drug registration application that meets the requirements of the relevant provisions of the state on nonprescription drugs, the SDA shall determine the drug as nonprescription drug when approving the manufacturing or import of that drug.

A drug that can't apply for registration as nonprescription drug may only apply for conversion into nonprescription drug after wide range of clinical application.

Article 102

Manufacturing and import of nonprescription drugs with existing state drug standards shall be dealt with pursuant to Chapter 6 and Chapter 7 of these Measures.

Article 103

If the form of preparations of any nonprescription drug has been changed without changing the route of administration, and the changed form of preparations meet the requirements for nonprescription drugs, generally, no clinical trial is required, however, bioequivalence trial shall be conducted with respect to solid preparations for oral use.

Article 104

With respect to the new compound preparations composed of the activated components of nonprescription drugs determined by the SDA, the prescription basis shall be specified, and clinical trial shall be conducted if necessary.

Article 105

The languages used in the specifications of nonprescription drugs shall be scientific and understandable to facilitate the customers to judge, choose and use those drugs by themselves, and must be ratified by the SDA. The packaging of nonprescription drugs must bear the special marks for nonprescription drugs prescribed by the SDA.

Article 106

Where any nonprescription drug approved by the SDA has been found unsuitable for being nonprescription drug during the use, the SDA may change it into prescription drug.

Chapter IX Supplementary Drug Application and Examination & Approval Thereof

Article 107

If the approval certifications of a drug as well as the drug standard, drug specifications and matters indicated in the labels attached are changed, and the change of manufacturing techniques has affected the drug quality, the applicant shall file a supplementary application.

Article 108

An applicant filing the supplementary application shall be the holder of the approval certifications of the drug or the applicant for drug registration.

Article 109

The applicant shall fill in the Supplementary Drug Application Form, and submit the relevant materials and explanations to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located. If any change of ownership of the drug is involved, valid certifications shall be provided.

For a supplementary application concerning any imported drug, the applicant shall submit the relevant materials and explanations to the SDA, and present the documents of approval for the change by the drug authorities of the country or region where the drug is manufactured.

Article 110

With respect to a supplementary application for adding applicable diseases or functions of the drugs, modifying the drug standard or altering the supplementary materials etc, the drug administration of a province, autonomous region or municipality directly under the Central Government shall give the examination opinions and submit the application to the SDA for examination and approval, and notify the applicant.

With respect to a supplementary application for changing the drug packaging specs, altering the enterprise name or modifying the drug standard and specifications pursuant to the requirements of the SDA, the drug administration of a province, autonomous region or municipality directly under the Central Government shall make the examination and approval, submit the application to the SDA for record and notify the applicant.

Article 111

If the SDA doesn't raise any objections within 20 days from receiving the documents for record, the drug administration of a province, autonomous region or municipality directly under the Central Government may notify the applicant to execute that supplementary application.

Article 112

With respect to a supplementary application concerning any imported drug, the SDA shall make the examination and approval. For a supplementary application concerning an imported drug of which the examination and approval are conducted on a record basis, if the SDA doesn't raise any objections within 30 days since the acceptance, the applicant may execute that supplementary application.

Article 113

With respect to a supplementary application concerning application for registered number of approval for drugs, change of drug manufacturing address or change of manufacturing techniques etc on the basis of a new drug certificate, the drug administration of a province, autonomous region or municipality directly under the Central Government shall organize investigations of the trial spot, select samples for inspection use, and notify the designated institute for drug control to make an inspection over the samples.

With respect to a supplementary application for modifying the drug standard, the institutes for drug control shall review the standard if necessary.

Article 114

The SDA shall examine the supplementary drug application and decide whether to approval or not by the form of Official Document on Drug Supplementary Applications. If it is needed to replace the drug approval certifications, the original ones shall be written off; if it is needed to issue new drug approval certifications, the original ones shall remain valid.

Article 115

The valid term of the approval certifications for a supplementary drug application shall be identical with that of the original approval certifications, and a new application for registration shall be filed upon the expiration.

Chapter X Re-registration of Drugs

Article 116

Re-registration of drugs shall refer to the examination and approval conducted on the drugs continuing to be manufactured and imported after the valid term of the drug approval certifications expires.

Article 117

The valid term of the registered number of approval for drugs, Registration Certificate of Imported Drugs or Registration Certificate of Pharmaceutical Products issued by the SDA is 5 years. If the manufacturing or import needs to continue after the expiration of the valid term, the applicant shall apply for re-registration within 6 months before the expiration.

Article 118

A drug manufacturing enterprise with the registered number of approval for drugs shall file the application for re-registration of drugs with the drug administration of the province, autonomous region or municipality directly under the Central Government, fill in the Application Form for Re-registration of Drugs and supply the relevant application materials.

An application for re-registration of imported drugs shall be filed by the applicant with the SDA.

Article 119

The drug administration of the province, autonomous region or municipality directly under the Central Government shall, upon the entrustment by the SDA, finish the examination of the application for drug re-registration within 50 days and submit it to the SDA for record.

Article 120

If the SDA doesn't issue the notice on not granting the re-registration within 50 days from receiving the record materials, the drug administration of the province, autonomous region or municipality directly under the Central Government shall re-register the drugs.

Article 121

The SDA shall finish the examination within 100 days from accepting an application for re-registration of imported drugs. And the re-registration shall be made if the application meets the requirements of the provisions.

Article 122

In any of the following situations, the drug shall not be re-registered:

(1)

Failure to file the application for re-registration within the prescribed period;

(2)

Failure to meet the relevant requirements set forth by the SDA for approval for marketing;

(3)

Failure to finish Phase IV clinical trial pursuant to the requirements;

(4)

Failure to monitor the drug adverse reactions pursuant to the provisions;

(5)

The drug falls within a category to be eliminated as re-evaluated by the SDA;

(6)

The drug approval certifications should be revoked pursuant to the Drug Administration Law;

(7)

Failure to possess the manufacturing conditions provided for in the Drug Administration Law;

(8)

Failure to perform the responsibilities of monitoring period;

(9)

Other non-compliance with the relevant provisions.

Article 123

If the provisions on re-registration of drugs are not met, the SDA shall issue a notice on not granting the re-registration, and write off the registered number of approval for drugs, Registration Certificate for Imported Drugs or Registration Certificate for Pharmaceutical Products.

Chapter XI Transfer of New Drug Technologies

Article 124

Transfer of new drug technologies shall refer to the act of the holder of the certificate of a new drug to transfer the manufacturing technologies of the new drug to a drug manufacturing enterprise, with the latter applying for the manufacturing of that new drug.

Article 125

Transferor of new drug technologies shall refer to an agency that holds the new drug certificate but hasn't yet obtained the registered number of approval for drugs; if the registered number of approval for drugs has been obtained, the applicant shall file an application for writing off the original registered number of approval for drugs when applying for transfer of new drug technologies.

Article 126

New drug technologies shall be transferred to a drug manufacturing enterprise once off. If the said drug manufacturing enterprise can't manufacture the drug due to special reasons, the holder of the new drug certificate may transfer the new drug technologies for a second time on the basis of the relevant certifications, such as the contract by which the original transferee abandons the manufacturing of that new drug etc. The SDA shall write off the registered number of approval for drugs of the said category of the original transferee pursuant to the provisions.

The enterprise accepting the new drug technologies transferred may not transfer such technologies for a second time.

Article 127

A drug manufacturing enterprise accepting the transferred new drug technologies must obtain the License for Drug Manufacturing and the certificate of the Criterions for the Quality Control of Drug Manufacturing. The new drug transferred shall fall within the manufacturing scope specified in the License for Drug Manufacturing and the certificate of the Criterions for the Quality Control of Drug Manufacturing of the transferee.

Article 128

When transferring the new drug manufacturing technologies, the holder of the new drug certificate shall sign a transfer contract with the transferee, and shall transfer all the technologies and materials to the transferee and direct the latter to manufacture, on a trial basis, 3 successive batches of qualified products.

Article 129

With respect to a new drug jointly developed by several entities, the transfer of new drug technologies shall be proposed by the entities that jointly signed on the new drug certificate and a transfer contract shall be concluded.

Article 130

When transferring the new drug technologies, the holder of the new drug certificate and the transferee shall jointly file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the transferee is located, fill in the Supplementary Drug Application Form, and submit the relevant materials and enclose the transfer contract.

Article 131

After accepting an application for the transfer of new drug technologies, the drug administration of the province, autonomous region or municipality directly under the Central Government shall investigate the spot of trial manufacturing, manufacturing equipment, manufacturing of samples and inspection records of the transferee, select samples and notify the institute for drug control to make an inspection.

Article 132

The institute for drug control undertaking the drug inspection shall finish the inspection within the prescribed time limit, produce the inspection report and submit it to the drug administration of the province, autonomous region or municipality directly under the Central Government which notified it to make the inspection.

Article 133

The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of the inspection report and relevant materials received and give opinions thereon, submit them to the SDA and notify the applicant of the examination opinions.

Article 134

The SDA shall make a comprehensive evaluation of the transfer of new drug technologies. If clinical study is needed, the Official Document on Clinical Study of Drugs shall be issued.

The applicant shall, after finishing the clinical study, submit the clinical study materials to the SDA.

Article 135

The SDA shall decide whether or not to approve the manufacturing by the form of Official Document on Supplementary Drug Applications. Drug approval certificate shall be issued if the requirements of the provisions are met, and the drug approval certificate already obtained by the transferor shall be written off.

Article 136

With respect to a drug within its monitoring period, the new drug technologies may not be transferred.

Chapter XII Application and Examination & Approval of Repackaging of Imported Drugs

Article 137

Repackaging of imported drugs shall refer to changing big drug packages into small ones after the final preparations are finished overseas, or making external packaging, placing specifications and affixing labels etc for drugs of which the internal packaging has been finished.

Article 138

The following requirements shall be met for the application for repackaging of imported drugs:

(1)

The drug applying for repackaging has already obtained the Registration Certificate of Imported Drugs or the Registration License for Pharmaceutical Products;

(2)

The drug shall fall within a category that has not yet been manufactured within China, or a category of which the manufacturing within China can't meet the clinical needs;

(3)

The same category manufactured by the same drug manufacturer shall be repackaged by one drug manufacturing enterprise, and the period shall not exceed 5 years generally.

Article 139

An overseas drug manufacturer shall sign a contract on repackaging of imported drugs with the domestic drug manufacturing enterprise, and fill in the Supplementary Drug Application Form.

Article 140

A drug manufacturing enterprise accepting the repackaging work must hold the License for Drug Manufacturing and have the certificate of Criterions for the Quality Control of Drug Manufacturing; the drug to be repackaged shall fall within the manufacturing scope specified in the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing of the trustee.

Article 141

The trustee shall file the application for drug repackaging with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, submit the Supplementary Drug Application Form filled in by the trustor, and submit the relevant materials, samples and the trust contract etc. The drug administration of the province, autonomous region or municipality directly under the Central Government shall finish the examination within the prescribed time limit and submit the application materials to the SDA.

Article 142

The SDA shall examine the submitted materials and decide on whether to approve the repackaging by the form of Official Document on Supplementary Drug Applications. If the requirements of the provisions are met, the application shall be approved and the registered number of approval for drugs shall be issued.

Article 143

An application for drug repackaging shall be filed 1 year earlier than the expiration of the valid term of the Registration Certificate of Imported Drugs or Registration Certificate of Pharmaceutical Products of the drug.

Article 144

Registration standards for imported drugs shall be implemented for the drugs to be repackaged.

Article 145

The packaging, labels, and specifications of the drugs repackaged must meet the requirements of the relevant provisions of the SDA, and at the same time the registered number of approval for drug repackaging and the registration certificate number of imported drugs or registration certificate number of pharmaceutical products shall also be indicated.

Article 146

The import inspection of overseas preparations in large packages shall follow the relevant provisions of the SDA. The same drug standard shall be implemented in the inspection of repackaged products and the import inspection. The first 3 batches of products repackaged shall be sent to the institute for drug control designated by the SDA, and shall pass the inspection before they can be marketed.

Article 147

The overseas drug manufacturer supplying the drugs shall be responsible for the quality of the repackaged drugs, if any quality problem arises, the SDA may cancel the registered number of approval of the repackaged drugs, and may cancel the Registration Certificate of Imported Drugs or Registration Certificate of Pharmaceutical Products according to the provisions of Article 42 of the Drug Administration Law.

Article 148

If the drugs are packaged within China upon the entrustment by overseas drug manufacturers and by adopting the preparations and packaging materials provided thereby, but not marketed or used within China, the domestic drug manufacturing enterprise making the packaging shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, it may package the drugs only after being approved, and it shall put that on record with the SDA, but the registered number of approval for drugs shall not be issued.

Chapter XIII Administration of Drug Registration Inspection

Article 149

Drug registration inspection must be conducted in the application for drug registration. Drug registration inspection shall include sample inspection and drug standard review conducted on the drugs applying for registration.

Sample inspection shall refer to the inspection conducted by the institute for drug control on the samples pursuant to the drug standard supplied by the applicant.

Drug standard review shall refer to the lab inspection and examination conducted by the institute for drug control with respect to the feasibility, scientificity of the inspection methods specified in the drug standard supplied and whether the indications set by the standard can control the drug quality etc.

Article 150

Drug registration inspection shall be undertaken by an institute for drug control of the province, autonomous region or municipality directly under the Central Government. Registration inspection of imported drugs shall be carried out by the National Institute for the Control of Pharmaceutical and Biological Products.

Article 151

Registration inspection of the following drugs shall be undertaken by the National Institute for the Control of Pharmaceutical and Biological Products or an institute for drug control designated by it:

(1)

Drugs listed in Subparagraphs 1) and 2) of Article 49 of these Measures;

(2)

Biological products;

(3)

Other drugs provided for by the SDA.

Article 152

For drugs meeting the provisions of Article 49 of these Measures, the institute for drug control shall give priority to them in the arrangement of inspection and drug standard review.

Article 153

An institute undertaking the drug registration inspection shall, pursuant to the requirements of the Criterions on the Administration of Quality Control of the Laboratories of Institutes for Drug Control and the requirements of national metrological authentication, have the personnel and equipment accommodating to the tasks of drug registration inspection, thus to meet the quality guarantee system and technical requirements of drug registration inspection.

Article 154

The applicant shall provide the institute for drug control with the relevant materials needed, submit the samples or assist it in the selecting of samples for inspection use, and provide the standard materials for inspection use. Quantity of the samples shall be 3 times of that used in the inspection, and the manufacturing check records of the corresponding batches shall also be included with respect to biological products.

Article 155

With respect to an application for manufacturing of the drug with existing state standard, the institute for drug control shall, upon receipt of the samples, make the inspection pursuant to the state standard, and make a comprehensive analysis of the change of quality indications resulted from the change of techniques, and shall ask the applicant to work out the corresponding quality indications if necessary to ensure the controllability of the drug quality.

Article 156

With respect to the review of standard for a new drug, the institute for drug control shall, apart from making inspection over the samples, give review opinions on the drug standard, inspection items and methods for the inspected drug pursuant to the study data of the drug, the drug standards for drugs of the same category home and abroad and the relevant requirements of the state.

The institute shall inform the applicant, if necessary, before giving the review opinions. If the applicant has any objections, it shall present its complaint to the institute within 10 days. If the institute disagrees with the complaint of the applicant, it shall submit its review opinions and the applicant's complaint to the SDA together, and shall send a copy to the applicant and the drug administration of the province, autonomous region or municipality directly under the Central Government which sent the notice on drug registration inspection.

Article 157

With respect to the reformulation of a drug standard, the applicant may not entrust the institute for drug control that gave the opinions to carry out the study of the drug; neither may that institute accept such an entrustment.

Chapter XIV Administration of the Drug Registration Standards

Section I Basic Requirements

Article 158

State drug standards shall refer to the technical requirements for quality indications, inspection methods and manufacturing techniques etc set forth by the state in order to guarantee the drug quality, including the Drug Code of the People's Republic of China, the drug registration standards and other drug standards promulgated by the SDA.

Drug registration standards shall refer to the standards by which the SDA approve certain drugs to the applicant, and which the drug manufacturing enterprises of the said drugs must carry out.

Article 159

The items of a drug registration standard and the setting of the inspection methods thereof shall conform to the technical guiding principles and the principles and detailed rules for drawing up the state drug standards promulgated by the SDA.

Article 160

The applicant shall, on the premise that the quality of the raw materials and the manufacturing techniques are steady, select the representative samples to conduct the study of a standard.

Section II Formalization of Tentative Drug Standards

Article 161

After the manufacturing of a new drug has been approved, the drug standard thereof shall be a tentative standard, and the tentative period shall be 2 years. For other drugs, if further investigation shall be carried out over the manufacturing techniques and the stability of the product quality after the manufacturing has been approved, the drug standards thereof may also be approved as tentative standards.

Article 162

In the manufacturing of a drug with tentative standard, the drug manufacturing enterprise shall, 3 months before the expiration of the tentative period, file an application of formalization of the standard with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located pursuant to the requirements for supplementary application, and shall submit the quality assessment materials of the drug within the tentative period of the standard, as well as the opinions on revision of the tentative standard.

Article 163

The drug administration of the province, autonomous region or municipality directly under the Central Government shall finish the examination within 10 days from receiving the application for formalization of the tentative drug standard, and shall submit the examination opinions and the relevant materials to the SDA.

Article 164

The SDA shall organize the State Drug Code Committee to conduct a comprehensive examination of the tentative drug standard.

The State Drug Code Committee shall, according to the implementation of the drug standard during the tentative period, the standards for the relevant products home and abroad and the relevant state requirements, give opinions on whether or not the said drug standard needs to be reviewed. If the standard needs to be reviewed, the relevant institutes for drug control shall be organized to carry out the review and inspection of the tentative drug standard.

Article 165

Inspection and review for the formalization of tentative standards for drugs of the same category manufactured by several drug manufacturing enterprises shall be carried out by the National Institute for the Control of Pharmaceutical and Biological Products or the institute for drug control designated by the SDA.

Article 166

With respect to the tentative standards for drugs of the same category formalized upon applications by different applicants, those approved later shall not be lower than those approved earlier, and the necessary inspection items of relevant materials etc shall be added in light of their respective technique characteristics.

Article 167

If an applicant needs to make supplementary trials or improve the materials, it shall finish the supplement or improvement within 50 days after receiving the notice on standard review and inspection, and shall submit them to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

Article 168

The SDA shall make an examination of the materials submitted by the State Drug Code Committee, and approve the formalization of a tentative drug standard by the form of Promulgation Document of State Drug Standards.

Article 169

With respect to drugs of the same category of which the tentative standard periods expire on different dates, the formalization of those expiring earlier shall be processed earlier. And for the drugs of which the tentative standard periods haven't expired, the State Drug Code Committee shall notify the applicants to file applications for formalization in advance with the drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government.

Article 170

If an applicant fails to file the application for formalization upon the expiration of the tentative standard period or if the tentative standard fails to conform to the requirements for formalization, the SDA shall cancel that standard and the registered number of approval for the drugs manufactured on the basis of such tentative standard. During the period when application for formalization of a tentative standard is processed, the drug manufacturing enterprise shall manufacture drugs pursuant to the tentative standard.

Section III Administration of Drug-relating Standard Materials

Article 171

Drug-relating standard materials shall refer to the materials that are for experiment use in the physical and chemical testing and biological methods specified in the drug standards, that are with determinable quantity and are used in the adjusting of equipment, evaluation of measuring methods or providing evaluations to the drugs for experiment, including standard articles, comparison articles, comparison medicine materials and reference articles.

Article 172

The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for demarcating and administering the state drug-relating standard materials, either may it organize the institutes for drug control, institutions for drug study or drug manufacturing enterprises of the relevant provinces, autonomous regions and municipalities directly under the Central Government to assist in the demarcating.

Article 173

When applying for the manufacturing of a new drug, the applicant shall submit the standard materials and raw materials for preparation of such drug to the National Institute for the Control of Pharmaceutical and Biological Products, and shall submit the study materials of the relevant standard materials.

Article 174

For the standard materials demarcated, the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for conducting a comprehensive technical examination of the selection of raw materials, the preparing methods, the demarcating methods, the demarcation results, the accuracy of fixed values, the metrological tracebility, the stability, and the conditions for repackaging and packaging etc, and shall make the conclusion whether or not the materials may be used as state drug-relating standard materials.

Chapter XV Provisions on Time Limits in Drug Registration

Article 175

Time limits in drug registration shall refer to the maximum time periods allowed for finishing the examination, inspection and supplementing of materials relating to drug registration.

Article 176

The drug administration of a province, autonomous region or municipality directly under the Central Government shall, upon receiving an application submitted by the applicant, organize within 5 days and finish within 30 days the on-spot investigation, sample selection and notification to the institute for drug control on making inspection over the samples, and shall submit the examination opinions and investigation report, together with the materials submitted by the applicant, to the SDA, and notify the applicant of the examination opinions at the same time.

Article 177

After receiving the notification on inspection and the samples, the institute for drug control shall finish the inspection within 30 days and produce the examination report.

For special drugs and vaccine products, the inspection may be finished within 60 days.

Article 178

If the inspection over samples and review of drug standard are needed, an institute for drug control shall finish the inspection and the review within 60 days.

For special drugs and vaccine products, the inspection and review may be finished within 90 days.

Article 179

The SDA shall, after receiving the materials submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, finish the acceptance examination within 5 days and decide on whether or not to accept the application.

Article 180

With respect to an application for registration of imported drugs, the SDA shall finish the acceptance examination within 30 days, and notify the National Institute for the Control of Pharmaceutical and Biological Products to organize the inspection.

Article 181

The National Institute for the Control of Pharmaceutical and Biological Products shall, after receiving the materials and samples, assign the relevant institute for drug control to conduct the inspection within 5 days.

Article 182

The institute for drug control undertaking the inspection over imported drugs shall, after receiving the materials, samples and relevant standard materials, finish the inspection within 60 days and send the inspection report to the National Institute for the Control of Pharmaceutical and Biological Products.

Article 183

The National Institute for the Control of Pharmaceutical and Biological Products shall, after receiving the reviewed standard for imported drugs, organize the experts to make a technical examination within 20 days, and may conduct review again with respect to the specific items according to the examination opinions.

Article 184

When handling the applications for drug registration, the SDA shall observe the following provisions on time limits for technical examination:

(1)

For clinical study of new drugs: within 120 days; for categories meeting the provisions of Article 49 of these Measures: within 100 days.

(2)

For manufacturing of new drugs: within 120 days; for categories meeting the provisions of Article 49 of these Measures: within 100 days.

(3)

For applications for drugs with existing state standards: within 80 days.

The time limits for technical examination of the application for import drug registration shall also observe the above provisions.

Article 185

When the SDA makes the technical examination for a drug registration application, if it is needed for the applicant to supplement materials, a notice on supplementing materials shall be issued once off.

The applicant shall finish supplementing the materials once off within 4 months pursuant to the requirements of the notice; for failure to supplement the materials within the prescribed time limit, the application shall be returned.

Article 186

If the applicant has any objections against the notice on supplementing materials, it may present its opinions within the prescribed time limit. If it still has objections, it may file written opinions with the SDA, explain the reasons and provide the technical materials and scientific basis, and the SDA shall make a decision after examination.

Article 187

With respect to an application that has been returned, if the applicant supplements and improves the relevant experiments or materials, and the provisions of these Measures on monitoring periods are met, the application may be filed again pursuant to the original procedures within 6 months after the returning of it.

Article 188

The SDA shall, after receiving the materials supplemented, finish the technical examination within no more than one third of the original time period allowed; for those meeting the provisions of Article 49 of these Measures, the technical examination shall be finished within no more than one fourth of the original time period allowed.

Article 189

The SDA shall finish the examination and approval within 40 days after finishing the technical examination; for categories meeting the provisions of Article 49 of these Measures, the examination and approval shall be finished within 20 days.

For the supplementary drug applications subject to the approval of the SDA, the SDA shall finish the examination and approval within 40 days; where technical examination is needed, the technical examination shall be finished within 60 days.

Article 190

The State Drug Code Committee shall finish the examination and decision on formalization of tentative drug standard within 60 days. An institute undertaking the task of standard review and inspection shall finish the review and inspection within 60 days, and send the review opinions and inspection report to the State Drug Code Committee. For special drugs and vaccine products, the period shall not exceed 90 days generally. And the review and inspection for formalization of the tentative standards for drugs of the same category manufactured by several drug manufacturing enterprises shall be finished within 80 days.

Article 191

Time limits provided for in these Measures shall be observed in the work of drug registration as a general principle. In case of special circumstances, the time period may be appropriately extended upon the approval by the SDA.

Chapter XVI Re-examination

Article 192

If the applicant has any objections against the decision made by the SDA on not granting the approval, it may file an application for re-examination with the SDA within 10 days and explain the reasons for re-examination.

The matters applying for re-examination shall be limited to those included in the original application.

Article 193

The SDA shall make the re-examination decision within 50 days from receiving the application for re-examination. If the original decision of not granting the approval is cancelled, the corresponding drug approval certifications shall be issued; if the original decision is sustained, the SDA will no longer accept any application for re-examination filed for a second time.

Article 194

If it is needed to conduct a technical examination for the application for re-examination, the SDA shall organize the relevant professionals to carry it out pursuant to the original application time limit.

Chapter XVII Penalty Provisions

Article 195

If an applicant submits false application materials and drug samples when applying for clinical study, the SDA will not approve the clinical study of the said drug and will give a warning to the applicant; if the clinical study has been approved, the official document approving the clinical study of the said drug shall be cancelled, and a fine of RMB 10,000 to 30,000 shall be imposed. If the circumstances are serious, the application for clinical trial of that drug filed by the said applicant will not be accepted within 3 years.

The SDA shall set up and promulgate the record of bad deeds of the applicants that submit false materials and samples.

Article 196

If an applicant submits false application materials and samples for drug registration when applying for the manufacturing or import of drugs, the SDA shall not approve that application and shall give a warning to the applicant; if the manufacturing or import has been approved, the drug approval certifications shall be cancelled, any application filed by that applicant will not be accepted within 5 years, and a fine of RMB 10,000 to 30,000 shall be imposed.

The SDA shall set up and promulgate the record of bad deeds of the applicants that submit false materials and samples.

Article 197

If the License for Drug Manufacturing of a drug manufacturing enterprise has been revoked, the registered number of approval for drugs held by that enterprise shall be invalidated automatically, and be written off by the SDA.

Article 198

If the Criterions for the Quality Control of Non-clinical Study of Drugs or the Criterions for the Quality Control of Clinical Trial of Drugs are not implemented in drug registration pursuant to the provisions, the offender shall be punished according to Article 79 of the Drug Administration Law.

Article 199

If an institute for drug control produces false inspection report when it undertakes the drug inspection needed in the examination and approval of drugs, it shall be punished according to Article 87 of the Drug Administration Law.

Article 200

If it is needed to make an experiment on the drug for a second time according to Article 22 of these Measures and the applicant refuses, the SDA will give a warning to it and order it to correct, if the applicant refuses to correct, it will be deprived of its qualification for applying for registration of drugs of such category.

Chapter XVIII Supplementary Provisions

Article 201

Days as used in the work time limits in these Measures shall refer to workdays, not including statutory holidays.

Article 202

With respect to Chinese medicine materials, the crude slices of Chinese medicine, and imported Chinese medicine materials that are subject to the administration by registered number of approval, the provisions on the administration of registration shall be formulated by the SDA separately.

Article 203

Administration of registration of biological, microbe, immunity and nucleic acid external diagnostic reagents shall follow the measures for the administration of registration of biological external diagnostic reagents promulgated by the SDA.

Article 204

Measures for the administration of the packaging materials, containers and supplementary materials directly contacting the drugs shall be formulated by the SDA separately.

Article 205

Provisions on the administration of the packaging, labels and specifications of drugs, as well as the commodity names of drugs shall be formulated by the SDA separately.

Article 206

Applications for registration of narcotics, psychotropics substances, toxic drugs for medical use and radioactive drugs shall, apart from following the provisions of these Measures, meet the relevant state provisions.

Article 207

Those applying for drug registration shall pay the registration fees pursuant to the provisions.

Article 208

These Measures shall enter into force on December 1, 2002. The Measures for the Examination and Approval of New Drugs, Measures for the Examination and Approval of New Biological Products, Provisions on New Drugs Protection and Technology Transfer, Measures for the Examination and Approval of Imitated Drugs and Measures for the Examination and Approval of Imported Drugs promulgated by the SDA on April 22, 1999 shall be nullified at the same time.