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| Category | PUBLIC HEALTH AND MEDICINE | Organ of Promulgation | The State Council | Status of Effect | In Force |
| Date of Promulgation | 1989-02-27 | Effective Date | 1989-02-27 |
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Measures for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China |
|---|
Article 1 These Measures are formulated in accordance with the
Pharmaceutical Administration Law of the People's Republic of China
(hereinafter referred to as Pharmaceutical Administration Law).
Article 2 These Measures are applicable to any units or individuals who
are related to the production, selling, using, testing and examination or
scientific research of medicines.
These Measures are also applicable to the pharmaceutical enterprises in
the People's Liberation Army that are engaged in the production of medicines
for civilian use.
Article 3 In the production and selling of pharmaceuticals, social
benefit shall be taken as the prime concern. The production, selling or use of
fake or inferior medicines is strictly prohibited.
Without authorization no production or sales of pharmaceuticals or Article 4 The administrative department of health under the State Council (1) to enforce the Pharmaceutical Administration Law and these Measures; (2) to draft laws and regulations related to the supervision and (3) to promulgate the Pharmacopoeia of China and the national standards (4) to examine and approve new medicines and to verify and issue approval (5) to exercise supervision over the production, trading and use of (6) to make investigation and appraisal of the curative effect and side (7) to make decisions on disciplinary sanctions in accordance with the Pharmaceutical administration organs in the administrative departments of Article 5 The medicine inspection organs set up by the administrative Article 6 Medicine supervisor(s) shall be appointed in the administrative The duties of medicine supervisors at all levels shall be defined Article 7 When carrying out their duties, the medicine supervisors are The medicine supervisors may temporarily seal up some medicine pending Article 8 The procedures for examination and approval as stipulated in Article 9 If a pharmaceutical production enterprise desires to set up a Article 10 The procedures for examination and approval stipulated in (1) for a wholesale drug enterprise, an application must be submitted to (2) for a retail drug enterprise, an application must be submitted to the The department in charge of the production and trading of pharmaceuticals Article 11 The competent department for the production and trading of Article 12 If a medical treatment unit needs to prepare some medicaments, The administrative department of health is required to make a decision Article 13 The term of validity for a Pharmaceutical Producer Licence, a If an enterprise has gone bankrupt or has wound up business, the license Article 14 Pharmaceutical Producer Licence, Pharmaceutical Trading Article 15 The state encourages research in and development of new Article 16 Procedures for the examination and approval of new medicines Article 17 Before a new medicine is put to clinical testing, the research Article 18 Clinical testing or clinical verification of a newly developed Article 19 After new medicines have been clinically tested and verified The administrative department of health under the State Council is Article 20 The administrative department of health under the State Article 21 The clinical testing or clinical verification unit, the Article 22 For the production of a new medicine, the production unit To produce a certain kind of medicine for which the state, the province, Article 23 When applying for a Registered Document of Approval for a Article 24 The Registered Document of Approval for a medicine is valid Article 25 The administrative department of health under the State Article 26 The state shall practise The Norms For Quality Control of Article 27 All the newly built pharmaceutical factories and the extension Article 28 Pharmaceutical production enterprises shall be staffed with (1) a factory manager in charge of pharmaceutical production and quality (2) the post of the director in charge of pharmaceutical production (3) the responsible workshop technician is required to have an education (4) the technical workers are required to go through technical training (5) with respect to those pharmaceutical factories processing traditional Article 29 Pharmaceutical enterprises are required to have factory Article 30 Pharmaceutical enterprises are required to have their own Article 31 Traditional Chinese medicine factories (including those (1) Raw medicinal herbs must be pretreated by way of picking, sorting, (2) See to it that the processing of traditional Chinese medicine into (3) Traditional Chinese medicine technical personnel shall be put in Article 32 Medicines must be made in accordance with the verified Article 33 Pharmaceutical enterprises are required to have a complete Article 34 It is required that all raw materials and additives needed in Article 35 Pharmaceutical enterprises must strengthen medicine quality Article 36 Pharmaceutical trading enterprises shall be staffed with full (1) A wholesale pharmaceutical trading enterprise shall set up quality (2) A retail pharmaceutical trading enterprise shall be staffed with a (3) Non-pharmaceutical workers newly recruited or staffed to engage in Article 37 The business premises, facilities, storage facility and clean (1) The storage facilities must meet the requirements by the physical (2) A pharmaceutical trading enterprise that also deals in other Article 38 Pharmaceutical trading enterprises may prepare or process Article 39 Pharmaceutical trading enterprises are required to establish a Article 40 Pharmaceutical trading enterprises must examine carefully the Article 41 Medical treatment units that prepare their own medicaments (1) the post in charge of medicament preparation and inspection in Such a post in a hospital under the county level must be held by a person (2) preparation of medicaments must be made in a proper building with Article 42 In preparing medicaments, it is required to strictly abide by Article 43 The medical treatment units that prepare their own medicaments The medicine inspection lab shall sign and issue a quality certificate for Article 44 Medical treatment units may prepare only those medicaments Article 45 Medical treatment units are required to prepare their Article 46 In medical treatment units, no divisions shall be allowed to Article 47 Violation of Article 15 of the Pharmaceutical Administration Article 48 Those who make or sell or use fake medicine shall have their Article 49 Those who make or sell or use medicine of inferior quality Article 50 Any one of the following acts of making, selling or using fake 1. a counterfeit of other medicine with narcotics, psychotropic 2. an act of making or selling fake medicine or inferior medicine to be 3. an act of making, selling or using fake or inferior medicine which has 4. an act of making, selling or using fake or inferior medicine after 5. any act that shall be imposed with severe punishment as stipulated in Article 51 Any units engaged in the production, trading or preparation of Article 52 Units or individuals that have committed any of the following 1. to import medicines from abroad for the first time without approval by 2. to import medicines from abroad without inspection by the medicine 3. to conduct clinical testing or verification of new medicine without 4. to change the technological process of production without approval by 5. to prepare medicaments for sale or for sale in devious manner by Article 53 Any unit or individual that has committed any one of the 1. fail to indicate the expiry date of the medicine which ought to be 2. violate the regulations concerning inner packaging of Chinese medicinal 3. fail to label the packing as required or the items printed on the label 4. to purchase or sell newly discovered Chinese medicinal materials or Article 54 Any individual at the medicine inspection organs or any Article 55 Labels for narcotics, psychotropic substances, toxic drugs, Article 56 The right to interpret these Measures resides in the Article 57 These Measures shall go into effect as of the date of (1) For the attached drawings, see page 1505, Volume III, LAWS AND
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preparation of medicaments shall be allowed.
Chapter II Responsibility for the Supervision and Administration of
Pharmaceuticals
is in charge of the nationwide supervision over and administration of
pharmaceuticals. Its principal responsibilities are as follows:
administration of pharmaceuticals, and to formulate provisions for the
implementation of each law or regulations;
for medicines;
certificates thereof;
pharmaceuticals;
effect of the medicines already put into production and to provide and publish
information related to the quality;
Pharmaceutical Administration Law and these Measures.
health at or above the county level are in charge of the supervision over and
administration of pharmaceuticals within their respective jurisdiction.
departments of health at or above the county level shall, under the latter's
leadership, conduct medicine inspection in accordance with the standards for
medicines set by the state and by the administrative department of health at
the level of province, autonomous region or municipality directly under the
Central Government.
department of health at or above the county level. Medicine supervisors at the
state level shall be entrusted by the administrative department of health
under the State Council by credentials. Medicine supervisors at the
provincial, autonomous region or municipal government (directly under the
Central Government) level and at the autonomous prefecture, municipality or
county level shall be nominated respectively by the administrative departments
of health and entrusted with credentials by the people's governments at the
corresponding levels.
separately by the administrative department of health under the State Council.
required to present their credentials before they take sample testing and ask
for relevant technical data, with a receipt in accordance with the state
stipulations. They are required to keep confidential the technical data
provided by the production enterprise and scientific research unit.
further settlement. It is required of them to state the term of sealing up
which shall not normally exceed 15 days.
Chapter III Procedure for the Verification and Approval of Licenses
Paragraph 1 of Article 4 of the Pharmaceutical Administration Law denote that
the establishment of a pharmaceutical producing enterprise (including all
forms of inland associated enterprises, Chinese-foreign equity joint ventures
and contractual joint ventures and foreign invested enterprises) shall
involve, in addition to applying for approval for the capital construction
of the enterprise in accordance with state stipulation, the following steps:
(1) the enterprise or its leadership organ submits an application to the
competent department for the production and trading of pharmaceuticals of the
province, autonomous region or municipality directly under the Central
Government where the enterprise is located for examination and approval and
then refer it to the administrative department of health at the same level.
(2) upon approval by the administrative department of health of the province,
autonomous region or municipality directly under the Central Government, a
Pharmaceutical Producer License shall be issued. The department in charge of
the production and trading of pharmaceuticals and the administrative
department of health are required to make a decision within 30 days of receipt
of complete application materials.
branch factory or any additional workshops outside the premise of the factory,
it is required to submit an application to the department in charge of the
production and trading of pharmaceuticals at the level of the province,
autonomous region or municipality directly under the Central Government for
examination and approval and then refer it to the administrative department of
health at the same level for a Pharmaceutical Producer License, on which the
status of the new set-up (a branch factory or a workshop) and its production
scope must be clearly stated.
Paragraph 1 of Article 10 of the Pharmaceutical Administration Law denote that
a pharmaceutical trading enterprise (including specialized and non-specialized
whole-sale or retail drug stores or companies) should apply for a
Pharmaceutical Trading Enterprise Licence in accordance with the following
provisions:
the department in charge of the production and trading of pharmaceuticals at
the level of the province, autonomous region or municipality directly under
the Central Government for examination and approval and then be referred to
the administrative department of health at the same government level for
verification and approval betore a Pharmaceutical Trading Enterprise License
is issued;
department in charge of the production and trading of pharmaceuticals at the
autonomous prefecture, municipality or county government level for examination
and approval and then be referred to the administrative department of health
at the same government level for verification and approval before a
Pharmaceutical Trading Enterprise License is issued.
and administrative department of health are required to make a decision within
30 days of receipt of complete application materials.
pharmaceuticals stated in Articles 4, 10 and 22 of the Pharmaceutical
Administration Law refers to those pharmaceutical administration organs or
departments appointed by the people's government at or above the county level.
it is required to submit an application to an administrative department of
health at the level of the province, autonomous region or municipality
directly under the Central Government for examination and approval betore a
Dispensing Permit is granted.
within 30 days of receipt of complete application materials.
Pharmaceutical Trading Enterprise Licence, or a Dispensing Permit is 5 years.
If the licensee wishes to continue its production or trading or making
medicament preparation upon expiration of the licence, it must reapply for
permission. The entire application procedures must be repeated.
it is holding should be cancelled by the administrative department of health
that has issued it.
Enterprise Licence, and Dispensing Permit shall be printed exclusively by the
administrative department of health under the State Council.
Chapter IV Examination and Approval of New Medicines
medicines. All pharmaceutical research units, medical colleges, pharmaceutical
production enterprises, medical treatment units or individuals with the
necessary conditions are encouraged to engage in the research in and
development of new medicines.
shall be formulated by the administrative department of health under the State
Council.
and development unit of this medicine is required to submit an application
together with the relevant data and samples in accordance with the provisions
for the examination and approval of new medicines.
medicine must be conducted in the medical treatment unit(s) approved by the
administrative department of health at the level of the province, autonomous
region or municipality directly under the Central Government.
and have passed the examination by the administrative departments of health at
the level of the province, autonomous region or municipality directly under
the Central Government, the research and development unit of these new
medicines shall submit an application to the administrative department of
health under the State Council for examination and approval and New Medicine
Certificates shall be issued accordingly.
required to call, at the earliest possible time, the Medicine Appraisal
Committee to make technical appraisal of the newly developed medicine after
the complete application materials are received. A decision must be made
within two months of the technical appraisal.
Council and those in the provinces, autonomous regions or municipalities
directly under the Central Government may set up a Medicine Appraisal
Committee which is composed of experts in medical science and pharmacology
from medical treatment units, scientific research units, pharmaceutical
factories and medical colleges.
department to examine and approve the newly developed medicine and individuals
so involved are required to keep confidential the relevant data, figures,
production techniques provided by a unit or individual that has developed the
new medicine.
Chapter V Registered Document of Approval for Medicines
shall submit an application to the administrative department of health under
the State Council for examination and approval upon which a Registered
Document of Approval shall be issued to the unit. However, this does not
apply to the production of traditional Chinese medicine in ready-to-use forms.
autonomous region or municipality directly under the Central Govermnent has
already set standards, the production unit is required to submit an application
to the administrative department of health at the level of the province,
autonomous region or municipality directly under the Central Government. After
consulting the department in charge of the production and trading of
pharmaceuticals at the same level, the administrative department of health
shall make a decision on whether to issue the Registered Document of Approval
to the unit. However, this does not apply to the production of traditional
Chinese medicine in ready-to-use forms.
medicine, the production unit must present testing samples and relevant data
to the medicine inspection organ appointed by the administrative department of
health at the level of the province, autonomous region or municipality
directly under the Central Government. The medicine inspection organ is
required to make a test report and refer it to the administrative department
of health for examination and approval, which shall, within 30 days of
receipt of the test report, make a decision on whether to issue the Registered
Document of Approval to the unit.
for 5 years, during which time no change of the registration number shall be
allowed. The Registered Document Approval of a medicine shall become invalid
if the medicine has not been produced for 3 years.
Council is required to organize investigations of medicines that have been
approved for production. The Medicine Appraisal Committee shall revoke the
Registered Document of Approval if it discovers by appraisal that the
medicine's curative effects are uncertain, that they produce serious adverse
reactions, or that for other reasons they are harmful to people's health.
Chapter VI Administration of Pharmaceutical Production Enterprises
Medicine Production. The administrative department of health under the State
Council shall formulate The Norms For Quality Control of Medicine Production
and supervise the implementation thereof. The departments in charge of the
production and trading of medicines may formulate specific rules to guide the
gradual implementation of the Norms.
or rebuilt workshops of the existing pharmaceutical factories are required to
meet the requirements stipulated in the Norms For Quality Control of Medicine
Production. The existing pharmaceutical enterprises are required to establish
hygiene rules and regulations to ensure medicine quality and strive to meet
all the requirements stipulated in the Norms For Quality Control of Medicine
Production gradually, and in a planned way.
professional technical personnel and skilled workers who must meet the
following qualifications:
control must be familiar with the techniques involved in pharmaceutical
production;
technology and quality inspection shall be held respectively by a
pharmaceutist, an assistant engineer or a herbdruggist, depending on the kind
of medicine being produced;
of at least the technical school level and with 5 years or more production
experience;
before they are allowed to operate independently;
Chinese medicines into ready-to-use forms, if they are unable to meet the
requirement stated in Item (2) of Article 28 of these Measures, the relevant
posts shall be held by Chinese medicinal herb personnel who are familiar with
the properties of the herbal medicine processed, can appraise medicinal herbs
and have a mastery of the production techniques. These personnel must be
examined by and registered with the administrative department of health above
county level.
premises, facilities and sanitory environment to ensure the quality of the
medicine. They must be kept clean and tidy. If they are engaged in the
preparation of transfusion medicament and powdered injection, they must have
ultra clean conditions and superclean environment.
quality inspection organ and personnel, as well as necessary instrument and
equipment to ensure the quality of their products.
traditional Chinese medicine workshops in Western medicine factories) must not
only meet the requirements stipulated in Articles 28, 29, 30 and 32 of these
Measures but also abide by the following stipulations:
washing and baking according to the relevant requirements.
ready-to-use forms (including batching, grinding and packaging) shall be done
in an environment free from contamination.
charge of quality control of the Chinese medicine produced in the Western
medicine facteries.
standards and through the fixed technical processes. If a pharmaceutical
factory intends to make any change in the production technique which may
affect the quality of the medicine, it is required to submit an application to
the administrative department of health at the level of the province,
autonomous region or municipality directly under the Central Government for
examination and approval.
production record and lab testing record on file. These records shall be kept
for one year after the expiry date of the recorded batch of medicine. With
respect to medicines without expiry dates, their records shall be kept for 3
years.
the production of medicines, the containers and packaging material that may
directly contact the medicine must meet the requirements of the state
pharmacopoeia or other pharmaceutical standards. Pharmaceutical factories that
plan to use other kinds of materials are required to report their plans to the
administrative department of health for the record.
control. All kinds of medicines are subject to quality inspection by their own
medicine inspection organs before leaving the production premises. A quality
tag or lab testing report shall be put in the interior package of quality
products. Those medicines that fail to pass the quality inspection shall not
be allowed to leave the production premises.
Chapter VII Administration of Pharmaceutical Trading Enterprises
time pharmaceutical technical personnel who must meet the following
qualifications:
inspection organs which shall be put under the charge of professional
pharmacists of Chinese or Western medicine.
pharmacist or a Chinese medicine pharmacist or a full time pharmaceutical
staff worker who has been examined and registered by the administrative
department of health at or above county level.
pharmaceutical preparation, purchasing, storage keeping or marketing of
medicines are required to go through professional training before they are
allowed to work independently.
environment of a pharmaceutical trading enterprise must meet the following
requirements:
properties and chemical characters of medicines. The storage must be well
equipped against dust, rats and deterioration. For those medicines which need
to be kept away from light and in low temperature, there must be light lock
and thermal protective storage devices.
merchandise is required to install separate counters for these merchandise. No
medley of medicine and other articles in the same counter shall be allowed.
Chinese medicine (including slicing, roasting, baking, shimmering, etc.) or
make up prescriptions for patients. However, they may not make any
ready-for-use Chinese medicine for sale.
strict quality checking system and a storage system which includes stock
checking in and out and stock protection.
stock of medicine prior to its purchase. The items for examination shall
include its name, producer's name, batch number, quality certificate,
registered document (number) of approval, registered trade mark, packing and
exterior quality. With respect to Chinese medicinal materials, it is required
to examine the packing which must include its name, place of origin, name of
consignor and quality inspection mark.
Chapter VIII Administration of Medicaments Prepared by Medical Treatment
Units
shall meet the following requirements:
hospitals at or above the county level (including these medical treatment
units with more than 100 wardbeds in factories, mines, enterprises or
institutions) shall be held by a person who bears at least the title of senior
pharmacist.
who bears at least the title of pharmacist.
adequate facilities and in clean and tidy environment. Places for preparation
of sterilized medicaments must have a locker room, buffer room, wash room,
preparation room, filling and sealing room, sterilization room, packing room
and air conditioning. Places for preparation of infusion and transfusion
medicaments are required to have superclean conditions.
the operating rules, quality inspection rules and hygiene rules. It is
required to have detailed and complete records for the preparation of each
batch of medicament.
are required to have appropriate medicament inspection labs.
those medicaments that have passed the inspection and may be adopted for
clinical application. Rejects shall not be allowed for clinical use.
that are to be used clinically or in research by themselves and that are not
available on the market or insufficiently supplied. These medicaments may not
go to the market or do so in a devious manner.
medicaments for clinical use in conformity with the norms for the preparation
of clinical medicaments stipulated by the administrative department of health
at the level of the province, autonomous region or municipality directly under
the Central Government and report to the local administrative department of
health for the record.
prepare and supply clinical medicaments except the division of pharmacy and
the division of radiosolope.
Chapter IX Penalty Provisions
Law and violation of Chapter VIII of the same law related to the
administration of advertisements shall have disciplinary sanctions imposed by
the administration department for industry and commerce; violation of the
Pharmaceutical Administration Law and these Measures shall have disciplinary
sanctions imposed by the administrative department of health at or above
county level with a written penalty notice. It is required to state a quality
inspection result on a penalty notice for fake medicine and medicine of
inferior quality. All the forfeit shall be turned in to the national treasury.
fake medicines and illegal gains confiscated. The administrative department of
health shall impose a maximum fine five times or less the price of the
standard medicine which the fake equivalent is used to pass off for according
to the seriousness of the case.
shall have their inferior medicine and illegal gains confiscated. The
administrative department of health shall impose a maximum fine three times or
less the price of the standard medicine which the inferior equivalent is used
to pass off for according to the seriousness of the case.
or inferior medicines shall be considered as a serious case on which the
administrative department of health shall impose severe disciplinary sanctions:
substances, toxic drugs or radioactive drug or vice versa;
mainly administered to babies or infants;
produced harmful results as to endanger people's health;
being penalized;
other laws and regulations.
medicines without obtaining the Pharmaceutical Producer Licence,
Pharmaceutical Trading Enterprise Licence or Dispensing Permit shall be
ordered to suspend production, business operations or preparation of such
medicines. The medicines and the illegal gains therefrom shall all be
confiscated and the administrative department of health may impose a maximum
fine five times the price of the standard medicine or medicament, according to
the seriousness of the case.
violations shall be given a disciplinary warning or penalized with a maximum
fine of 20,000 RMB yuan according to the seriousness of the case:
the administrative department of health under the State Council;
inspection organ at the border port;
authorization;
the administrative department of health and, as a result, the quality of the
medicine has been degraded;
medical treatment units.
following acts shall be given a disciplinary warning or penalized with a
maximum fine of 10,000 RMB yuan according to the seriousness of the case:
indicated;
materials or protective packaging of pharmaceuticals for shipment;
or on the package insert are not in conformity with the requirements;
those introduced from abroad that have not been examined and approved.
medicine supervisor who abuses his power or engages in malpractices for
personal gains shall be given a disciplinary sanction by the administrative
department if the offence is not very serious; if the case is serious as to
constitute a crime, he shall be prosecuted for criminal responsibility
according to law.
Chapter X Supplementary Provisions
radioactive drugs and medicines for external application shall be designed as
follows (See the attached drawings (Note (1)).
administrative department of health.
promulgation.
Note:
REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED
MATTERS, China Legal System Publishing House, July, 1991. - The Editor
URL: http://www.asianlii.org/cn/legis/cen/laws/mftiotpal662