Laws of the People's Republic of China

No.27

The Measures for Examining Drug Advertisements have been deliberated and adopted by the State Food and Drug Administration and the State Administration of Industry and Commerce of the People's Republic of China They are hereby promulgated by the sequence number of the order of the State Food and Drug Administration, and shall go into effect as of May 1, 2007. Director of the State Food and Drug Administration, Shao Mingli

Director of the State Administration of Industry and Commerce, Zhou Bohua

March 13, 2007

Measures for Examining Drug Advertisements

Article 1

According to the Advertising Law of the People's Republic of China (hereinafter referred to as Advertising Law), the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), the Rules for Implementing the Drug Administration Law of the People's Republic China (hereinafter referred to as Rules for Implementing the Drug Administration Law) and other related state provisions on the supervision and administration of ads and drugs, the present Measures are enacted with a view to strengthening the administration of drug advertisements (hereinafter referred to as drug ads) and guaranteeing the authenticity and legality of drug ads.

Article 2

All the ads containing drug names, applicable diseases (functions and indications) or other drug-related content and published through various mediums or in various forms belong to drug ads and shall be examined under the present Measures.

As regards a nonprescription drug ad that only publicizes the name of the drug (including the general name and commodity name) or a prescription drug ad that only publicizes the name of the drug (including the general name and commodity name) on designated professional publications of medicine science and pharmacy, the examination is not required.

Article 3

A drug ad for being examined may not pass the examination unless it complies with the following laws, regulations and related provisions:

(1)

Advertising Law;

(2)

Drug Administration Law;

(3)

Rules for Implementing the Drug Administration Law;

(4)

Standards for Examining and Issuing Drug Ads;

(5)

Other state provisions on administrating ads.

Article 4

The drug administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government shall be the examination organs of drug ads and shall, within their respective administrative regions, take charge of examining the drug ads. The administrative departments of industry and commerce at or above the county level shall be the supervisory and administrative organs of drug ads.

Article 5

The State Food and Drug Administration shall conduct guidance and supervision over the examination work of drug ads as made by the examination organs of drug ads, and shall, according to law, punish the examination organs for any violation of the present Measures.

Article 6

Only a qualified manufacturing or trading enterprise of the drug may file an application for a drug license number. In case a trading enterprise files such application, the consent of the manufacturing enterprise shall be obtained.

An applicant may entrust an agent to deal with the application matters for a drug ad license number on behalf of it.

Article 7

An application for a drug ad license number shall be filed with the examination organ of drug ads at the locality of the manufacturing enterprise of the drug.

An application for the ad license number of an import drug shall be filed with the examination organ of drug ads at the locality of the agency of the import drug.

Article 8

For applying for a drug ad license number, an applicant shall provide a Drug Ad Examination Form (Attached List 1), with the electronic document of the sample manuscript (film or tape) consent with the content to be published and that of the application form for drug ad attached, and, meanwhile, provide the following true, legal and effective evidentiary documents:

(1)

Photocopy of the Business License of the applicant;

(2)

Photocopy of the Drug Manufacturing License or Drug Trading License of the applicant;

(3)

In case the applicant is a trading enterprise of the drug, the original evidentiary document on the fact that the manufacturing enterprise agrees to its status as applicant shall be submitted;

(4)

Where the applicant entrusts an agent to apply for a drug ad license number, the original authorization letter produced by the applicant and the photocopy of the agent's business license and other evidentiary documents on the agent's subject status shall be provided;

(5)

Photocopies of the drug approval certificates (including Registration Certificate for Import Drug and Registration Certificate for Medical Product), photocopy of the approved drug instructions as well as the label and instructions actually used;

(6)

As regards a nonprescription drug ad, a photocopy of the examination and registration certificate of the nonprescription drug or photocopies of the related evidentiary documents shall be provided;

(7)

For applying for the ad license number of an import drug, the photocopies of the related evidentiary documents on the qualification of the drug import agencyshall be provided;

(8)

In case the ad involves the commodity name of the drug, the registered trademark or patent, etc, the photocopies of the related evidentiary valid documents and other evidentiary documents confirming the authenticity of the content of the ad shall be provided.

The photocopy of any evidentiary documents to be provided as provisioned in this Article shall be affixed with the seal of the entity holding it.

Article 9

An examination organ of drug ads may not accept an enterprise's application for drug ad under any of the following circumstances:

(1)

Any of the circumstances under which the application may not be accepted as provisioned in Articles 20, 22 and 23 of the present Measures;

(2)

The administrative procedure for revoking the drug ad license number is going on.

Article 10

Where the application materials are complete and satisfy the statutory requirements, an examination organ of drug ads shall issue a Notice of Drug Ad Acceptance after receiving an application for a drug ad license number, and, where they are not complete or fail to satisfy the statutory requirements, it shall, on the spot or within 5 workdays, inform the applicant of the content to be corrected once and for all ; in case it fails to do so within the prescribed time limit, the day of the receipt of the application materials shall be deemed as the day of acceptance.

Article 11

An examination organ of drug ads shall examine the authenticity, legality and validity of the evidentiary documents provided by the applicant within 10 workdays since its acceptance of the application and examine the content of the ad in accordance with law. Where the drug ad passes the examination, it shall issue a drug ad license number; otherwise, it shall make a decision on rejecting issuing a drug ad license number, inform the applicant of the decision in written form and make explanations, and, meanwhile, inform the applicant of its right to apply for an administrative reconsideration or lodge an administrative lawsuit in accordance with law.

As regards an approved drug ad, the examination organ of drug ads shall report it to the State Food and Drug Administration for archival filling and send the approved Drug Ad Examination Form to the ad supervisory and administrative organ at the same level for archival filling. In case the State Food and Drug Administration finds any problem in the drug ad reported for archival filling, it shall order the examination organ of drug ads to make corrections.

The drug supervisory and administrative departments shall timely publicize the approved drug ads to the general public.

Article 12

The archive-filing formalities shall be gone through beforehand at the examination organ of drug ads of the place where the ad is to be published, if the drug ad is to be published in any province, autonomous region, or municipality directly under the Central Government other than the place where the manufacturing enterprise of the drug or the import drug agency is located (hereinafter referred to as publishing drug ad in any other place).

Article 13

For publishing any drug ad in any other place, the following materials shall be provided:

(1)

Photocopy of the Drug Ad Examination Form;

(2)

Photocopy of the approved drug instructions;

(3)

For a TV or radio ad, a tape, CD or any other medium carrier with content identical with the content passing the examination shall be submitted;

The photocopy of any evidentiary document to be provided as provisioned in this Article shall be affixed with the seal of the entity holding it.

Article 14

As regards an application for the archive-filing of a drug ad published in any other place filed according to the provisions of Articles 12 and 13 of the present Measures, the examination organ of drug ads shall, within 5 workdays as of the acceptance of the archive-filing application, put it on record, endorse the word "Filed" on the Form, affix the special seal for the examination of drug ads and send a copy of the Form to the ad supervisory and administrative organ at the same level for future reference.

Where the examination organ of drug ads at the place where a drug ad is to be put on record holds that the drug ad fails to comply with the related provisions, it shall fill in the Opinion on the Archive-filing of Drug Ads (Attached List 2) and send it to the original examination organ of drug ads for reexamination, and a copy thereof shall be sent to the State Food and Drug Administration.

The original examination organ shall inform the examination organ of drug ads at the place where the drug ad is to be put on record of its opinion within 5 workdays since the day when it receives the Opinion on the Archive-filing of Drug Ads. In case the two examination organs of drug ads can't achieve a consensus, the State Food and Drug Administration may be invited to make a ruling thereon.

Article 15

A drug ad license number's valid period shall be one year, and once the period expires it shall become invalid.

Article 16

When publishing an approved drug ad, no content of the ad may be altered. In case it is necessary to alter any content, the drug ad license number shall be reapplied.

Article 17

In case a drug ad applicant publishes the drug ad by itself, the original Drug Ad Examination Form shall be kept for two years for future reference.

In case an ad publisher or operator is entrusted by a drug ad applicant to act as an agent or publish the drug ad, it shall check the original Drug Ad Examination Form, publish the drug ad on the basis of the examined and approved content, and keep the photocopy of the Form for two years for future reference.

Article 18

Where an approved drug ad falls within any of the following circumstances, the original examination organ of the drug ad shall issue a Notice on the Reexamination of Drug Ads (Attached List 3) to the applicant of the drug ad and reexamine the drug ad in accordance with law. The drug ad may be continually published during the reexamination period:

(1)

The State Food and Drug Administration holds that the content of the approved drug ad fails to comply with the related provisions;

(2)

An ad supervisory and administrative organ at the provincial level or above suggests the reexamination of the drug ad;

(3)

Any other circumstance under which the examination organ of drug ads holds that it is necessary to reexamine.

Where, upon reexamination, the original examination organ of drug ads holds that the drug ad fails to meet the statutory conditions, it shall take back the Drug Ad Examination Form and cancel the original drug ad license number.

Article 19

The examination organ of drug ads shall write-off the drug ad license number under any of the following circumstances:

(1)

The Drug Manufacturing License or Drug Trading License has been canceled;

(2)

The approval certifications on the drug have been cancelled or written-off;

(3)

The State Food and Drug Administration or the drug supervisory and administrative department of the province, autonomous region, or municipality directly under the Central Government has ordered to suspend the production, sale and use of the drug.

Article 20

In case false publicity is made by altering an approved drug ad's content without authorization, the drug supervisory and administrative department shall order to stop such publishing immediately, revoke the ad license number of such drug and may not accept the application for the examination and approval of any ad on such drug within one year.

Article 21

As regards any illegal drug ad that enlarges the scope of applicable diseases (functions and indications) of the drug at will, absolutely exaggerates the curative effects of the drug and severely cheats and misleads the consumers, once the drug supervisory and administrative department at the provincial level or above finds, an administrative coercive measure shall be adopted to suspend the sale of such drug within its jurisdiction and, meanwhile, order the enterprise illegally publishing the drug ad to publish a notice of correction on the corresponding local medium. The drug supervisory and administrative department at the provincial level or above shall, within 15 workdays, make a decision on releasing the administrative coercive measure after the notice is published; in case it is necessary to check the drug, the drug supervisory and administrative department shall, within 15 days since the day when the written check report is sent, make a decision on whether to release the administrative coercive measure or not.

Article 22

As regards an enterprise providing any false application material for the examination and approval of a drug ad, once the examination organ of drug ads finds during the acceptance or examination, this enterprise's application for the examination and approval of any ad on such drug may not be accepted within one year.

Article 23

In case an enterprise obtains a drug ad license number by submitting false application materials, the examination organ of drug ads shall, after finding, revoke the drug ad license number and may, within three years, not accept this enterprise's application for the examination and approval of any ad on such drug.

Article 24

In case the license number of a drug ad has been taken back, written-off or cancelled according to Articles 18, 19, 20 or 23 of the present Measures, the publication thereof shall be suspended at once; the examination organ of drug ads of any other place shall stop accepting such enterprise's application for the archive-filing of such drug ad's approved license number.

In case an examination organ of drug ads decides to take back, write-off or cancel a drug ad license number according to Articles 18, 19, 20 or 23 of the present Measures, it shall inform the ad supervisory and administrative organ at the same level to deal with it in accordance with law within 5 workdays since the day when it makes such administrative handling decision.

Article 25

In case an enterprise publishes a drug ad in other place without sending an archive-filing application to the examination organ of drug ads at the place where the drug ad is published, once it is found out, it shall be order to go through the formalities for archive-filing within a prescribed period, where it fails to do so, the publishing activities of such drug ad shall be ordered to be stopped in that place.

Article 26

The drug supervisory and administrative departments at the county level or above shall monitor and inspect the publication of the examined and approved drug ads. As regards the illegally published drug ads, the drug supervisory and administrative departments at each level shall fill in the Notice on Transferring Illegal Drug Ads (Attached List 4) and transfer them together with such materials as the sample pieces of these illegal drug ads to the ad supervisory and administrative organs for investigating and handling at the same level ; as regards an other-place publication of a drug ad with approved contend altered without authorization, the examination organ of drug ads at the place where the drug ad is published shall, according to Article 92 of the Pharmaceutical Administration Law and Article 20 of the present Measures, put forward a suggestion on revoking the license number of the drug ad to the original examination organ of drug ads.

Article 27

As regards any illegal drug ad with serious circumstance, the drug supervisory and administrative department under the province, autonomous region, or municipality directly under the Central Government shall publicize an announcement thereon and report it to the State Food and Drug Administration, which shall, on a consolidated and regular basis, publicize such reports.

As regards any illegal drug ad with serious circumstance, when necessary, the State Administration of Industry and Commerce and the State Food and Drug Administration shall jointly publicize an announcement thereon.

Article 28

In case a drug ad is published without being examined and approved or the content of a published drug ad is inconsistent with the examined and approved one, the ad supervisory and administrative organ shall punish according to Article 43 in the Advertising Law; in case it constitutes a false ad or a false and misleading publicity, the ad supervisory and administrative organ shall punish according to Article 37 of the Advertising Law and Article 24 of the Anti-Unfair Competition Law.

In case the ad supervisory and administrative organ, when investigating and punishing a case of illegal drug ad, finds it is necessary to determine certain professional technical content as involved in the case, it shall send a written notice on the content to be determined to the drug supervisory and administrative department at the provincial level or above, which shall, within 10 workdays since the day when the notice is received, feed back the determination result to the ad supervisory and administrative organ.

Article 29

The working personnel undertaking the examination and supervision of drug ads shall be subject to the training on the Advertising Law, the Drug Administration Law and other related laws and regulations. In case any working personnel of the examination organs of drug ads and the supervisory and administrative organs thereof neglects his duties, abuses his power or conducts any self-exerting misconduct, administrative punishment shall be imposed. In case any crime is established, criminal liabilities shall be investigated in accordance with law.

Article 30

A drug ad license number shall be in the form of "No. 0000000000 of X Drug Ad Examination (Video)", "No. 0000000000 of X Drug Ad Examination (Audio)" or "No. 0000000000 of X Drug Ad Examination (Words)", among which, "X" means the abbreviation of a province, autonomous region, or municipality directly under the Central Government, "0" consists of 10 digits, the first 6 shall be the date when the examination is conducted and the last 4 shall be the approved ad's serial number. "Video", "Audio" and "Words" means the medium forms for publishing ads.

Article 31

The present Measures shall go into effect as of May 1, 2007. The Measures for Examining Drug Ads (No. 25 of the State Administration of Industry and Commerce), which were promulgated by the State Administration of Industry and Commerce and the Ministry of Health on March 22, 1995, shall be repealed at the same time.