(With the approval of the State Administration for Industry and Commerce and the Ministry of Public Health, the Measures on Examination and Approval of Drug Advertisements are promulgated and take effect on March 22, 1995)
These measures are formulated in accordance with the Advertisement Law of the People's Republic of China and the Drug Management Law of the People's Republic of China.
All drug advertisements produced in whatever forms or published on whatever media, including the publication of leaflets by either drug producers or sellers, shall be subject to the examination and approval by relevant drug administrative authorities, according to these Measures.
The examination and approval of drug advertisements are based upon the following laws and regulations:
1) The Advertisement Law of the People's Republic of China
2) The Drug Management Law of the People's Republic of China.
3) The State's relevant regulations on advertising administration and the examination standards of advertising supervision departments.
The State public health administration and medical administrations at the provincial, (autonomous) regional, and municipal levels (hereinafter referred to as provincial-level public health supervision departments) are responsible for the examining and approving drug advertisements, under the guidance of the advertisements supervision departments at the same level.
The examining and approving department of drug advertisements is responsible for making suggestions to the supervision department in dealing with unlawful drug advertisements.
Advertisements of newly-developed drugs or overseas-produced drugs and those advertisements to be published on the major media can only be released after they have been examined and approved by the State Council public health administrative department and been given an approval certificate.
Other drug advertisements should be examined and approved by the provincial-level public health administrative departments of the place of drug production. Advertisers, who wish to publish drug advertisements in other localities, shall bring the drug examination and approval certificate, as issued by the public health department of the place of production, to the new advertising-targeted locality to exchange for their approval document.
Advertisers shall submit drug advertising applications to drug advertisements examination and approval departments, file the drug advertisement examination and approval form, and submit the following supporting documents:
1) A duplicate copy of the business license held by the advertisement applicant and by the drug producer;
2) A duplicate copy of the official permit of drug producing enterprise, or the official permit of drug dealer;
3) The official permit for drug production, the standards of drug quality, specifications and packaging
4) Trade mark registration document of drugs, or other documents issued to prove the drugs' registration status by the Trade Mark Department under the State Administration of Industry and Trade;
5) The examination and approval document issued by the State Council public health administrative department for drugs bearing specific trade names;
6) Other certificates as required by laws and regulations to prove the authenticity of the advertisements' content.
Advertisers, applying for publication of drug advertisements abroad, shall submit application to the State Council public health administrative department, file the drug advertisement examination form, along with the following documents and their Chinese translations:
1) A duplicate copy of the business license of the advertisement applicant as well as the drug producer;
2) The Registration Certificate of Imported Drug" which has been issued for the drug in question;
3) The standards of the drug's quality, specifications and packaging;
4) Other certificates which are required by laws and regulations to prove the authenticity of the advertisements' content.
Application for the examination and approval of overseas-produced drugs' advertisements, to be published in China, can be made through a domestic drug dealer or advertising agent.
The preliminary examination and approval of drug advertisements shall be conducted as follows:
The departments in charge of the examination of drug advertisement shall check the authenticity, validity, legality, and integrity of certificates submitted by the applicant and examine the authenticity and legality of the advertisements' manuscript. It should make decision on the preliminary examination, within 10 days after accepting the application, and issue the Notice on Decision of the Preliminary Examination to the applicant.
The final examination and approval of drug advertisements shall be conducted as follows:
Having passed the preliminary examination, an applicant should summit the decision notice of preliminary examination together with the advertisement itself to the original advertisement examination department. The department should make a decision on final examination within 10 days after accepting the application. For those applicants which passing the final examination, the department should issue the Examination Form of Drug Advertisement and the approval number of the advertisement examination. And it should explain to applicants, who have failed to pass the examination, on the reason why their applications were not approved.
An applicant can directly apply for the final examination and the advertisement examination department should make decision on it within 10 days after accepting the application.
The Notice of Decision on the Preliminary Examination of Drug Advertisement, and the Examination Form of Drug Advertisement, shall be signed by a competent official of the advertisement examination department and stamped with the official seal of the drug advertisement examination and approval department.
The advertising examination department shall send the Examination Form of Drug Advertisement, which has been approved in the final examination, to the advertisement supervision department of the same level for record.
The effective term of an approval certificate of drug advertisements is one year. For renewal of the approval, applications shall be submitted to the original examination and approval department two months before the expiry of the one-year term.
If an approved advertisement is involved in any of the following cases, the examination department should recall the ads for re-examination. The use of such advertisement shall be suspended during the re-examination:
1) When the condition, on which the examination was based, has changed;
2) When the State Council public health administrative department considers the approval of the advertisement by a provincial-level examination department as inappropriate;
3) When advertisement supervision departments suggest a re-examination;
4) Other situations that make the advertisement examination and approval department consider it necessary to recall the advertisement for reexamination.
An examination department should revoke the Examination Form of Drug Advertisement and cancel the approval certificate if the approved advertisement is involved in any of the following cases:
1) When new malfunction of the advertised drug is discovered in clinic practice;
2) When the official permit or business license of the drug producer or the drug dealer involved has been revoked by the authorities;
3) When the drug has been deprived of its production certificate;
4) When the contents of the drug advertisement extend beyond the scope as approved by the examination department;
5) When the drugs are listed by the State as obsolete and shall be discarded;
6) When the drug advertisement does not pass the re-examination;
7) When the public health department considers the advertisement as inappropriate for publication;
8) When the drug advertiser is under investigation by the advertisement supervision department.
Drug advertisement, whose contents need revision or the quality standard of the drug involved has changed, shall be sent to the advertisement administrative department for re-examination and approval.
An advertisement examination department shall submit the decision on revoking an approval certificate to the advertisement supervision department of the same level for reference.
Where the drug advertisement examination and approval department has discovered that a drug advertisement has been published without obtaining official approval or approval certificate, or the advertisement's contents have gone beyond its approved scope, the department shall file a notification on illegal drug advertisement" and request the advertisement supervision department of the same level to investigate into and take action on the case, while notifying the examination and approval department on its findings and decision on the case.
The registered number of approval certificate for drug advertisement and approval certificate for drug production shall be listed in the drug advertisement in question and published simultaneously.
The drug advertisement agent shall design and make advertisements of drugs, for which applications have been filed for preliminary examination and approval, in accordance with the contents specified in the Notice of Decision on Preliminary Examination issued by the examination and approval department.
Before running an advertisement, advertisement publishers shall first check the Examination Form of Drug Advertisements to verify the contents of such advertisement. The examination form should be the original document or its duplicate stamped by its original examination department, to be kept for one year. Advertisements shall not be published without official approval.
Advertiser of non-drug products, which advertises the products' efficacy in treating disease, shall be considered as advertising fake drugs and punished, in accordance with Article 41 of the Advertisement Law of the People's Republic of China, by the advertisement supervision department.
Those who published drug advertisements, in violation of these Measures or the Drug Advertisement Examination and Approval Standards, shall be punished in accordance with the relevant regulations of the Advertisement Law of the People's Republic of China, and the Drug Management Law of the People's Republic of China.
Advertisement examination and approval department, which violates principles of advertisement examination, approves illegal advertisement and allows it publication, shall be reported by the State advertisement supervision departments to the State Council public health administrative department and shall be dealt with according to Article 45 of the Advertisements Law of the People's Republic of China.
These Measures come into effect as of the date of promulgation.