Measures for the Inspection of Drug Advertisements

Measures for the Inspection of Drug Advertisements

Order of the State Food and Drug Administration and the State Administration for Industry and Commerce [2007] No. 27

March 13, 2007

The Measures for the Inspection of Drug Advertisements were formulated and adopted by the State Food and Drug Administration (SFDA) and the State Administration for Industry and Commerce (SAIC) of the People's Republic of China They are hereby promulgated in sequence with a SFDA order number, and are effective as of May 1, 2007.
Director of the State Administration of Food and Drugs: Shao Mingli
Director of the State Administration of Industry and Commerce: Zhou Bohua

Measures for the Inspection of Drug Advertisements
　
Article 1 According to the Advertising Law of the People's Republic of China (hereinafter referred to as the Advertising Law), the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), the Implementing Regulations of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law Implementation Rules) and other related state provisions on the supervision and administration of adverts and drugs, the present Measures are enacted with a view to strengthening the administration of drug advertisements (hereinafter referred to as drug adverts) and guaranteeing the authenticity and legality of drug adverts.
　
Article 2 All adverts containing drug names, diseases to which the drugs are applicable (functions and indications) or other drug-related content, that are published through various media or in various drug advertisement forms shall be inspected according to the present Measures.
With regard to non-prescription drug adverts that only publicize the drug name (including the general name and brand name) or a prescription drug advert that only publicizes the name of the drug (including the general name and brand name) on designated professional publications of medicine science and pharmacy, an inspection is not required.
　
Article 3 The drug advert under inspection may not be accepted unless it complies with the following laws, regulations and related provisions:
1. the Advertising Law;
2. the Drug Administration Law;
3. the Drug Administration Law Implementation Rules;
4. Standards for the Examination and Release of Drug Advertisements;
5. Other state provisions on administrating adverts.
　
Article 4 The Drug Administrative Departments of Provinces, Autonomous Regions and Municipalities directly under the Central Government shall be the drug advert inspection bodies and shall, within their respective administrative regions, take charge of inspecting drug adverts. The administrative Departments of Industry and Commerce at or above county level shall be the drug advertising supervisory and administrative bodies.
　
Article 5 SFDA shall conduct guidance and supervision over the drug advert inspection work as carried out by the drug advert inspection bodies, and shall, according to law, exact punishment on any inspection bodies that violates the present Measures.
　
Article 6 Only a qualified company that manufactures or trades a drug may file an application for a drug license number. In the case of a trading enterprise filing such an application, the consent of the manufacturing enterprise must be obtained.
An applicant may entrust an agent to deal with the application process for a drug advert license on its behalf.
　
Article 7 An application for a drug advert license shall be filed with the drug advert inspection body of the locality of the drug's manufacturer.
　　......