Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose
Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose
Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose
Order of the State Administration for Market Regulation No. 21
December 24, 2019
The Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose, which were deliberated and adopted on December 13, 2019 at the 16th executive meeting of the State Administration for Market Regulation in 2019, are hereby issued and shall come into effect as of March 1, 2020.
Xiao Yaqing, Director
Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose
(Issued on December 24, 2019 as the Order of the State Administration for Market Regulation No. 21)
Article 1 These Measures are formulated in accordance with the Advertising Law of the People's Republic of China and other laws and administrative regulations with a view to strengthening the supervision and administration of advertisements for drugs, medical devices, dietary supplements and foods for special medical purpose, regulating the advertising review, safeguarding the order of the advertising market, and protecting the legitimate rights and interests of consumers.
Article 2 These Measures shall apply to the advertising review for drugs, medical devices, dietary supplements and foods for special medical purpose.
No advertisement for any drug, medical device, dietary supplement or food for special medical purpose may be published without review.
Article 3 Advertisements for drugs, medical devices, dietary supplements and foods for special medical purpose shall be authentic and legal, and shall not contain any false or misleading content.
Advertisers shall be responsible for the authenticity and legality of their advertisements for drugs, medical devices, dietary supplements and foods for special medical purpose.
Article 4 The State Administration for Market Regulation ("SAMR") shall be responsible for organizing and guiding the advertising review for drugs, medical devices, dietary supplements and foods for special medical purpose.
Departments for market regulation and medical products administrations (hereinafter referred to as "advertising review authority" or "advertising review authorities") of each and all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the advertising review for drugs, medical devices, dietary supplements and foods for special medical purpose and may legally entrust other administrative authorities with specifically carrying out advertising review.
Article 5 The contents of a drug advertisement shall be subject to the instructions approved by the medical products administration under the State Council. If a drug advertisement involves the name, indications, main functions, pharmacological action, or other content of the drug concerned, it shall not go beyond the scope of the instructions.
Drug advertisements shall prominently indicate contraindications and adverse reactions concerned. Advertisements for prescription drugs shall further be prominently marked with the words "THIS ADVERTISEMENT IS FOR MEDICAL AND PHARMACEUTICAL PROFESSIONALS TO READ ONLY", and those for over-the-counter (OTC) drugs shall further be prominently marked with the logo for OTC drugs and the words "PLEASE BUY AND USE FOLLOWING THE DRUG INSTRUCTIONS OR UNDER THE GUIDANCE OF PHARMACISTS".
Article 6 The contents of a medical device advertisement shall be subject to those of the registration certificate or record-filing certificate approved by, or the product instructions registered by or filed with the competent medical products administration. If a medical device advertisement involves the name, scope of application, mechanism of action, structure and ingredients, or other content of the medical device concerned, it shall not go beyond the scope of the registration certificate or record-filing certificate, or the registered or filed product instructions.
Advertisements for medical devices which are recommended for personal use shall prominently indicate the words "PLEASE READ THE PRODUCT INSTRUCTIONS CAREFULLY OR BUY AND USE UNDER THE GUIDANCE OF MEDICAL PERSONNEL". In case of contraindications or precautions in the registration certificate of a medical device, the advertisement shall prominently indicate the words "DETAILED CONTRAINDICATIONS AND PRECAUTIONS CAN BE FOUND IN THE INSTRUCTIONS".
Article 7 The contents of a dietary supplement advertisement shall be subject to those of the registration certificate or record-filing certificate approved by, or the product instructions registered by or filed with the competent department for market regulation, and shall not involve disease prevention or treatment functions.
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Order of the State Administration for Market Regulation No. 21
December 24, 2019
The Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose, which were deliberated and adopted on December 13, 2019 at the 16th executive meeting of the State Administration for Market Regulation in 2019, are hereby issued and shall come into effect as of March 1, 2020.
Xiao Yaqing, Director
Interim Measures for the Administration of Advertising Review for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose
(Issued on December 24, 2019 as the Order of the State Administration for Market Regulation No. 21)
Article 1 These Measures are formulated in accordance with the Advertising Law of the People's Republic of China and other laws and administrative regulations with a view to strengthening the supervision and administration of advertisements for drugs, medical devices, dietary supplements and foods for special medical purpose, regulating the advertising review, safeguarding the order of the advertising market, and protecting the legitimate rights and interests of consumers.
Article 2 These Measures shall apply to the advertising review for drugs, medical devices, dietary supplements and foods for special medical purpose.
No advertisement for any drug, medical device, dietary supplement or food for special medical purpose may be published without review.
Article 3 Advertisements for drugs, medical devices, dietary supplements and foods for special medical purpose shall be authentic and legal, and shall not contain any false or misleading content.
Advertisers shall be responsible for the authenticity and legality of their advertisements for drugs, medical devices, dietary supplements and foods for special medical purpose.
Article 4 The State Administration for Market Regulation ("SAMR") shall be responsible for organizing and guiding the advertising review for drugs, medical devices, dietary supplements and foods for special medical purpose.
Departments for market regulation and medical products administrations (hereinafter referred to as "advertising review authority" or "advertising review authorities") of each and all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the advertising review for drugs, medical devices, dietary supplements and foods for special medical purpose and may legally entrust other administrative authorities with specifically carrying out advertising review.
Article 5 The contents of a drug advertisement shall be subject to the instructions approved by the medical products administration under the State Council. If a drug advertisement involves the name, indications, main functions, pharmacological action, or other content of the drug concerned, it shall not go beyond the scope of the instructions.
Drug advertisements shall prominently indicate contraindications and adverse reactions concerned. Advertisements for prescription drugs shall further be prominently marked with the words "THIS ADVERTISEMENT IS FOR MEDICAL AND PHARMACEUTICAL PROFESSIONALS TO READ ONLY", and those for over-the-counter (OTC) drugs shall further be prominently marked with the logo for OTC drugs and the words "PLEASE BUY AND USE FOLLOWING THE DRUG INSTRUCTIONS OR UNDER THE GUIDANCE OF PHARMACISTS".
Article 6 The contents of a medical device advertisement shall be subject to those of the registration certificate or record-filing certificate approved by, or the product instructions registered by or filed with the competent medical products administration. If a medical device advertisement involves the name, scope of application, mechanism of action, structure and ingredients, or other content of the medical device concerned, it shall not go beyond the scope of the registration certificate or record-filing certificate, or the registered or filed product instructions.
Advertisements for medical devices which are recommended for personal use shall prominently indicate the words "PLEASE READ THE PRODUCT INSTRUCTIONS CAREFULLY OR BUY AND USE UNDER THE GUIDANCE OF MEDICAL PERSONNEL". In case of contraindications or precautions in the registration certificate of a medical device, the advertisement shall prominently indicate the words "DETAILED CONTRAINDICATIONS AND PRECAUTIONS CAN BE FOUND IN THE INSTRUCTIONS".
Article 7 The contents of a dietary supplement advertisement shall be subject to those of the registration certificate or record-filing certificate approved by, or the product instructions registered by or filed with the competent department for market regulation, and shall not involve disease prevention or treatment functions.
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