Third Draft of Advertising Measures of Health Food, FSMP, Medicines and Medical Devices under Consultation

On October 25, 2019, State Administration for Market Regulation (SAMR) published the third consultation draft of Administrative Measures on the Review of Health Food, FSMP, Drug and Medical Devices Advertisements and sought public opinion.^[1] Any feedback shall be submitted to SAMR prior to November 1 via one of the following approaches:

SAMR official website (http://www.samr.gov.cn );
Email to [email protected] with mail subject “《药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理办法（征求意见稿）》公开征集意见”(public feedback on Administrative Measures on the Review of Health Food, FSMP, Drug and Medical Devices Advertisements);
Or send by post to address “北京市西城区三里河东路8号（邮编100820）国家市场监督管理总局广告监管司”(Advertisement Supervision Department of SAMR, 8 East Sanlihe Road, Xicheng District, Beijing, Postcode 100820 )

Major Changes in Latest Consultation Draft

The third draft is divided into 6 chapters and contains 34 articles in total, detailing general principles, requirements and restrictions of content, aspects of review procedure, legal liability and supplementary articles. Despite slight changes to the layout or expression, major differences are:

Chapter	Changes
Chapter 2 Standard for ads review	[Article 5~8] Loosen restrictions on ads content by adding preconditions: When advertisement of medicine involves indications for use, major functions, pharmacological effects etc., it is limited to the information stipulated in product specification. When advertisement of medical device involves product name, application scope, function mechanism, structure and composition etc., it is limited to the information certified in product registration/filing certificate and product specification. When advertisement of health food involves health functions, efficacy ingredients and their concentration, suitable groups, dosage etc. it is limited to the information certified in product registration/filing certificate and product specification. When advertisement of food for special medical purposes involves suitable groups etc. it is limited to the information certified in product registration certificate and product specification.
	[Article 11] Add prohibition of misleading content: Advertisements involving effect promise, comparison with products of same kind, endorsement of celebrity, cure-all product, fake scientific support etc. are prohibited.
	[Article 12] Add prohibition of content leading to irrational consumption of the product.
Chapter 3 Procedure of ads review	[Article 20] Change advertisement period of validity: The length of validity term shall align with product registration/filing validity term or shall not exceed 5 years if product registration/filing certificate has no specific validity term.
	[Article 21] Change requirements for cancellation: Under specified circumstances, applicants shall proactively apply for cancellation of advertisement of relevant products.
	[Article 25] Cancel notification obligation of advertisement published elsewhere (not in the city where it is reviewed and approved)

Download the third consultation draft here.

Regulation development timeline

Nov. 2018	Symposium on the situation and problems associated with advertisements review
Nov. 2018	Notification No.2018-87 on review of relevant advertisements
Jan. ~Mar. 2019	Written into first level legislative plan
Jan. ~Mar. 2019	Sort out all regulations, administrative rules and normative documents relating to the advertisements
Mar. 13~ Apr. 12, 2019	First consultation period
Jun. 6~Jun. 26, 2019	Second consultation period
Oct. 25~Nov. 1, 2019	Third consultation period