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On June 6, 2019, State Administration for Market Regulation (SAMR) consulted on the Administrative Measures on the Review of Health Food, FSMP, Drug and Medical Devices Advertisements for the second time[1]. The first draft of the measures were open to public consultation on March 13th 2019.[2] That consultation period lasted for 30 days[3] during which 340 suggestions from both the public and industry were submitted to SAMR. SAMR revised the first draft based on that feedback focusing on important issues like: prominently displayed content, applicants’ qualification, supporting documents, period of validity and reassessment.
Regulation development timeline
| Nov. 2018 | Symposium on the situation and problems associated with advertisements review Notification No.2018-87 on review of relevant advertisements |
| Jan. ~Mar. 2019 | Written into first level legislative plan 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 |
Major Difference between Two Consultation Drafts
The second draft is divided into 5 chapters and contains 33 articles in total, detailing general principles, requirements and restrictions of content, aspects of review procedure, legal liability and supplementary articles. Major changes are:
| Differences | 1st consultation draft | 2nd consultation draft[4] |
| Application scope | Ads of health food, FSMP, drug and medical devices |
|
| Management of FSMP |
| (delete) |
| Management of IFSMP | Ads of Infant FSMP are not allowed to be published. | Advertising of Infant FSMP through mass media or in public places is forbidden. |
| Acceptance of application documents | If application documents do not meet requirements, competent authorities should inform the applicant/agent of all the problems at one time or separately but within 5 working days. | If application documents do not meet requirements, competent authorities should inform the applicant/agent of all the problems at one time. |
| Publication of approved ads | Publish the information of compliant ads to the public within 7 working days. | Publish the information of compliant ads to the public within 3 working days, including approval No., applicant, content, validity period, ads category, product name, product registration/filing number etc. |
| Period of validity | Approval number will be valid for 1 year | The length of validity term is determined by the applicant, but shall not exceed the product registration/filing validity term or shall not exceed 5 years if product registration/filing certificate has no specific validity term. |
| Reassessment | Competent authorities are entitled to reassess approved ads when necessary… | (delete) |
| Exemption | If ads meet the following criteria, they are exempted from review:
| (delete) |
The noteworthy thing in the second consultation draft is that it slightly loosens restriction on advertising of infant FSMP and gives applicants the flexibility to fix the validity term of ads.
Any comments should be submitted to SAMR prior to June 26, 2019. Contact info:
Email: [email protected]
Fax: 010-68050321
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