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On Apr. 10, 2018, State Administration for Market Regulation was formally recognized in Beijing. Later that afternoon, it made its first major announcement detailing reform plans and outlining new plans regarding supervision of drugs, foods, cosmetics etc.
State Administration for Market Regulation is responsible for overall market supervision of numerous pre-packaged finished products and associated raw materials (read CL news here). Until practical implementation of the new regulatory systems introduced by the "3 stipulations scheme" are finalized the previous regulatory requirements stipulated by CFDA, AQSIQ, NHFPC regulations are applicable including:
The filing/registration approval and inspection of food, drug, medical devices, cosmetics, health food, infant formula, food for special medical purposes still follow the previous rules
The format of documents remains the same;
The application procedure will not change now.
Zhang Mao, the head of State Administration for Market Regulation, said in a conference that the new "3 stipulations scheme" will be completed by Jun. 20, 2018. The schedule for the institutional restructuring is:
By 3.31—leader appointment of State Administration for Market Regulation
By 4.10—inauguration
By 5.31—submit the draft of “3 stipulations scheme”
By 6.20—approval of new “3 stipulations scheme”
By the end of September—new scheme implementation
By the end of 2018—evaluation
We can expect detailed policies and corresponding changes in market access requirements to begin after the approval and subsequent implementation of the "3 stipulations scheme" (late 2018). Regarding the influence of departmental restructuring, Professor Liu Peng of Renmin University of China said it would not have substantial impact on filing/registration of special food and also suggested that enterprises should follow previous requirements and continue compliance work.
Major institutional reform has already been realized since the end of the recent two sessions of the 13th NPC. The new competent authorities involved in the food supply chain have already been formally recognized, and their official websites have also been updated:
National Health Commission: http://www.moh.gov.cn/zhuz/index.shtml
State Administration for Market Regulation: http://samr.saic.gov.cn/
Ministry of Agriculture and Rural Affairs: http://www.moa.gov.cn/
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