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China SAMR 3 Stipulation Scheme Unveiled

In general, SAMR takes overall charge of market supervision (food, cosmetics, pharmaceuticals, medical devices, Chinese medicine). SAMR is responsible for all work previously undertaken by CFDA including policy drafting and supervision of special food. CNCA and SAC are now under the governance of SAMR. The scheme also highlights the significance of cooperation with other national authorities, such as NHC and GAC.

4 months after the formation of the State Administration for Market Regulation (SAMR), its “3 stipulations scheme” has been finalized and released. The scheme details the new regulatory authority’s organizational structure, staffing and functions, and it also underlines that both CNCA and SAC (Standardization Administration of China) are now under the jurisdiction of SAMR.

SAMR consists of 27 subordinate departments, 5 of which are majorly tasked with food administration. "Food safety inspection and monitoring department" is newly established, highlighting the significance of sampling inspection in following food supervision work.  A “special food safety supervision department” is exclusively set up to undertake drafting of special food filing/registration policy. Based on this, it is expected that the infant formula registration application assessment rate will return to pre-march 2018 levels now. Besides, it suggests that the in-process and post supervision on special food will be given priority in future as its title has changed from "registration management department" to "safety supervision department".

SAMR major responsibilities include:

  • Market management

SAMR is responsible for development, oversight and enforcement of regulation, policy and standards related to market supervision. It will also develop food safety and standardization strategies to create an honest and fair market environment.

  • Market entity registration

It is responsible for registration of market entities conducting business in China, including representative office of overseas enterprises.

  • Quality and safety supervision

SAMR will carry out risk monitoring on product quality and safety, as well as implement national sampling inspection across the country.

  • Comprehensive coordination of food safety management

SMAR develops and enforces significant food safety policy. It is obliged to construct a food safety emergency system and act as primary agent in the resolution and investigation of any food safety incidents. Besides, it also takes on the routine work of the State Council Food Safety Commission.

  • Food safety supervision

SAMR will be responsible for food sampling inspection, risk monitoring and risk alert. It is tasked with optimizing China’s food safety traceability system as well as registration/filing and supervision on special food.

  • Standardization work

SAMR is obliged to notify new GB standards to the public and draft GB/T standards.

In addition, SAMR should coordinate with other ministries to optimize market supervision with major interactions summarized below:

  • SAMR should cooperate with Ministry of agriculture and rural affairs to establish mechanisms related to origin exit (means the agriculture products are qualified to leave the orgin) market access and traceability.

  • National Health Commission (NHC) should give timely feedback on results of risk assessment studies to SAMR to guide policy. In turn, SAMR can also instruct NHC to develop food safety risk assessment targeting specific areas.

  • An information sharing system should be set up between SAMR and GAC to avoid redundancy and overlap of administrative duties and to aid in information dissemination related to safety and quality issues associated with import/export activities.  

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