China SAMR 3 Stipulation Scheme Unveiled

Takehome:

• 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 cosmetics.
• 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. The scheme also underlines that both CNCA and SAC (Standardization Administration of China) are now under the jurisdiction of SAMR.

In addition, "3 stipulations scheme" of State Drug Administration (A subordinate institution of SAMR) mentions that a “cosmetic safety supervision department” will be exclusively set up. An industry expert also points out that in the institutional reform at the provincial level, the cosmetics supervision department may also be exclusively set up.

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 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.

• 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:

• State Drug Administration is responsible for formulating cosmetic regulatory systems, as well as licensing, inspection and penalties for cosmetics research and manufacture. 
• SAMR should cooperate with Ministry of agriculture and rural affairs to establish mechanisms related to origin exit market access and traceability.
• National Health Commission (NHC) should give timely feedback on results of risk assessment studies to SAMR to guide policy.
• 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 cosmetics.