The Chinese government recently published the final plan to restructure its food, drug and medical device regulatory agency, now named the China Food and Drug Administration (“CFDA”), defining the boundary of its authority and its collaboration with peer agencies in the central government.
Some restructuring measures in the plan will significantly shape the regulatory landscape of the drug and medical device industries in China:
- CFDA will take steps to simplify some of its existing administrative licensing requirements for local drug manufacturers and distributors. For local drug manufacturers, the drug manufacturing license and the Good Manufacturing Practice (GMP) requirement will soon be merged into one certification; for local distributors, the drug distribution license and the Good Supply Practice (GSP) certification will also be trimmed down to one license.
- CFDA will delegate some of its approval authority to its provincial counterparts. GMP certification for local drug and device manufacturers, approval for local drug contract manufacturing, approvals for drug re-registration, non-substantial changes in an existing drug registration, as well as non-substantial changes in local Class III products will soon be conducted by over 30 provincial FDAs.
- Some powers previously held by other agencies will be assigned to CFDA, including compulsory certification of medical devices and compulsory inspection of cosmetics products, both of which are currently conducted by Administration for Quality Supervision Inspection and Quarantine (“AQSIQ”). As a result of the restructuring, the compulsory certification on certain medical device will be consolidated into the medical device registration process at CFDA.
In addition to those restructuring measures concerning drugs and devices, authorities in regulating food manufacturing and distribution regulatory authority will be consolidated in CFDA from AQSIQ and others; CFDA will, however, continue to collaborate with other peer agencies in ensuring food safety:
- It will assist and advise the National Commission for Public Health and Family Planning, which will be in charge of developing national food safety standards and conduct food safety risk evaluations;
- It will collaborate with AQSIQ to identify food safety issues, as AQSIQ will continue regulating the manufacturing of food packaging materials, food containers, and other food- related products;
- It will establish a food safety traceability and coordination mechanism with the Ministry of Agriculture (MOA) for agricultural products once they enter into the market.