Latest Reform of China’s Drugs, Medical Devices, Cosmetics and Food Regulatory System

On March 10, 2013, the State Counsel of China released the Program of Structural Reform and Function Transformation of the State Counsel’s Functional Organs (“Program”) (《国务院机构改革和职能转变方案》), deciding, among other issues, to reorganize the State Food and Drug Administration (“SFDA”) with the aim of integrating and strengthening the administration and supervision of food (including health food), drugs, medical devices and cosmetics.  The reorganized SFDA, according to the Rules on the CFDA’s Main Responsibilities, Internal Departments and Staff Organization (《国家食品药品监督管理总局主要职责内设机构和人员编制规定》) issued on March 31, 2013, has been named to the China Food and Drug Administration (“CFDA”) comprising of 17 functional departments (see attached table). 

The CFDA takes some responsibilities from other authorities, delists several matters from the list of matters subject to its administrative approval, and delegates its certain approval authority to its local counterparts. The major changes with respect to administration and supervision of drugs, medical devices, cosmetics and food are listed below:

• Drugs

1. The procedures of examination and approval required for manufacture of drugs and grant of Good Manufacturing Practices (“GMP”) certification will gradually be combined into a single examination and approval procedure;

2. The procedures of examination and approval required for supply of drugs and grant of Good Supply Practices (“GSP”) certification will gradually be combined into a single examination and approval procedure;

3. The food and drug administrations at provincial level take the responsibilities of the original SFDA for the quality management authentication;

4. The food and drug administrations at provincial level take the responsibilities of the original SFDA for examination and approval of the renewal of drug registration as well as the supplemental application which does not change the quality of drugs;

5. The food and drug administrations at provincial level take the responsibilities of the original SFDA for examination and approval of the OEM manufacture of drugs;

6. The responsibilities for the continuing education of licensed pharmacist are transferred to the China Licensed Pharmacist Association; and

7. The CFDA takes the responsibilities of the original Ministry of Health (will be known as National Health and Family Planning Commission according to the Program) for drug legislation.

• Medical Devices

1. The food and drug administrations at provincial level take the responsibilities of the original SFDA for the quality management authentication;

2. The food and drug administrations at provincial level take the responsibilities of the original SFDA for examination and approval of the alteration application (with the quality of medical devices not to be changed) for domestic-made medical devices (Class Ⅲ); and

3. The CFDA takes the responsibilities of the General Administration of Quality Supervision, Inspection and Quarantine (“AQSIQ”) for compulsory certification of medical devices, as a part of the medical device registration process.

• Cosmetics

1. The procedures of examination and approval required for manufacture of cosmetics and grant of hygiene certificate will be combined into a single examination and approval procedure;

2. The food and drug administrations at provincial level take the responsibilities of the original SFDA for examination and approval of import of non-special function cosmetics; and

3. The CFDA takes the responsibilities of the AQSIQ for examination and approval of manufacture and compulsory inspection of cosmetics;

• Food

1. The CFDA takes the responsibilities of the original Ministry of Health to decide the qualification of food safety inspection agencies and inspection specifications; and

2. The CFDA takes the responsibilities to coordinate food safety inspection agencies under supervision of the original SFDA and the AQSIQ, implement resource sharing and separate operation from administration. 

In addition to the CFDA reform summarized above, the National Health and Family Planning Commission, which administers the health care services and health care institutions, will release its reorganization plan at the end of April, 2013.  Further, the State Administration of Traditional Chinese Medicine, according to the Program, is under the supervision of the National Health and Family Planning Commission. The CFDA reform illustrates China’s strong determination to strengthen the CFDA’s power over the integrated drugs, medical devices, cosmetics and food regulatory system.