The first part of this publication outlined the internal restructuring of the Chinese Food and Drug Administration. Following on from this, part two outlines the most significant changes to interministerial regulatory territories and the most important changes to their working relationships, it also illustrates the fundamental differences between the current regulatory network and that of it's predecessor. The most notable changes illustrated below are the integration of the MOH and NPFPC into the NHFPC and the elevation of the CFDA to Ministerial level.In order to promote a clear chain of command and division of labor the CFDA has undertaken a number of responsibilities previously designated to other ministries.
Historical Main Regulatory Hierarchy
Current Main Regulatory Hierarchy:
Taking the past and current ministries individually, the following sections will outline the most significant regulatory changes and focus on the new responsibilities and remit of the CFDA.
Ministry of Health (MOH): Announced during the 12th Nationals People’s congress this March, a major part of the China’s recent institutional reform was to abolish the former Ministry of Health and National Population and Family Planning Commission (NPFPC) and to integrate the individual responsibilities of both into the newly formed National Health and Family Planning Commission (NHFPC). After this a large proportion of the responsibilities previously designated to the MOH were transferred to the CFDA.
Listed below are the functions previously designated to the MOH now designated to the CFDA.
The CFDA is now responsible for:
- Drafting regulations or provisions for food (including food additives and health food) safety;
- Formulating measures on the administrative licensing of food
- Accrediting food safety testing institution
- Participating in formulation of Chinese Pharmacopoeia and National Essential Drug List together with NHFPC
AQSIQ: Listed below are the functions previously designated to the AQSIQ now designated to the CFDA.
The CFDA is now responsible for:
- Cosmetic production administrative licensing and compulsory inspection
- Medical Equipment Licensing and certification
The AQSIQ will however retain its supervisory role with respect to import and export of foodstuffs. AQSIQ will also ensure that food packaging materials, food production equipment and machinery and food containers all meet national standards.
Ministry of Agriculture (MOA): The relationship between the CFDA and the MOA will remain the same. The respective scope of the two ministries can be divided as follows. The MOA is responsible for all pre-production farming inputs such as crop and animal husbandry, raw milk quality etc., whereas the CFDA is responsible for post-production outputs of the previous processes.
NHFPC:The primary duties assigned to the NHFPC will orientate around food safety risk assessment and formulate national food safety standards. It will in close coordination with the CFDA undertake a vital role in formulating the national pharmacopeia and developing the food safety monitoring plan
State Administration for Industry & Commerce (SAIC): In conjunction with the CFDA will regulate advertising of drugs, medical devices and health foods.The SAIC will be responsible for monitoring the advertising promotion activities while the CFDA is concentrated on examining the contents, such as functional claims, in ads for drugs, medical devices and health food,
Whilst sweeping changes have already been implemented and numerous more are on the cards, the implications for the indigenous and foreign enterprise operating within the Chinese food, cosmetic, pharmaceutical and Medical device industry cannot be understated. What is certain however is that in the current climate of rapid change, enterprise, particulary foreign enterprise will need all tools at their disposal to stay abreast of the latest developments.