Chinese food and drug administration is currently undergoing a drastic makeover. This sea change is being spearhead by the CFDA which has recently been elevated to a ministerial level institution affording it greater regulatory clout.The remodeling aims to increase overall efficiency by reducing the bureaucratic redundancy and regulatory overlap which hampered the functioning of its predecessor. The CFDA is implementing a three pronged approach to deal with the most obvious dysfunction. Broadly speaking it will scrap or integrate functions deemed sufficiently similar or constituting a high degree of overlap, it will take on new duties and also delegate duties previously assigned to it to more appropriate institutions.Another key aim is to implement a vertical management strategy with quality assurance and safety supervision integrated throughout all stages of production and market release thereby fostering a self-regulating food and pharmaceutical industry. Following from this greater punitive and enforcement powers are to be granted to the CFDA, equipping the industry watchdog with the teeth it previously lacked ensuring that its bite will now be worse than its bark. Commercial enterprises and NGO testing institutions will also play a greater role, reflecting the Government’s plan to increase the effect that market forces have on the regulatory landscape and the future development of the food, pharmaceutical, medical and cosmetics industry.
On May 15th the CFDA issued an announcement elaborating on the specifics of this transformation. The scope of this can again be broadly categorized as internal changes involving the restructuring and reorganization of the CFDA and external changes involving its new relationship and duties with other Ministries and institutions. For the sake of clarity the subjects will be divided into two separate articles:
Part 1 will deal with the most significant internal structural and organizational changes, along with some of the changes in operations and functions; and
Part 2 will deal with the major duties taken over by the CFDA formerly assigned to different ministries and institutions along with assessing the major implications for the relevant industries.
CFDA Internal Organization
The CFDA restructuring and new administrative framework has divided the CFDA into 17 distinct departments with a clearly defined role for each, below is a brief overview of each department:
General Office: Day to day running of the office
Secretary (Policy research) – Oversight duties relating to food safety supervision and management.
Legal division – Deals with all legal issues relating to the administrative oversight of criminal prosecutions relating to foods, cosmetics, drugs etc. Oversight on drafting of standards.
Food safety Supervision- (Production emphasis) - Oversight duties tasked with ensuring adherence to national standards at provincial level.
Food safety supervision 2- Consumer emphasis. This department is tasked with ensuring effective distribution and circulation of foodstuffs.
Food safety division 3- Statistical analysis of food safety trends and forecast of demands. Organize food safety early warning and risk management system. Involved in development of risk assessment monitoring system.
Drug and Cosmetic registration Management division- Ensure all licensing and manufacture standards are adhered to. Optimize registration system.
Medical Device registration system Ensure all licensing and manufacture standards are adhered to. Optimize registration system.
Drug and Cosmetic supervision - Regulatory oversight duties to ensure all standards are adhered to. Adverse drug reactions and event reporting and monitoring. Ensure no illicit use or production of controlled substances.
Medical Device Supervision Department –Regulatory oversight duties to ensure all standards are adhered to. Adverse drug reactions and event reporting and monitoring.
Inspection bureau- This department will deal with major food and drug regulatory violations. It will standardize the administrative enforcement response to violations. This department has oversight duties involving product recall and disposal.
Emergency Management Division – Formulate emergency response plan to major events and conduct drills.
Technology and Standards Department – Promote technological advancements in all areas related to the food industry such as electronic monitoring and tracking systems. Development of scientifically robust testing methodologies and criteria.
News and Publicity Department – Disseminate food safety issues and changes to the public.
Personnel division – Responsible for all HR duties and training of staff. Improve the licensed pharmacist qualification system and supervise licensed pharmacist registration
Planning and Finance – Responsible for budgeting and internal auditing.
International cooperation department (Including Taiwan, Hong Kong and Taiwan) – Promote and manage international cooperation.
Increasing productivity and decreasing regulatory overlap
The primary aim here is to diminish administrative workload by combining licensing and certifications into a single certificate. This will affect the following areas.
Integrating pharmaceutical production licensing and pharmaceutical good manufacturing practice (GMP) certification
Combining pharmaceutical operating licensing and pharmaceutical good supply practice (GSP) certification
Combining cosmetics production licensing and cosmetics health licensing
Assigning the responsibility of continuous education of licensed pharmacists to the China Licensed Pharmacist Association.
Delegation of duties
The CFDA will reassign quality supervisory roles to provincial level institutions and oversee the process rather than directly carry out this function. This will affect the production and supervision of drugs, medical devices and imported non-special use cosmetics.
In the next article the topic will be discussed dealing with the external changes particularly relating to the functions previously designated to the Ministry of Health, AQSIQ and workload sharing with NHFPC which has also been recently elevated to a ministerial level institution.
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