The Chinese government recently released the final detailed reorganisation plan of the China Food and Drug Administration (‘CFDA’). Under the plan, the status of the existing State Food and Drug Administration (‘SFDA’) is elevated to ministerial level, reporting directly to the State Council, which is China’s highest administrative body. The CFDA will replace a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States.

Need for change

China’s State Drug Administration (‘SDA’) was established in 1998 with the aim of creating a centralised drug administration, supervised by The State Council. In 2003 the SDA was reorganised into the SFDA and its remit broadened to oversee the regulation of drugs, food and cosmetics, under the supervision of the State Council.

In 2008 the agency was somewhat downgraded when following a series of corruption scandals involving several SFDA officials, it was removed from State Council control and instead affiliated to the Ministry of Health. Following the 2008 reorganisation, the agency has increasingly become viewed to be highly fragmented.

Several commentators have observed that a number of departments are now focusing too much on micro issues and that an overlapping in some agency functions has sometimes led to supervision loopholes. A key driver for the latest reorganisation has been the fragmented structure of the departments overseeing food safety and regulation.

Reshaping China’s food regulatory environment

China's former food safety system involved at least five departments, including health, agriculture, quality supervision, industry and commerce administration, and food and drug supervision. Insufficient communication and coordination among these agencies has often resulted in low work efficiency. Furthermore, a series of food safety scandals have impacted upon consumer confidence.

New structure and responsibilities

With this information to hand, during the First Session of the Twelfth National People’s Congress the Chinese government made the decision to reorganise and elevate the position of the SFDA to ministerial level.

Chen Xiaohong, Vice-minister of Health and a member of the Chinese People's Political Consultative Conference has commented, "the restructuring will better facilitate the enforcement of the food safety laws and regulations and improve the safety of the nation's food and drugs."

The recently announced changes will mostly affect food regulation in China. The preliminary plan is to combine the functions of the existing State Council’s Food Safety Office, the SFDA as well as the food supervision duties from the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the State Administration for Industry and Commerce (SAIC).

The CFDA will be responsible for supervising food and drug safety in the process of production, circulation and consumption. 13 departments are to be separated from their former departments, 1 new department is established and 3 departments will remain.

Duties to be now handled by the CFDA:

  • Pharmacopoeia codification
  • Determination of accreditation conditions for food safety inspections and development of standards
  • Compulsory codification of medical devices
  • Cosmetics manufacturing certification and mandatory inspections

The following duties are to be integrated:  

  • Drug manufacturing certification and GMP certification
  • Drug Supply certification and GSP certification
  • Cosmetics Manufacturing certification and Cosmetics Hygiene licensing

The following duties are to be handled by local FDAs:  

  • Drug manufacturing certification and GMP certification
  • Re-registration of drugs
  • Changing approval of domestic class III medical device registration
  • Applications for contract drug manufacturing

Main responsibilities emphasised

Compared with the previous reorganisation plan of 2008, the current proposal retains the CFDA’s responsibilities of supervising and regulating drugs, medical devices, food and cosmetics. In addition, the following responsibilities are emphasised:

  • The development of the provisions for food administrative licensing and the supervision of its implementation
  • The establishment of a safety and supervision reporting system
  • The development of the provisions for cosmetic supervision and the supervision of its implementation

Future implications

The additional authority gained by the new agency by way of its promotion within China's government to a ministerial agency may boost its ability to negotiate additional resources and authority to pursue counterfeiters and other quality concerns that have plagued the pharmaceutical industry in recent years.

Furthermore, a boost in regulatory capacity would be a welcome change for the industry, which has long complained about the lengthy and sometimes confusing regulatory processes and timelines. The CFDA looks set to focus on the more significant regulatory issues. Maybe operational efficiencies are set to improve, now that certain administrative functions have been delegated down to the local FDAs and resources increased?