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CFDA Reform - A New Food and Drug Regulator in China

Dawn (Dan) Zhang
Greenberg Traurig, LLP - Shanghai Office

July 23, 2013

Previously published on July 17, 2013

To deepen government reform and improve government efficiency and transparency, the State Council of the People's Republic of China recently released the Plan for Government Institutional Reform and Function Change (the Restructuring Plan), which was approved by the People’s Congress at its first session. Taking effect on March 14th, 2013, this Restructuring Plan focused on restructuring the institutional framework, integration and perfection of government functions at the central level. The implications of such a restructuring would range far and wide, and would fundamentally change the landscape of China's governmental system as it comes into reality.

In the food and drug section, according to the Restructuring Plan, the former State Administration of Food and Drugs (SAFD) has been elevated to the ministry level, and is now renamed as China Food and Drugs Administration (CFDA). On April 10th, 2013, the PRC State Council further extended the reform to the local level and promulgated the Guiding Opinions on the Reform and Improvement of Food and Drug Administration Systems by Local Governments (the Opinions). Two months later, on May 16th, 2013 the newly-branded CFDA released a detailed plan on internal organizations and staff, as well as transformation of functions (the Plan). All of these efforts are suggesting that the Chinese government is paying more attention to the food and drug safety issues.

After this round of reform, the newly established CFDA absorbed 1) all the responsibilities and powers of the former Office of National Food Safety Committee and the former SAFD, 2) the responsibilities and powers previously assumed by the General Administration of Quality Supervision, Inspection and Quarantine (the AQSIQ) regarding the safety supervision in the food processing section, and 3) also the responsibilities and powers previously assumed by the State Administration for Industry and Commerce (the AIC) regarding the safety supervision in the food circulation section. Therefore, the CFDA, now elevated and expanded as a full ministry organization directly reporting to and supervised by the State Council, has become a single safety agency to supervise the whole process of food production, circulation and use, and exercise the drug administration in China. In addition, governments at the province, city or county level, by referring to the SAFD reform in the central government, are consolidating food safety regulatory and supervision functions and creating an elevated food and drug regulatory agency to exercise centralized and uniform regulation and supervision on the food and drugs.

The food quality and safety has caused heated discussions in China for a long time, and concerns are growing among ordinary Chinese in this regard during their daily lives. Targeting at the currently weak food monitoring system, this restructuring of CFDA and its local branches will be considered to create a more effective and powerful regulator on the safety management of food in China. Meanwhile, CFDA will retain all of the legal and administrative powers of SAFD on the drug administration, reflecting the attitude of Chinese government to continue its stringent regulation in this industry.


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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