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Highlights of the CFDA Restructuring Plan

Jul
1
2013

After the re-organization, the CFDA expanded its internal departments from 10 offices to 17, including the General Office, the Department of Policy, the Department of Legal Affairs, the Departments of Food Safety Supervision (I, II and III), the Department of Registration of Drugs and Cosmetics, the Department of Registration of Medical Devices, the Department of Drug and Cosmetics Supervision, the Department of Medical Device Supervision, the Bureau of Investigation and Enforcement, the Department of Urgency Management, the Department of Technology and Standards, the Department of Communications, the Department of Human Resources, the Department of Planning and Finance, and the Department of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs). Notably, the Department of Food Safety Supervision increased from 1 to 3, in order to exercise oversight over the entire supply chain and strengthen the vigilance system.

 

The CFDA retrieved legislative authority concerning food and drug laws, as well as qualifying authority for the food safety testing institutions from the Ministry of Health. The agency also retrieved the certification authority for medical devices as well as the manufacturing approval authority and compulsory inspection authority concerning cosmetics from the General Administration of Quality Supervision, Inspection and Quarantine (the “AQSIQ”).

Some of the CFDA’s approval authorities are delegated to the provincial Food and Drug Administrations (the “Provincial FDAs”), including:

  • GMP certifications for drugs and medical devices,
  • Renewal of drug registrations and supplementary applications relating to drug registration (excluding those changes affecting product quality),
  • Application for change of registration (excluding those changes affecting product quality) for locally-produced Class III medical devices,
  • Drug contract manufacturing, and
  • Approvals related to imported non-special-use cosmetic products.

Source: www.lexology.com                                                                                                Publication Date: 2013-05-21