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China’s State Council Publishes New Regulations on the Management of Human Genetic Resources

China’s State Council, the country’s top administrative authority, released a new Regulation of Human Genetic Resources (the "Regulation") on May 28, 2019, to replace the tentative rules issued in 1998. The Regulation, which will take effect on July 1, 2019, illustrates the Chinese government’s clear intent to position the regulation of HGRs as one of its national security priorities. Specifically, the Regulation closely scrutinizes all HGR-related activity from upstream collection of human biospecimens to downstream exploitation and sharing of the material and any data obtained from it. It formalizes the approval requirements pertinent to research collaborations between Chinese and foreign-owned (including both partially and wholly foreign-owned) entities to avoid uncertainty during the approval process. It also significantly increases and expands penalties for various violations of the Regulation.

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China FDA Announces Key Appointments and Restructuring Plan


Time to Read: 2 minutes Practices: China Life Sciences

Following its recent re-elevation to the ministry level and the appointment of a new Commissioner in March, Mr. Yong Zhang, former Director of the Food Safety Office under the State Council of China, the China Food and Drug Administration (the “CFDA”) published a restructuring plan on May 15, 2013 to clarify its responsibilities and internal structures.

Highlights of the CFDA restructuring plan include the following:

1. Appointment of Deputy Commissioners

The former Commissioner of SFDA, one former Deputy Commissioner of the State Administration of Industry and Commerce, and two Deputy Directors of the Food Safety Office were appointed as Deputy Commissioners of the CFDA. Two of the four former Deputy Commissioners of SFDA were appointed as the Director General for Food and Drug Safety.

2. Expansion of internal departments

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.

3. Consolidation and delegation of authorities

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.
If you would like to discuss the foregoing or any other related matter, please contact Katherine Wang or your usual Ropes & Gray advisor.

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