New version of "Detailed Implementation Rules for the Regulations on the Management of Human Genetic Resources" released

The National Health Commission today (11th) released the newly revised "Details for the Implementation of the Regulations on the Management of Human Genetic Resources".

In order to thoroughly implement the reform spirit of the party and state institutions, in accordance with the latest revisions involving the adjustment of human genetic resources management responsibilities in the "Biosafety Law of the People's Republic of China" and the "Regulations of the People's Republic of China on the Management of Human Genetic Resources", the National Health Commission organized and revised the "Details for the Implementation of the Regulations on the Management of Human Genetic Resources" issued by the former Ministry of Science and Technology in June 2023 (hereinafter referred to as the "Details").

This revision adheres to the overall coordination of development and safety, and aims at "safe management, respecting rights and interests, promoting sharing, and efficient utilization" to effectively protect and rationally utilize my country's human genetic resources, safeguard national biosecurity and social public interests, and promote high-quality development in the field of medicine and health. Revise the higher-level laws and regulations, implement legal responsibilities and reform requirements, mainly adjust the regulatory entities, optimize the approval and filing management system, improve the supervision chain, etc., to ensure the standardized, safe and efficient use of my country's human genetic resources.

The "Detailed Rules" contain eight chapters and sixty-one articles. Chapter 1 General Provisions stipulates the scope of application, relevant definitions, responsibilities of all parties, etc. Chapter 2 Investigation and Registration clarifies the responsibilities of national and provincial authorities, conducts investigations and registration of important genetic pedigrees, and establishes a dynamic list. Chapter 3 Collection of Human Genetic Resources clarifies the collection application conditions, multi-center collection procedures, etc. Chapter 4, Preservation of Human Genetic Resources, clarifies the preservation application conditions, application unit management requirements, etc. Chapter 5 uses human genetic resources to carry out international cooperation, clarifying the application conditions, application rules, cooperative research status reports, changes in matters, etc. for international cooperative scientific research. Chapter 6: The export of human genetic resource materials and the provision or open use of information to the outside world, stipulates declaration rules, simplified procedures, etc. Chapter 7, Service and Supervision, clarifies the regulatory responsibilities, supervision and inspections, emergency and rapid approval systems of competent departments at all levels.

(CCTV reporters Wen Yongyi and Shi Yingchun)