BEIJING, Nov. 11 (Xinhua) -- China has issued a set of revised rules on the collection, preservation and use of human genetic resources, tightening safeguards for personal information and national biosecurity, while streamlining regulatory procedures for research and medical applications.
The National Health Commission (NHC) published an updated version of the detailed implementation rules for the management of relevant resources on its website on Wednesday, revising a document first issued in 2023.
The rules cover activities involving the collection, preservation and use of China's human genetic resources within the country, as well as providing such resources and information overseas.
Human genetic resources generally refer to human organs, tissues and cells containing genetic materials such as DNA, as well as the genetic information derived from them.
The NHC said the revisions optimize relevant approval and filing procedures and strengthen the regulatory and supervision framework, aiming to ensure that human genetic resources are used in a standardized, secure, and efficient manner, while supporting high-quality development in the pharmaceutical and healthcare sectors.
Under the rules, activities involving human genetic resources must comply with relevant laws, regulations and other requirements. They must not endanger China's public health, national security or the public interest.
Also, they must adhere to ethical principles and abide by relevant scientific and technological standards, protocols and specifications, the document said.
The rules also require the privacy and personal information rights of individuals providing human genetic resources be respected and protected during the relevant process. Relevant operations must be based on prior informed consent, and the legitimate rights and interests of providers must be safeguarded.
Overseas individuals and organizations are prohibited from collecting or preserving China's human genetic resources within the country or providing such resources to overseas entities, according to the rules.
Foreign organizations seeking to use China's human genetic resources for scientific research must comply with Chinese laws and regulations, and conduct their research in cooperation with Chinese institutions.
Any entity conducting international collaborative research using China's human genetic resources must obtain approval from the NHC, the document said, adding that the export of human genetic resource materials -- including their shipment, mailing or transportation out of China -- also requires NHC approval, as well as completion of customs procedures.
The document also stipulates rules for the procedures of relevant applications, approvals and the authorities' supervision responsibilities. ■
