China Releases Detailed Implementation Rules For Managing Human Genetic Resources

On June 1, 2023, the Ministry of Science and Technology of China has announced the issuance of the Detailed Implementation Rules for the Regulations on the Management of Human Genetic Resources. These rules were approved on May 11, 2023 and will be effective from July 1, 2023.

The aim of these rules is to safeguard public health, national security, and social public interests while ensuring the effective protection and reasonable utilization of China’s human genetic resources. They have been developed in accordance with relevant laws and administrative regulations, including the Biosecurity Law of the People’s Republic of China and the Regulations on the Management of Human Genetic Resources of the People’s Republic of China.

The rules stipulate that the collection, preservation, utilization, and provision of human genetic resources in China must comply with the detailed implementation guidelines. Human genetic resource information, such as human genes and genomic data generated from the utilization of these resources, falls within the scope of these rules. However, clinical data, imaging data, protein data, and metabolic data are not considered human genetic resource information.

To ensure effective oversight, the Ministry and provincial-level science and technology administrative departments will strengthen their supervision capabilities by appointing administrative law enforcement personnel. In addition, the Ministry of Science and Technology will establish a Human Genetic Resources Management Expert Consultation Committee. Comprising experts in various relevant fields such as life sciences, medicine, health, ethics, law, and information security, the committee will provide decision-making consultation and technical support for the national management of human genetic resources.

Furthermore, the detailed implementation rules also provide a comprehensive description of chapters on investigation and registration, administrative licensing and filing, supervision and inspection, and administrative penalties.

With the release of these detailed implementation rules, China takes a significant step in regulating and managing its human genetic resources in a manner that balances protection, utilization, and oversight.

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