China Human Genetic Resources rules (2019, 2023)

China, administrative regulation. The Regulation on the Administration of Human Genetic Resources was adopted by the State Council on 20 March 2019 (Decree No. 717) and took effect on 1 July 2019, replacing interim measures from 1998; the Biosecurity Law (effective 15 April 2021) gave it a statutory footing, and the Ministry of Science and Technology's Implementing Rules took effect on 1 July 2023. Primary text: the Chinese texts are published by the State Council and the Ministry of Science and Technology; no official English consolidation is maintained, so this record gives no primary link.

What it requires: human genetic resources means organs, tissues, cells and other materials containing the human genome, and the data generated from them. Foreign organisations, and Chinese entities they control, may not collect or preserve them in China and may use them only through collaboration with a Chinese partner. International collaborations need approval from the Human Genetic Resources Administration of China, except that clinical trials at Chinese sites for the purpose of marketing authorisation in China may proceed by filing, a simplification of 2019 extended in 2023; export of materials needs approval, and providing genetic data abroad needs filing or, where national security may be affected, a security review. The 2023 rules clarified that 'foreign' includes entities with foreign shareholders holding controlling stakes and narrowed the scope of data covered.

Why it matters for oncology and the arguments: multinational sponsors running trials in China must plan for approvals before biomarker samples or sequencing data can leave the country, and central laboratories abroad are often replaced by Chinese ones. Sponsors describe months of delay and uncertainty about which data count; China frames the rules as sovereignty over a resource that foreign companies once exported freely, citing episodes from the 1990s. The rules are one of the reasons the BIOSECURE Act debate in the United States and China's own data laws now shape where cancer genomics work is done.