What China Regulations on Management of Human Genetic Resources State Council Order No. 717 2019 Collection Preservation International Use and Cross-Border Sharing Approval Regime requires
The People's Republic of China Regulations on the Management of Human Genetic Resources promulgated by State Council Order No. 717 effective 1 July 2019 administered by the Ministry of Science and Technology Human Genetic Resources Administration of China establish a comprehensive approval and oversight regime for the collection preservation utilisation and international cooperation involving Chinese human genetic resources organised across operative chapters including Chapter 1 General Provisions establishing scope and definitions of human genetic resources covering organs tissues cells and derived DNA proteins and genetic information Chapter 2 Collection requiring approval from the Ministry of Science and Technology for collection of important genetic family resources and resources from specific regions Chapter 3 Preservation establishing requirements for preservation institutions including ethical review and data security Chapter 4 Utilisation requiring scientific research justification ethical review and reporting of intermediate results Chapter 5 International Cooperation prohibiting cross-border transfer of materials without approval and requiring data sharing review for cross-border data flows Chapter 6 Supervision and Administration establishing inspection and reporting authority and Chapter 7 Legal Liability including fines up to 10 times illegal gains or RMB 1 million for individuals and RMB 10 million for entities plus confiscation of resources and revocation of licenses. The 2023 implementing rules further detail the approval pathways.
Pillar: Biotech & Genomics · Authority: Ministry of Science and Technology of the People's Republic of China and Human Genetic Resources Administration of China · Version: 1.0.0 · Last updated:
Primary source: https://english.www.gov.cn/policies/latest_releases/2019/06/10/content_281476708945462.htm
SHA-256 integrity: fa246d570aa39d1fea51b9720a2487f0956a87baf79bb0063d54789f9f13911b
Primary Citations — 8 traced to source
- Regulations on the Management of Human Genetic Resources State Council Order No. 717 2019 https://english.www.gov.cn/policies/latest_releases/2019/06/10/content_281476708945462.htm
- Ministry of Science and Technology of the People's Republic of China portal http://www.most.gov.cn/
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