Key Takeaways of the New HGR Guidelines 

July, 2023 - Yang (Aaron) Gu, Pengfei YOU, Duzhiyun ZHENG, Fengqi YU

On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for international collaboration filing and data sharing reporting of HGRs (collectively "New Administrative Guidelines"). The New Administrative Guidelines have been officially implemented on July 1, 2023 and serve as the supporting documents for the Regulations on the Administration of Human Genetic Resources ("HGR Regulations") and the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which have attracted due attention from the industry since its release by the MOST on June 1, 2023 (for reference, please refer to Highlights on HGR Regulation Implementation Rules and its Chinese version 汉坤 • 观点 重磅首发:《人类遗传资源管理条例实施细则》要点解读). The New Administrative Guidelines have further clarified and refined the regulatory requirements of HGR Regulations and Implementation Rules and have provided convenience and guidance for related parties to fulfill compliance obligations and go through the administrative approval, filing and reporting procedures.


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