Many foreign device and drug companies now doing clinical trials, R&D, data collection and other related medical activities in China need to follow China’s HGR regulations. HGR regulations outline what foreign companies need to do when applying for, filing and reporting relevant information per the — “Implementation Rules on the Administrative Regulations on Human Generic Resource Administration.” These updated FAQs are to provide companies with clearer answers related to this regulation.
In many cases, the updated FAQs follow the old FAQs. However, two of the changes among others included in these updated FAQs are listed here. First, with respect to International Collaboration, relevant parties that are not CROs, third-party labs, trial sites, and Sponsors, will now be defined as “other participating parties” if they gain access to HGR information and materials. Second, no longer within the regulatory rules of HGR are biological samples like plasma, serum, etc. However, if data is produced via trials using some of these materials for mathematical research purposes they may still be regulated as HGR — if used for international partnerships, etc. In short, the updated FAQs have tried to reduce the regulatory restrictions on material approvals and the overall supervision of HGR materials.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.ropesgray.com/en/insights/alerts/2023/06/china-unveils-implementing-rules-on-the-administration-of-human-genetic-resources