In March and April 2025, China’s National Health Commission (NHC) published its first formal guidelines on human genetic resources (HGR) after it took over the regulatory oversight of HGR from the Ministry of Science and Technology (MOST) last year. The introduction of a set of frequently-asked questions (FAQs) along with a question and answer (Q&A) document clarifies the parameters of the HGR regulatory framework, including the types of material that are regulated as well as exemptions for some international research collaborations.
The NHC reiterates that some biological materials, such as urine, feces, serum, plasma, and bodily fluids with very little genetic material, are not to be regulated as HGR. The NHC continues to say commercial human cell lines and cell-derived xenograft (CDX) products are also excluded from the definition of HGR. On the other hand, patient-derived xenografts (PDX), whole blood, tissues, and semen will remain as HGR. However, if only plasma or serum is transferred for testing, no HGR approval is needed.
The guidance on international collaboration confirms that HGR approval is not needed when foreign parties only perform electronic data capture services or simply fund a study without access to research data. The NHC’s most recent updates aim to help ease compliance burdens and clarify HGR rules after the transition.
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.