In late March and early April 2025, China’s National Health Commission (“NHC”) released a notice addressing frequently asked questions (“FAQ”) related to human genetic resources (“HGR”) management, along with additional shorter Q&A documents (see here and here), which answer one main question each.  These publications mark the first set of guidelines issued by the NHC since it assumed regulatory oversight of the HGR Regulation on May 1, 2024, replacing the Ministry of Science and Technology (“MOST”). 

The HGR regulatory regime has changed significantly in recent years, including with the introduction of the Human Genetic Resource Regulation Implementing Rules (“HGR Implementing Rules”) in 2023 and the transfer of authority for administration of the regime from MOST to NHC last year.  Consistent with the previous notices from MOST, which simplified the application process of certain HGR approvals, the NHC appears to continue its predecessor’s efforts to simplify regulatory procedures and ease certain stringent requirements under the HGR Regulation.  While these documents largely retain content introduced by MOST in 2023, they help clarify which rules remain applicable following the transition of authority, and clarify the meaning of those rules in some cases.  Below are key takeaways from the new guidelines and their implications.

Narrowed Scope of HGR

HGR consists of HGR materials and HGR information.  Under the HGR Regulation, HGR materials encompass organs, tissues, cells, and other genetic substances containing human genomes or genes, while HGR information refers to data derived from the use of such materials. In 2022-2023 MOST significantly narrowed the scope of covered information and ultimately human samples.

Like the MOST Q&A following the adoption of the HGR Implementing Rules, the NHC’s FAQ explicitly excludes certain biological samples—bodily fluids, swabs, and specimens such as urine, feces, serum, and plasma—if they contain only minimal residual genetic material.  These exclusions mean that the collection, use, and export of such materials will no longer require approval from the NHC.  Additionally, the April Q&As explicitly exempt the following two items from HGR regulation: (1) commercial human cell lines, which applies to immortalized cell lines used in production or scientific research that lack traceable sample information; and (2) cell-derived Xenograft (CDX), although it clarifies that patient-derived tumor Xenograft (PDX) will still be regulated as HGR materials.

The FAQ also clarifies that HGR materials still include whole blood, all cell types, tissues/tissue sections, semen, cerebrospinal fluid, pleural/abdominal fluid, blood/bone marrow smears, and hair (with follicles).  Importantly, the FAQ makes it clear that if whole blood is collected from the patients but only plasma or serum is transferred from the hospital collection site to the laboratory for testing, then the HGR regime does not apply to that circumstance.

Exceptions of International Collaboration Approvals/Filings

Under the HGR Regulations, foreign entities, including those indirectly controlled by foreign individuals or entities, must collaborate with domestic entities—such as universities, research centers, hospitals, or enterprises— in “international collaborations” when utilizing Chinese HGR for scientific research. Those collaborations are either approved or record-filed (i.e., notified) by the regulator, depending on the circumstances.

The FAQ maintains and clarifies important specific exemptions:

  • If the only foreign entity involved in a study is one that is providing electronic data capture (EDC) services, an HGR approval/notification is not needed.
  • If a foreign entity funds a clinical study—such as by supplying investigational drugs or financial subsidies—without sharing research results, collaboration approval and record-filing requirements are likewise inapplicable.

Conclusion The NHC’s latest guidance continues efforts to streamline regulatory procedures while clarifying post-transition rules.  Stakeholders should continue to monitor further implementation measures from the NHC as the regulatory landscape evolves.

For further information or inquiries relating to this post, please email APACRegBlog@cov.com.

Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.

Photo of Kexin Yang Kexin Yang

Kexin Yang focuses on government and internal investigations, as well as regulatory work related to food, drugs, and medical devices in China. She has experience advising multinational companies on highly sensitive investigations in China and other countries in Asia, particularly in the areas…

Kexin Yang focuses on government and internal investigations, as well as regulatory work related to food, drugs, and medical devices in China. She has experience advising multinational companies on highly sensitive investigations in China and other countries in Asia, particularly in the areas of FCPA and export controls. In the regulatory sphere, Kexin advises companies in the food, pharmaceutical, biotechnology, medical device, and cosmetics sectors, as well as trade associations, on compliance with Chinese regulations. She has also supported life sciences transactions by evaluating regulatory and compliance risks and advising on commercial agreements.

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Photo of John Balzano John Balzano

John has over twenty years of experience with legal and regulatory issues related to China and the Asia Pacific Region (APAC), particularly with regard to products regulated in Mainland China by the State Administration for Market Regulation, the National Medical Products Administration (NMPA)…

John has over twenty years of experience with legal and regulatory issues related to China and the Asia Pacific Region (APAC), particularly with regard to products regulated in Mainland China by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China and APAC, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, implementing product recalls, and supporting virtual and onsite overseas quality inspections. John also has significant experience designing strategies to handle professional consumer litigation for companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

He is the author of the book, China Food and Drug Law: Policy, Practice, and Future Directions (Springer 2024).

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Photo of Julia Post Julia Post

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development…

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development matters, including informed consent requirements, biospecimen procurement and research use, and other good clinical practice. She advises clients regularly on product life-cycle management issues, including patent linkage frameworks and marketing exclusivity in the U.S. and China.

Julia works with pharmaceutical, medical device, food, and cosmetics clients on complex regulatory compliance matters and helps them develop their advocacy strategies before U.S. and China regulators, at both national and local levels. She regularly assists companies and trade associations on policy issues, including the development and submission of comments on legislative and regulatory proposals. Julia works closely with local counsel throughout the Asia-Pacific region to assist clients with their marketing approval and compliance strategies.

Prior to joining the Food, Drug, and Device practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

Julia has an active pro bono practice at Covington, with a particular focus on reproductive justice matters and representation of third-party caregivers and children in custody cases.

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