Caixin explains: How China is reviewing its genetic resources regulations

China’s biotechnology sector is undergoing significant regulatory changes due to increasing global competition and the need for greater involvement in the development of new treatments. (pt. 1) China has the richest human genetic resources in East Asia thanks to its large, ethnically diverse population.(pt. 2) According to Jin Li of Fudan University, the genetic diversity of China’s 56 ethnic groups makes them an invaluable source of scientific research and public health. (pt. 3) Human genetic resources include organs, tissues, cells and genetic materials such as blood, saliva and cerebrospinal fluid, which are crucial for the development of new medicines and are critical to national biosecurity. (pt. 4)(pt. 5)

China’s biotechnology industry is constrained by stringent regulations introduced in 2015. These regulations include strict oversight of the collection, conservation, transportation and use of human biological materials, resulting in lengthy approval processes that hamper innovation. (pt. 6)(pt. 7) To address this issue, in early 2023, China began transferring regulatory control over genetic resources from the Ministry of Science and Technology (MOST) to the National Health Commission (NHC) to focus on public health. (pt. 8) The NHC is reviewing these rules to streamline procedures, increase regulatory efficiency, and revitalize biopharmaceutical research. (pt. 9)(pt. 10)

China’s regulatory overhaul began in March 2023 with a national legislative restructuring plan. In July, MOST closed its Genetic Resources Office, and in March 2024, NHC took over its supervision. (pt. 12) The NHC held several discussions with industry experts to balance necessary regulation with relaxed controls to spur innovation. (pt. 13) The main proposed changes include raising the administrative threshold for genetic resources projects and clarifying the definition of foreign entities to reduce unnecessary regulatory overlap and facilitate application processes. (pt. 14)

Strict regulations over the past decade have led to delays in drug research and increased the difficulty of international cooperation. Studies have shown that the time required for clinical trial approval in China can be six months longer than in the U.S., significantly slowing the development of new drugs. (pt. 17) Tightening regulations since 2019 have also slowed genetic testing, prompting the industry to call for more effective regulation. (pt. 18)(pt. 19)

Foreign collaborations are negatively impacted by strict compliance requirements for the export of genetic data and the formation of partnerships. Companies classified as foreign entities incur significant administrative costs that deter foreign investment and force entrepreneurs to adopt risky structural strategies such as variable interest entity (VIE) arrangements. (pt. 24) These issues have highlighted the need for regulatory changes to facilitate international collaboration in biomedical research while protecting biosecurity. (pt. 25)

The proposed rule changes are intended to raise the threshold for projects requiring approval and narrow the definition of foreign entities, potentially making Hong Kong and Macau more attractive to foreign investors. (pt. 27)(pt. 28) Experts believe that these changes will make regulations more precise and effective, which will bring significant benefits to the biotechnology and research sectors. (pt. 29) China’s regulatory framework for human genetic resources, established piecemeal since 1998, has evolved into a more comprehensive and stringent system by 2019, with the latest guidelines taking into account industry feedback to relax requirements. (pt. 31)(pt. 32)(pt. 34)

On a global scale, the management of human genetic resources is a challenge influenced by geopolitical and economic factors. National security concerns often drive tighter regulations, but experts recommend carefully addressing biosecurity and gene weapons issues to avoid over-regulation and public confusion. (pt. 36)

These changes reflect China’s ambition to balance stringent regulation with supporting a competitive environment in the biotechnology sector to keep pace with global progress.

Artificial intelligence generated, for informational purposes only