The Ministry of Science and Technology Announced Questions & Answers on the Human Genetic Resources Administration
ISSUING AUTHORITY:
The Ministry of Science and Technology
DATE OF ISSUANCE:
September 12, 2023
EFFECTIVE DATE:
September 12, 2023
On September 12, 2023, the Ministry of Science and Technology published the Questions & Answers on the Human Genetic Resources Administration (“Q&A”), which came into effect on September 12, 2023. The Q&A reflects the latest regulatory requirements of human genetic resources management in China after the issuance of the Implementing Rules for the Administrative Regulation on Human Genetic Resource and that the previous versions of the Q&A are invalid.
Firstly, the Q&A further relaxes the scope of regulation of human genetic resource materials by stipulating that biological samples such as urine, feces, serum, plasma, etc. are no longer included in the scope of management of human genetic material, even though such materials may contain very small amounts of shed, residual or free cells or genes.
Secondly, the Q&A emphasizes that for the projects that fall within the scope of both the collection administrative license and international scientific research cooperation license, only the latter needs to be submitted. In addition, if the applicant is involved in both the collection administrative license and the international cooperative clinical trials filing, the collection administrative license does not need to be submitted either. The abovementioned clarification is already an important advantage for international cooperation projects, as it avoids the trouble of repeated applications and multiple approvals.
On top of that, the regulation of the use of human genetic resources by foreign entities has been appropriately relaxed accordingly. For example, foreign entities using publicly available information on human genetic resources are not required to submit information backup and prior reports. In addition, the transfer of research-generated information on human genetic resources to foreign entities, such as EDC providers or data statistics companies, to carry out work in accordance with the agreed scope of data management also does not require an information backup and prior reporting procedures either.
In general, the regulation of human genetic resources in China is constantly improving, while at the same time gradually relaxing in some areas. China’s regulation of human genetic resources is now more flexible, which is conducive to the development of the medical and healthcare industry.
