Implementing Rules for Human Genetic Resources Released by Ministry of Science and Technology
ISSUING AUTHORITY:
The Ministry of Science and Technology
DATE OF ISSUANCE:
June 1, 2023
EFFECTIVE DATE:
July 1, 2023
On June 1, 2023, China’s Ministry of Science and Technology (MOST) officially released the Implementation Rules for the Regulation on Human Genetic Resources Administration (the “Implementation Rules”), which came into effect on July 1, 2023.
The Implementation Rules, which were built upon the earlier draft version issued by MOST on March 21, 2022, address various concerns and issues that have emerged since the implementation of the Administrative Regulations on Human Genetic Resources in 2019.
Firstly, the Implementation Rules specify the scope of human genetic resources (“HGR”) information. In Article 2 of the Implementation Rules, HGR information refers to “human genes, genome data and other information generated by using HGR materials,” and specifically excludes clinical data, imaging data, protein data, and metabolic data.
Secondly, the Implementation Rules have narrowed the scope of collection approval by excluding common diseases such as hypertension, diabetes, color blindness, and hemophilia from the regulation of important genetic lineages. The Implementation Rules also eliminate the collection approval requirements for specific categories of HGR, such as rare diseases, and increase the minimum collection threshold that necessitates approval. Furthermore, the rules provide exemptions for international collaborative clinical trials conducted for obtaining drug or medical device marketing approval.
In addition, the Implementation Rules have introduced streamlined approval procedures for international scientific research collaborations to facilitate smoother cooperation. The newly introduced Article 53 of the Implementation Rules supplements the provisions for non-significant changes. The parties involved in non-significant changes are required to submit relevant materials to MOST for explanation and filing, without the need for approval for the changes.
In general, the Implementation Rules have streamlined the application process for HGR-related activities, taking into account the industry’s concerns and practical needs. However, the Implementation Rules also reflect MOST’s increased focus on strengthening the regulation of HGR.
Reference:
科學(xué)技術(shù)部令第21號(hào)《人類(lèi)遺傳資源管理?xiàng)l例實(shí)施細(xì)則》
