On March 21, 2022, China’s Ministry of Science and Technology (MOST) released the draft version of the Implementing Rules for Human Genetic Resources Management to seek public opinion by late April. The release of this document signals the Chinese authorities’ intention to help facilitate clinical trials conducted by biotech companies that use human genetic resources (HGR) in their studies.
According to the draft regulations, manufacturers only need to apply for HGR approval from MOST if they collect critical genetic resources from certain geographies or conduct studies that entail a sample size larger than 3,000. Manufacturers can proceed with the collection of HRG for their clinical trials without first obtaining approval from MOST if their trials are conducted to support a pharmaceutical or medical device registration and do not involve the transfer of HGR to a foreign country. They can initiate the clinical trials after the submission of the commitment letter and ethical approval to MOST.
In addition, the scope of what is considered HGR data has been narrowed down to data generated from materials containing human genome or genes. Other types of data will not be regulated as HGR data.
Although the draft rules make it easier for biotech companies to initiate clinical trials in China, they also establish penalties for violations of HGR regulations. Foreign manufacturers charged with violation of the rules may face up to 10 million RMB (about 1.5 million USD) in penalties.