China’s Ministry of Science and Technology published the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023.
Based on “Human Genetic Resources Management Regulations” effective since July 1, 2019, it simplifies the licensing application and further specifies requirements of international research & clinical trial approval, information provision or open use filing, data backup, supervision, and penalties of human genetic resources.
In 2018, AstraZeneca and five others violated China’s human genetic regulation, resulting in clinical data rejected. Read more.
For English copies of “Details for the Implementation of the Human Genetic Resources Regulations” and “Human Genetic Resources Management Regulations”, please email info@ChinaMedDevice.com.
Circumstances No Longer Need China Human Genetic Resources Approval
The document optimizes the scope of application and reporting for collection, preservation, and international clinical trials. For example,
- It clarifies that the scope of information management is human genes, genomic data, etc. excluding clinical data, imaging data, protein data and metabolic data.
- The resources collection for common diseases such as hypertension, diabetes, red-green color blindness, and hemophilia is not included in the management.
- Clinical trials for drugs and medical devices in China no longer need to declare collection permit.
- Convert international cooperation registration to filling for some matters.
- No longer need to make separate reporting for data and information generated by international scientific research cooperation that have already obtained international license.
In addition, “Human Genetic Resources Management Questions” released in March 2020 clarified the following situations that do not require the filing to human genetic resources office:
- Only collecting ECG data
- For international cooperative clinical trials, provide summary reports or trial data to units which are only Chinese entity
- Utilizing publicly available human genetic resources data
- In the clinical trial, the sponsors, CROs and other cooperating parties are all Chinese entities, and only the EDC suppliers are foreign parties.
In conclusion, the updated rules on Human Genetic Resources Management streamlines more on how and when foreign entities go through the application process. China Med Device wrote a white paper on this topic and helped our overseas clients navigate through the filing/application with China HGRAC. Email info@ChinaMedDevice.com to get the HGRAC white paper.