China's Ministry of Science and Technology released the "Details for the Implementation of the Human Genetic Resources Regulations", effective on July 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.
Circumstances No Longer Need China Human Genetic Resources Approval
The document optimizes the scope of application and reporting for collection, preservation, and the filing of international collaborative 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 key genetic family management.
- Clinical trials for drugs and medical devices in China no longer need to apply for collection approval.
- Convert international cooperation registration to filling under certain conditions.
- No longer need to report in advance or submit information backup for data and information generated by international scientific research collaboration, that has already obtained administrative permission or have completed filing.
In addition, "Human Genetic Resources Management Questions" released in March 2022 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 Chinese entity only
- Utilizing publicly available human genetic resources data
- In the clinical trial, the sponsors, CROs and other collaborative parties are all Chinese entities, and only the EDC suppliers are foreign parties.
In conclusion, the updated "Rules on Human Genetic Resources Management" specifies more on how and when foreign entities are required to go through the application process. If you have questions in how to navigate through the filing/application with China HGR Regulations. Please email me.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------