FAQs on China's Human Genetic Resources (HGRs)

by Grace Wang
Oct 24, 2023

On Sept. 12, 2023, China’s Ministry of Science and Technology (MOST) released a series of frequently asked questions (FAQs) regarding the administration of human genetic resources (HGRs). These inquiries were received by MOST after the Implementation Rules on the Administrative Regulations on HGRs took effect in July this year, as the ministry is responsible for approving HGR usage applications.

BaiPharm has provided a translated version of the FAQs for the convenience of foreign stakeholders. However, in the event of any inconsistency between the translation and the original Chinese version, it is essential to adhere to the official notice issued by MOST.

1. Administrative licenses for HGR collection and preservation

1.1  For a long-term large-scale cohort study, do I need to apply for both a collection license and a preservation license?

No. For a project with a specific research aim, you can only apply for a collection license. But if the samples need to be stored for a long time, you should store them at a depository with a HGR preservation license.

1.2  Do I still need to apply for a collection license when use HGRs that have been approved for preservation?
1.3  Which application/filing is required for a project that is qualified for a collection license and within the scope for international scientific research cooperation license/ internationally cooperated clinical trial filing?

1.4  What application should I submit if there’s a change to the name of the approved items on the HGR collection/preservation license?
1.5  Should the number of collected HGR samples align with the quantity specified in the research protocol?
1.6 Once the HGR collection approval is obtained, should the medical & health institution involved in utilizing the HGRs submit the ethical review approval document and the letter of commitment to the MOST?

2. Administrative License and Filing for International Cooperation

2.1 How should I handle the remaining HGR samples from the international cooperation?
2.2 If the sponsor, contract research organization (CRO), and other cooperating parties involved in a clinical trial are all Chinese entities, with the exception of the electronic data capture (EDC) provider being a foreign entity, is it necessary to apply for international cooperation?
2.3 Is it required for the sponsor of a clinical trial seeking marketing authorization to match the applicant for the approval document, notification letter, or filing documents intended for publication?
2.4 If a partner involved in an ongoing clinical trial project becomes a foreign entity, is it necessary to apply for international cooperation?
2.5 If a foreign entity provides funding but does not substantially participate in the scientific research using China’s HGRs, is it necessary for the Chinese applicant to apply for international scientific research license or file for internationally cooperated clinical trial?

2.6 The project was initially filed as an internationally cooperated clinical trial project. However, due to some changes, the project now requires transformation into an international scientific research cooperation. What steps should I take to apply for the appropriate license for this revised cooperation?
2.7 What should I do if a previously approved international scientific research cooperation project becomes eligible for filing as an internationally cooperated clinical trial project?
2.8 In the context of international cooperation involving Chinese entities, what is meant by “other institutions”?
2.9 When applying for an administrative license for international scientific research cooperation, and the CRO and the third-party laboratory involved are foreign entities, is it required for the CRO an lab to provide ethical review documents from their country of origin?
2.10 What international cooperation agreements need to be submitted for seeking administrative license for international scientific research cooperation and filing for internationally cooperated clinical trial?
2.11 How should the term “analysis institution” be understood in the context of filing for internationally cooperated clinical trials?
2.12 In the filing for internationally cooperated clinical trials, if the testing, analysis, and remaining sample process are conducted by the domestic institutions in China, can the relevant information of these institutions be submitted as an attachment to the clinical trial protocol?

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3. Prior Report Before the Provision or Open Use of Information to External Parties

3.1 To publish an article that involves the open use of HGRs information, when should the information backup and prior reporting be conducted?
3.2 Is it necessary to create backup information and submit a prior report when using published HGR data?
3.3 What are the requirements for completing in the storage location/website/code of the information reported in advance?
3.4 Have there been any changes to the requirements for applying for open use of HGR information?
3.5 When transmitting the HGR information generated in a project to EDC suppliers, statistics companies, or other external parties for data management as specified in the agreement, is it necessary to create backup information and submit a prior report?

4. Other FAQs

4.1 Are urine, feces, serum, plasma, and other materials within the scope of HGR management?
4.2 If the material export application only involves materials such as urine, feces, serum, or plasma, is it necessary to apply for a license or filing for them?
4.3 How should I fill in the application/filing information when I collect whole blood samples for scientific research but the actually test the serum or plasma?
4.4 Does HGR information generated by using urine, feces, serum, plasma, or other materials to detect genes, genomes, transcriptomes, epigenomes, and nucleic acid biomarkers in scientific research need to be declared?
4.5 Does the name of project with ethical review and approval need to be exactly the same as the name of the HGR application/filing project?
4.6 Does the content of the research protocol need to be completely consistent with the cooperation agreement?
4.7 In the process of applying for changes to an approved project, can I proceed with the research and select subjects to enter the clinical trial?


Grace Wang
ChemLinked Regulatory Analyst & Editor
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