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?
No, a collection license is not required in this scenario.
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?
Only the international scientific research cooperation license / internationally cooperated clinical filing is required.
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?
You should apply for the approval for major change, in accordance with Article 44 and Article 45 of the Implementation Rules on the Administrative Regulations on Human Genetic Resources.
1.5 Should the number of collected HGR samples align with the quantity specified in the research protocol?
Yes. Any deviation from the specified quantity should be accompanied by a clear explanation for the inconsistency.
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?
Upon receiving HGR collection approval, the medical & health institution should submit either the ethical review approval document or the documents demonstrating recognition of the approval documents provided by the HGR collection institution, along with a letter of commitment. After the submission, the medical & health institution can proceed with collecting the HGRs.
2. Administrative License and Filing for International Cooperation
2.1 How should I handle the remaining HGR samples from the international cooperation?
In principle, the remaining samples that retain research value can be returned to the HGR sample provider. Alternatively, they can be temporarily stored for a specified period at a designated location, as indicated in the application, and subsequently disposed of according to relevant regulations.
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?
No, it is not necessary to apply for international cooperation in this scenario.
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?
Yes, it is necessary for the sponsor and the applicant to be consistent. However, if there is a discrepancy between the sponsor and the applicant, the international cooperation application form should include relevant agreements and other documents that outline the rights and responsibilities of the different entities.
2.4 If a partner involved in an ongoing clinical trial project becomes a foreign entity, is it necessary to apply for international cooperation?
Yes. In such a scenario, you should first suspend the project. Next, you need to obtain international scientific research cooperation approval or an internationally cooperated clinical trial filing number. Finally, you may continue with the project.
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?
In the research scenario you described, where a foreign entity has no substantial involvement, access to relevant data, or receives research results from the Chinese side (e.g., foreign-invested pharmaceutical companies solely provide investigational drugs or partial grants to the investigators without any share in research outcomes), the Chinese applicant is not required to obtain a license or filing number for international research.
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?
To proceed with the revised the cooperation, you should promptly suspend the previously filed project and initiate an application for international scientific research cooperation license. The application should include a summary along with all the other necessary supporting documents. After you obtain the license, you can proceed with resuming your research.
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?
Only when the project needs to undergo changes that make it suitable for filing as an internationally cooperated clinical trial, you should proceed with filing the necessary documentation in accordance with the comprehensive circumstances of the project after the modifications have been made.
2.8 In the context of international cooperation involving Chinese entities, what is meant by “other institutions”?
“Other institutions” in international cooperation refers to the institutions that substantially participate in the project and have access to the HGRs within the management scope. This category excludes the sponsor, the leader institution, CROs, third-party laboratories, medical 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?
International cooperation agreements include relevant agreements between the sponsor, the leader institution, CROs, third-party laboratories, and other involved institutions.
When seeking an international scientific research cooperation license, the sponsor, the leader institution, CROs, and third-party labs need to provide related signed and sealed agreements in Chinese demonstrating their interconnections.
When filing for internationally cooperated clinical trials, all the cooperating institutions (the sponsor, the leader institution, CROs, third-party laboratories, and other institutions) need to provide Chinese signed and sealed agreements.
2.11 How should the term “analysis institution” be understood in the context of filing for internationally cooperated clinical trials?
The term “analysis institution” in the filing for international cooperated clinical trials refers to the institutions in the involved in the analysis and processing of genetic information of HGRs or nucleic acid biomarker information.
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?
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?
The information backup and prior reporting should be completed before the data is made openly accessible.
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?
Please refer to the table below for the specific requirements:
Table 1: Information required to be provided in prior report
Purpose of prior report | Mode of provision/use | Information to be provided |
External provision | Network transmission | Transmission URL |
Physical storage media | Recipient’s address |
Open use | Publication in journal, book, or conference | Journal, publishing house, or conference URL |
Information platform | Platform URL |
3.4 Have there been any changes to the requirements for applying for open use of HGR information?
The open use of information is now divided into two types:
1) "Open use": After obtaining a filing number, the applicant can make the data openly accessible for external parties to use. There are no specific post-approval requirements.
2) "Open use after review and approval": The applicant submits an application to the data backup platform and awaits approval from the platform. Once approved, the data can be openly accessed by external parties.
In this case, the open use applicant, data user, backup platform, and other relevant institutions should strengthen data risk management and safety review processes.
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?
As stated in MOST’s service guide, “HGRs include all types of cells, whole blood, tissues/tissue sections, semen, cerebrospinal fluid, thoracic/abdominal effusion, blood/bone marrow smears, hair (with hair follicles), etc. Other human secretions, body fluids, swabs, etc., that do not contain cells are not included and thus not needed to be reported.”
Materials such as urine, feces, serum, plasma, etc., which may contain a very small amount of shed, residual, or free cells or genes are no longer included in 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?
Urine, feces, serum, or plasma are no longer considered within the scope of HGR material management. Therefore, the export of these materials does not need to be licensed or filed.
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?
Serum and plasma are no longer included in the scope of HGR management. However, if serum or plasma is obtained by collecting and processing the whole blood, you should submit an application or file for the whole blood for HGR management.
If the collected whole blood is processed into serum or plasma in a medical & health institution and sent to a testing institution without testing for genes, genomes, transcriptomes, epitomes, nucleic acid biomarkers, etc., the testing institution will be no longer be administered as a third-party laboratory.
If the collected whole blood is sent to a testing institution for processing to obtain serum or plasma, the testing institution will still be administered as a third-party laboratory.
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?
Only when involving international cooperation, external provision or open use of information, the aforementioned materials including urine, feces, serum, and plasma will fall into the scope of application for international scientific research cooperation license / filing for internationally cooperated clinical trial and prior report for external provision or open use of HGR information.
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?
Yes, they should be the same.
4.6 Does the content of the research protocol need to be completely consistent with the cooperation agreement?
The content of the research protocol should not exceed the scope of 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?
If the project has been approved with the license to use Chinese HGRs in international cooperation and later requires a unapproved change, the applicant can proceed with the project only within the previously approved scope. Only after the change is approved can the applicant proceed with the changed project.
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