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
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.
No, a collection license is not required in this scenario.
Only the international scientific research cooperation license / internationally cooperated clinical filing is required.
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.
Yes. Any deviation from the specified quantity should be accompanied by a clear explanation for the inconsistency.
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
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.
No, it is not necessary to apply for international cooperation in this scenario.
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.
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.
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.
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.
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.
“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.
No, it is not required.
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.
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.
Yes, it is permissible.
3. Prior Report Before the Provision or Open Use of Information to External Parties
The information backup and prior reporting should be completed before the data is made openly accessible.
No, it is not required.
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
Physical storage media
Publication in journal, book, or conference
Journal, publishing house, or conference URL
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.
4. Other FAQs
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.
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.
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.
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.
Yes, they should be the same.
The content of the research protocol should not exceed the scope of the cooperation agreement.
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.