By Pasha Yuen 
Please Click Here for Part 1 and Part 2
Types of HGR licencing
The four types of licence are Collect, Storage, External Share, and International Collaboration Administrative Licence (hereafter administrative licence). These refer to different levels of constraints for the use of genetic resources. The applicant with the administrative licence has the highest level of rights, which includes the collection, storage, and sharing of HGR resources and data. To conduct a large-scale population study in China, the sponsor is required to apply for the administrative licence.
A simplified licence – the pre-approval memo – can be applied for, if the following conditions are fulfilled:
- To conduct a clinical trial for obtaining marketing authorisation of the investigational product in China
- If HGR samples are being collected in designated local clinical institutions, approved by the market authorities
- Collected HGR sample data is not being exported and analysed outside China
How to Apply for an Administrative Licence?
In most cases, the sponsor is required to apply for the administrative licence. The application process involves documentation submission to the relevant governing body in China. It is important to contact the organisations in China well in advance of the clinical trial initiation to make sure everything is in place.
Before submitting all relevant documents, the sponsor must register an account as a legal entity on the official HGR service system website (Here is our handy link to it). The applicant is also required to register a “natural person” on the platform (in addition to a “Legal entity”). The registered account will then be used for completing the online application form.
All relevant documents should be submitted along with the application form as an appendix, which includes legal entity identity documents, clinical trials approval, informed consent form template, letter of ethical approval, international collaboration agreement (in Chinese), letter of commitment from all contracted organisations, registration materials, and clinical trial approval document from the drug regulatory department.
Below is the flowchart for the application process.
The application would be reviewed and approved within 20 working days. In rare situations, the review process may be extended for up to 10 working days, but the applicant would be notified in advance. The applicant will receive a confirmation email within 10 working days once the application is approved, and the application outcome would be also published on the National Health Commission (NHC) official website (Follow this link).
What happens next?
If the licence expires during the study, it is the sponsor’s responsibility to apply for renewal as soon as possible, up to 30 working days before the expiry date.
Towards the end of the study, an investigational report should be jointly submitted by the sponsor and the local collaboration organisations to the NHC. The report should be completed within 6 months of the licence expiration. The following is the key information to be included in the report:
- Protocol Amendment (e.g., changes on the aim or content of the study)
- Research Plan Execution
- Investigational Plan and Completion Status
- Informed Consent Form Template
- HGR Sample Utilisation and Disposal
- Documentation of Data Collection, Storage, and Usage during the study
- All records of Local (Chinese) Unit researchers and/or foreign researchers
- Output, Attribution, and Distribution of Rights and Interests or research outcome
- Ethical Review
How to save time
Completing this application in a foreign language could be complicated, and therefore the sponsor is recommended to collaborate with a local CRO in China to support the application process. It is also important to have a thorough understanding of the guidelines, to ensure all relevant documentation has been prepared to enable full compliance with the HGR regulations. Missing or incorrect documentation will cause delays in the application. The CRO should be familiar with these types of applications and will spend some time gathering the right documentation so that it can all be submitted correctly. Selecting the CRO, providing them with the right documents and making updates to clinical trial documentation where required is the most time-consuming part, therefore start this process early to make sure your approval is in time for the start of your study.
For more information, please visit the NHC website for detailed guidance and frequently asked questions.
https://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/bmgz/202306/t20230601_186416.html
https://fuwu.most.gov.cn/r/cms/zwpt/web/assets/pdf/7.rlyczygjhzlcsybafwhcx.pdf
https://zwfw.nhc.gov.cn/bsp/rlyczyfwxt/202405/t20240517_2758.html
https://www.gov.cn/zhengce/zhengceku/202307/content_6892108.htm
