8th November, 2017
Ministry of Science and Technology of the People´s Republic of China published the new administration process of human genetic resources in clinical trial in the end of October.
It is applicable to clinical trials, which are developed in multi-sites internationally, and involves the Chinese human genetic resources in order to obtain the listing of drugs and medical equipment in China.
The content includes the application method, the audit condition, the process of project change, the online submission platform, the responsibility assignment, and the audit process. The application form is also attached in the annex.
The audit conditions below must be clearly listed in the clinical trial plan before submitting the application.
1. The purpose of obtaining and collecting human genetic resources is clear and lawful;
2. The plan of acquisition and collection is reasonable;
3. Establish the departments and management systems with responsibility for human genetic resource;
4. Having the sites, facilities, equipment and personnel which are suitable for obtaining and collecting activities;
5. Acceptance by the Ethics Committee;
6. The involved parties have the ability to carry out the relevant work;
7. The template and guidance of informed consent of the human genetic resources provider;
8. The source of human genetic resources is clear and legal. The information of the species and quantity shall be the same as the research content;
9. Reasonable cooperation period;
10. The draft of the cooperation agreement;
11. The ownership of intellectual property is clear and the sharing policy is reasonable;
12. There is no harm to Chinese public health, national security and social public interest;
13. Other conditions provided for in accordance with the laws and regulations.
The Notification of Optimizing the Administration Process for Human Genetic Resources