China Human Genetic Resources Management Office Streamlines Approval Process for Some Projects

On January 07, 2020, the Ministry of Science and Technology of the People's Republic of China issued a notice on simplifying the approval process for some administrative approval projects.

The notice pointed out: In order to deepen the reform and shorten the administrative approval time, it was decided to implement a simplified approval process for some administrative approval projects.

I. Scope of application

During the process of conducting scientific research on international cooperation using human genetic resources, if the partner, research purpose, research content, cooperation period and other major matters change, a change permit approval shall be conducted. Where the change does not involve changes in the type, quantity, or use of human genetic resources, it can be carried out in accordance with a simplified process, mainly including the following:

1. Changes in scientific research activities for international cooperation in human genetic resources.

1) Changes in participating units;

2) Changes of units other than the parties to the cooperation;

3) Extend the duration of the event;

4) Changes in research protocols, but not involving changes in the type, quantity, or use of human genetic resources, such as changing doses during clinical trials of drugs;

5) The research plan is changed, but the content after the change does not exceed the approved scope, such as reducing the prescription dose group during the clinical trial of the drug.

2. Exit of human genetic resources.

For exit applications for human genetic resource materials that have been approved for exit in the international cooperation approval.

II. Simplify the approval process

1. Apply online

Applicants submit electronic application materials through online platforms.

2. Online prefetching

If the application materials are complete and meet the required form, they will pass the pre-examination. Applicants can print paper materials; if the application materials are incomplete or do not meet the requirements, and do not pass the pre-examination, the applicant shall be notified via the online platform of all the content that needs to be corrected.

3. Delivery of paper application materials

The applicant company shall print the electronic version of the application materials pre-fetched on the Internet using double-sided printing on A4 paper, and print the cover and signature stamp pages using single-sided printing, in one copy, perfect binding, and the attachments are bound sequentially after the application. Submit paper application materials after review and approval by the applicant company.

4. Review and acceptance of paper materials

After receiving the paper application materials submitted by the applicant, the formal examination will be completed within 5 working days. For applications with complete application materials and conforming to the prescribed form, the formal announcement and replacement form will be officially issued. If the application materials are incomplete or do not meet the required form, the application unit shall be returned.

5. Approval decision

The China Human Genetic Resources Management Office will review the application and make a decision on approval or disapproval.

6. Results announced

The approval results will be announced on the website of The Ministry of Science and Technology. If it is not approved, the reasons shall be stated otherwise.

7. Delivery of documents

Send the approval decision to the applicant by post within 10 working days, and publish the details of the post.