FAQ

Refer to the implementation period of international cooperation in the approval document.

Each preservation unit (organization) shall submit the previous annual report before January 31 of each year.

On the premise of the approved preservation permission, in principle, a legal entity can only carry out one preservation permission activity. During the implementation of the activity, if the duration of the activity and the preservation protocol change, it should apply to the Ministry of Science and Technology for change approval.

Foreign organizations, individuals and institutions established or actually controlled by them (i.e. foreign units) shall not collect or preserve China human genetic resources.

The only collection of the data without containing human genetic resources information is not within the scope of human genetic resources management.

If the collection related to the international cooperation permission involves the category specified by the Ministry of Science and Technology or exceeds the specified quantity, the collection permission shall be applied, and the collection quantity shall be consistent with the total amount of the international cooperation permission application.

No. The project with specific research purposes can be applied for collection. However, if samples need to be stored for a long time, they should be stored in an approved repository.

For clinical image data (such as B-mode ultrasound, CT, PET-CT, nuclear magnetic resonance, X-ray and other image data, intervention, fundus, endoscope, dermatoscope, pathological diagnosis and other image data), and clinical data not involving population gene research (such as blood routine, urine routine, liver and renal function, blood biochemistry and other general laboratory examination information, height, weight and other growth and development indicators, questionnaire information, imaging / image result data, etc.), there is no need to do filing on human genetic resource information open providing or use.

It has obtained the approval of international cooperative research on human genetic resources / the filing of international cooperative clinical trials, and all partners carry out activities in accordance with the cooperation agreement. The information of human genetic resources generated by international cooperative scientific research using China's human genetic resources can be used by both parties without providing data information for the record. If other foreign units participating in the cooperation want to use relevant research data, the Chinese data information owner of both parties shall apply for the external provision or open use of data information for filing.

If the foreign party has no substantive participation in such scientific research, nor obtain relevant data and information, and the research results will not be shared with the foreign party (for example, foreign pharmaceutical enterprises only provide clinical research drugs or some research funding for investigators in medical institutions without sharing the research results), they will not be regulated as international cooperative scientific research carried out by using China's human genetic resources, and there is no need to apply for the permission of international cooperative scientific research.

In accordance with Article 15 of the Regulations on the Administration of Human Genetic Resources, the preservation entity of human genetic resources shall submit the annual report of the previous year to the Ministry of Science and Technology before January 31 of each year, and the preservation activities approved for less than one year shall be submitted together in the next year.