China’s State Council promulgated the Regulations on the Administration of Human Genetic Resources

On June 10, the State Council promulgated the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China", which will take effect on July 1, 2019.

The “Regulations on the Administration of Human Genetic Resources of the People's Republic of China” strengthened the management and supervision of human genetic resources in China on the basis of the “Interim Measures for the Administration of Human Genetic Resources” formulated in 1998.

CIRS summarizes the following points:

◆ Increased the intensity of protection. The Regulations stipulate that China conducts a survey on human genetic resources and implements a declaration and registration system for important genetic families and human genetic resources in specific regions. Foreign organizations and organizations established or controlled by foreign organizations or individuals to carry out scientific research activities using Chinese human genetic resources shall be carried out in cooperation with China. Where information on human genetic resources is provided or used openly, it shall be filed and submitted for backup of information, which may affect China's public health, national security and social public interests, and shall pass security review.

◆ Promote the rational use of human genetic resources. The regulations stipulate that China supports the rational use of human genetic resources for scientific research, development of biomedical industry, improvement of diagnosis and treatment technologies, improvement of biosafety support capabilities, and improvement of health protection standards.

◆ The use of human genetic resources has been strengthened. The Regulations stipulate that the collection, preservation, utilization and external provision of Chinese human genetic resources shall not endanger the public health, national security and social public interests of China, and shall conform to ethical principles, protect the legitimate rights and interests of resource providers, and abide by corresponding technical norms. To carry out biotechnology research and development activities or clinical trials, researcher shall abide by relevant biotechnology research regulations, clinical application management regulations, administrative regulations and relevant state regulations.

◆ Optimized service and supervision. The regulations stipulate that the administrative department of science and technology should optimize and improve services in facilitating the use of the Internet for examination and approval, filing matters, and strengthen supervision. At the same time, the relevant legal responsibilities have been improved and penalties have been increased.

The Human genetic resources management filing circumstances

◆ Collection, sale, export, etc. of Chinese human genetic resources engaged in China

◆ Applicable to human genetic resources in China, including important genetic families and human genetic resources in specific regions

Filing applicant requirement

◆ Legally established legal entities in China

Human genetic resources management filing process

Depending on the circumstances, if it is not filed as required or violates relevant laws, it will be fined between 500,000 and 5 million.

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Ÿ China NMPA Medical Device Filing and Registration Consulting

Ÿ Clinical Trial Consulting

Ÿ Medical Device GMP System Assessment

Ÿ China Medical Device Regulation Training

Ÿ Guideline: Medical Device Registration in China

Ÿ Annual Report: Medical Device Market in China