New Rules on China Human Genetic Resources

On March 2, 2022, Human Genetic Resources Administration of China (HGRAC) released the “Frequently Asked Questions on Human Genetic Resources Management”. On March 22, 2022, the Ministry of Science and Technology issued the “Implementation Rules for the Regulations on the Management of Human Genetic Resources (Draft)”.

The two documents involve international research & clinical trial approval, information provision or open use filing, data backup, supervision, and penalties of human genetic resources.

In 2018, AstraZeneca and five others violated China’s human genetic regulation, resulting in clinical data rejected. Read more

For English copies of “Frequently Asked Questions on Human Genetic Resources Management” and “Implementation Rules for the Regulations on the Management of Human Genetic Resources (Draft)”, please contact us or email info@ChinaMedDevice.com.

Circumstances No Longer Need HGRAC Approval

“Human Genetic Resources Management Questions” clarifies the following situations that do not require the filing to human genetic resources office:

1. Only collecting ECG data
2. For international cooperative clinical trials, provide summary reports or trial data to units which are only Chinese entitie
3. Utilizing publicly available human genetic resources data
4. In the clinical trial, the sponsors, CROs and other cooperating parties are all Chinese entities, and only the EDC suppliers are foreign parties.

Ethical Review

“Implementation Rules” provides convenience for conducting multi-center clinical trials, as ethical review exemptions are added for the following situations:

1. All the cooperative research contents of the licensed and filed projects are completed within the territory of China
2. The cooperative contents conform to ethical principles and do not involve major ethical issues
3. Trials exempted from foreign parties’ ethical review pose no or minimal risk to human subjects.

To apply for an exemption from ethical review by a foreign party, an exemption application should be submitted by the foreign partner. If the domestic partner is more than one institution, the domestic lead institution or team leader unit shall submit the exemption application. The Chinese partner should be reviewed by the domestic lead institution or the institutional ethics committee of the team leader to review the reasons and potential risks for the foreign party’s ethical exemption review of the cooperation project. When applying for exemption from ethical review by a foreign party, the authorization document of the foreign party and the review conclusion of the Chinese partner on the reasons for the ethical exemption review and potential risks should be provided.

Security Review

Article 49 of the “Implementation Rules” states that security review is required, and the following information shall be provided to the public for security review:

1. Human genetic resources information of important genetic families
2. Human genetic resources information in specific regions
3. Exome sequencing and genome sequencing information resources for people with more than 500 people
4. Other information that may affect China’s public health, national security, and social interests.

In conclusion, the updated rules on Human Genetic Resources Management (HGRAC) streamlined more on how and when foreign entities go through the application process. China Med Device wrote a white paper on this topic and helped our overseas clients navigate through the filing/application with China HGRAC. Email info@ChinaMedDevice.com to get the HGRAC white paper.