A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Updates Made to Rules Governing Human Genetic Resources in China

China has recently made updates to its rules governing human genetic resources, which have been in place since 1998. The new regulations, which were announced in June 2019 and came into effect on July 1, 2019, aim to strengthen the management and protection of human genetic resources in the country.

The new rules require that all research institutions and companies that collect, store, and use human genetic resources must register with the National Health Commission (NHC) and obtain a license. The license will be valid for five years and can be renewed upon expiration. The NHC will also establish a national database of human genetic resources to monitor their use and prevent unauthorized access.

The regulations also require that researchers obtain informed consent from donors before collecting their genetic material. The consent form must clearly state the purpose of the research, the potential risks and benefits, and the rights of the donor. The regulations also prohibit the collection of genetic material from minors or individuals who are unable to give informed consent.

The new rules also address the issue of intellectual property rights. Researchers who discover new genes or genetic variations must disclose their findings to the NHC and obtain permission before applying for patents. The regulations also prohibit the transfer of genetic resources overseas without approval from the Chinese government.

The updates to China’s rules governing human genetic resources come at a time when the country is rapidly advancing in the field of genetics. China has invested heavily in gene editing technology, with researchers making breakthroughs in areas such as CRISPR-Cas9 gene editing and gene therapy. However, these advances have also raised ethical concerns, particularly in light of the controversy surrounding the birth of genetically edited babies in China in 2018.

The new regulations aim to address these concerns by ensuring that human genetic resources are managed and used responsibly. They also reflect China’s commitment to international norms and standards for the protection of human genetic resources. The updates have been welcomed by many in the scientific community, who see them as a positive step towards ensuring the ethical use of genetic resources in China.

In conclusion, the updates made to China’s rules governing human genetic resources are an important development in the field of genetics. They reflect China’s commitment to responsible research and the protection of human rights. The regulations will help to ensure that genetic resources are used ethically and responsibly, while also promoting innovation and scientific progress.

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