The Ministry of Science and Technology of the People's Republic of China released the Safety Management Regulations for Biotechnology Research and Development (Draft for comments) ("Draft") on 11 March 2019. The Draft is open to public comments until 9 April 2019.
Under the Draft, Biotechnology Research and Development ("Biotech R&D") refers to any scientific research or technology development activity conducted in order to research, utilise or transform organisms. In the event that an experimental activity involves highly pathogenic microbes with human-to-human or animal-to-animal transmission, genetically modified crops or plants, or new biomedical technologies, other relevant laws and regulations should apply. According to the Draft, Biotech R&D will be encouraged under the condition that it does not harm national biological security, public interests nor breaches the principles of ethics. The State Council of the PRC ("State Council") is going to draft a specific list accordingly in terms of prohibited Biotech R&D activities.
Biotech R&D activities will be classified into three levels (high, moderate or low risk) in accordance with their actual or potential risks to human health, ecosystems, national biological security, morals and ethics. The State Council is going to draft a separate list for high-risk and moderate-risk Biotech R&D activities. The high-risk Biotech R&D activities must meet the following preconditions and obtain prior approval from a provincial-level government:
- Biotech R&D activities can only be conducted by legal persons registered within the PRC ("Conductors");
- Conductors must have a research plan, including but not limited to, the purpose, details, personnel, technical approaches and scientific bases;
- Conductors must have a risk-reduction plan, including but not limited to, any potential risks, detailed measures to reduce those risks and safety measures;
- Conductors must have an emergency plan in response to any potential accidents;
- The Biotech R&D activity should pass internal risk evaluation carried out by the Conductor;
- Conductors must establish a Biotech Security Commission;
- Conductors must establish a safety management department;
- Conductors must have a safety management system and qualified sites, equipment, facilities and personnel; and
- Other preconditions as prescribed by law and regulations.
The Biotech Security Commission should be responsible for implementing the risk evaluation, drafting the risk-reduction plan, tracking the approved Biotech R&D activities and assist with staff training, amongst others. The Conductor should register its Biotech Security Commission with the provincial-level government within 30 days of its establishment.
The Draft also provides for certain risk-reporting requirements, supervision measures and legal liabilities for non-compliance.
To read the full text of the Draft (in Chinese only) please click here.