China’s Biosecurity Law, which comes into force on 15 April 2021, is the new framework for the nearly one hundred laws, regulations and rules already in place in this area. It contains regulations on a wide range of topics – including the prevention and control of epidemic diseases, the establishment of a risk monitoring and early warning system, track-and-trace mechanisms, safety management of biological laboratories and of human genetic resources.
The new law introduces a licensing and registration system for activities related to biotechnology research and development. Prior to approval, all activities will be classified as high, medium or low risk – depending on the risk these activities pose to public health, industry, agriculture and the ecosystem. Activities classified as medium or high risk can only be carried out in China after approval and registration by a China-based company.
The new regulations regarding the import of controlled essential equipment and special biological agents affect animals, plants, microbes, biotoxins and other biologically active substances. While private individuals are not allowed to import controlled essential equipment or special biological agents, companies wishing to import a high-risk biological agent for the first time must first obtain a permit from the relevant authorities.
European biotech companies with a branch in China should carefully study the new regulations on research, development and application of biotechnology as well as on the procurement of controlled essential equipment and special biological agents. The higher penalties for illegal behavior should not be ignored either. For example, R&D activities that violate the law can be fined RMB 1 to 10 million, and all tools and materials used, as well as illegal profits, will be confiscated.