China tightens standards, penalties for registration, sale of drugs, vaccines

Seeking to bolster enforcement of its pharmaceuticals market while still accelerating the entrance of innovative drugs and vaccines, the Chinese government has drafted structural changes to its drug and vaccine standards.

The draft changes to the Drug Administration Law and the Vaccine Administration Law were announced in April and apply equally to domestic and imported drugs and vaccines. They increase penalties for violations of pharmaceutical laws. Fines for selling counterfeit drugs will increase by 10 to 15 times their current amounts. And victims of counterfeit drugs will be entitled to seek punitive damages.

If implemented the changes will permit authorized pharmaceutical manufacturers to establish an online presence on registered third-party portals. But online sales of prescription drugs will continue to be restricted.

With regard to vaccines, the government is proposing several key changes to its law, passed just last year, that establishes a national system for inspecting vaccines, and for tracing the production, transportation, storage and use of vaccines. The law also regulates how clinical trials are conducted.

As proposed, the government would offer a priority review to vaccines that meet urgent needs for disease prevention and control. The government would also fund the research and development of new multivalent vaccines.