China’s proposed new Drug Administrative Law (DAL) would significantly strengthen safety requirements for manufacturers of drugs and vaccines, establish a readily accessible repository of drug safety information and increase civil fines for violations.
According to a draft of the law, drug manufacturers will be required to implement strict systems to trace the production of pharmaceuticals and vaccines from start to finish. The law makes holders of marketing authorizations responsible for the safety and efficacy of their products, from research to manufacturing to market.
The draft law also includes measures to speed the drug approval process. Specifically, under the draft law, regulatory authorities will speed approvals for clinical trials of a new drug to under 60 days from the date of application.