The Measures issued by the NMPA introduce a structured framework for the protection of undisclosed pharmaceutical trial data submitted in China, thereby strengthening the regulatory regime governing data exclusivity within the pharmaceutical sector. The system provides for protection periods of up to six years for innovative drugs, while establishing differentiated rules applicable to modified drugs, new indications, generics, and biologics, depending on the nature of the application.
The reform is designed to reinforce China’s pharmaceutical regulatory framework by promoting innovation while maintaining a balance with timely access to medicines. It is expected to have significant implications for pharmaceutical companies and international operators, particularly in relation to market entry strategies, regulatory exclusivity planning, and broader lifecycle management in the Chinese market.