China's Drug Regulator Prioritizes Domestic Innovation and Faster Access to Foreign Drugs

China's National Medical Products Administration (NMPA), the country's top drug regulator, has announced its commitment to accelerating the development and market access of innovative drugs, both domestically produced and foreign. This initiative aims to address public demand for novel treatments while fostering domestic innovation in the pharmaceutical industry.

The NMPA reported approving 31 innovative drugs and granting market clearance to 46 innovative medical devices between January and August 2023. This represents a significant increase compared to the same period last year, demonstrating the agency's focus on promoting domestic research and development. Additionally, Chinese-developed novel medicines are gaining recognition in the global market, with some achieving market registration overseas.

Recognizing the importance of international collaboration, the NMPA is also expediting the introduction of novel foreign drugs to the domestic market. This includes streamlining the review process for innovative medications, reducing the approval time from 60 to 30 working days in select regions. Furthermore, the agency is promoting international multi-center clinical trials and facilitating simultaneous research and review of global drugs in China.

The NMPA is actively exploring segmented production of biological products and encouraging international drugmakers to transfer manufacturing capacity of novel and high-end medical products to China. This will further strengthen the domestic pharmaceutical industry and ensure access to cutting-edge treatments. Additionally, the agency continues to prioritize strict supervision of drug production, conducting over 21,000 spot checks on drug manufacturers in the first eight months of 2023, with a high pass rate of 99.43%.

Overall, the NMPA's initiatives demonstrate a comprehensive approach to fostering innovation, improving access to novel treatments, and strengthening the Chinese pharmaceutical industry.