Jiangsu: Promote the pilot reform of optimizing the process of drug supplementary application review and approval.

The General Office of the People's Government of Jiangsu Province recently issued the "Several Policy Measures on Promoting Comprehensive Drug and Medical Device Regulatory Reform to Promote High-quality Development of the Pharmaceutical Industry." It mentioned striving to carry out national pilot reforms. Promote the reform pilot of optimizing the review and approval process for supplementary drug applications, and reduce the review time for supplementary applications that require verification and testing from 200 working days to 60 working days. Promote the segmented production reform pilot of biological products and explore cross-border segmented production supervision. Strive to optimize the pilot review and approval process of innovative drug clinical trials, and reduce the review and approval time from 60 working days to 30 working days. Strive for high-level medical institutions to independently develop and use diagnostic reagents that are not yet available in the domestic market. Strive for the pilot review of generic drugs to support the accelerated registration and listing of first generics and improve the quality of generic drugs. Explore the pilot of cross-border commissioned production of medical devices. Strive to pilot foreign-invested enterprises in the free trade zone to engage in the development and application of human stem cells, gene diagnosis, and treatment technologies and use them for product registration and production.