DIA Europe 2024

A New Era of Drug R&D in China China Regulatory Agency NMPA made a stride step in improving its regulatory environment and ecosystem since the introduction of the regulatory reform and becoming an ICH member and of the ICH Management Committee: the review timeline is reduced significantly, and the number of approved innovative medicines increased year by year, the drug lag issue has been resolved significantly. Now, NMPA has been moving to further implementation of ICH and contribution to ICH new guideline development, engaging as a formal member of PIC/s, and seeking regulatory modernization by leveraging new technology and data science into regulatory system and introducing of advanced emerging regulatory science and advanced regulatory measures in review farmwork, such as: RWE in regulatory decision making, Cell & Gene therapy (particularly CAR-T), Orphan Drugs, Patient Focused Drug Development, DCT, ePI and AI in drug R&D, pediatric drug development, etc. All these initiatives are embedded in an ecosystem to move forward for a new era of drug R&D in China. In this China townhall session, we will hear 2 speakers' from CDE and Tsing Hua University to give the in-person presentation, and follows a panel discussion, the panelist including speakers and additional panelist from CDE and industry to cover these hot topics.