On November 22, the 6th Meeting of the Leading Group on the Pilot Application of Clinical Real-World Data was held in Hainan Boao Lecheng. Xu Jinghe, Party member and Deputy Commissioner of the National Medical Products Administration (NMPA), and Gu Gang, Vice Governor of the People's Government of Hainan Province, attended the meeting and delivered a speech.
The meeting reviewed the achievements of the pilot work in 2024, which included the approval of 4 drugs and medical devices with urgent clinical needs, the release of 2 real-world guidelines, and the initiation of over 20 regulatory science projects on real-world studies. The meeting acknowledged that the pilot work had made steady progress and achieved significant results.
The meeting emphasized the need for comprehensive and systematic planning for the next 3-5 years to promote the development of real-world studies. It called for increased efforts in accelerating product approvals, improving the regulatory framework, strengthening data platform construction, and deepening regulatory science research, with the goal of advancing real-world study to a new stage.
During the meeting, Xu attended the 3rd Boao International Conference on Real World Studies of Medical Products and conducted field research. The officials in charge of relevant departments of NMPA and relevant departments of the People's Government of Hainan Province also participated in the meeting.
(From: National Medical Products Administration website 2024-11-23)