NMPA and Hainan Province Jointly Promoted the Pilot Application of Clinical Real-World Data of Drugs and Devices
On December 28, 2021, the NMPA and the Hainan Province jointly convened the third meeting of the leading group on the pilot application of clinical real-world data of drugs and devices in 2021, to summarize the experience in the pilot application of clinical real-world data and discuss new measures to further promote real-world studies to contribute to the high-quality development of the biomedical industry and the reform of the evaluation and approval system for drugs and medical devices in Hainan Free Trade Port. Wang Bin, Vice Governor of Hainan Province, and Xu Jinghe, Deputy Commissioner of NMPA, attended and addressed at the meeting.
In 2021, NMPA and the Hainan Province have worked together to actively carry out the study and exploration on the collection of real-world evidence and its application in regulatory decision making. Multiple guidelines related to clinical real-world study of drugs and medical devices have been successively issued, research base for drug and medical device regulatory science and key laboratory for real-world study and evaluation in Hainan have been set up and operated, and pilot varieties of drugs and medical devices, such as femtosecond laser system and pralsetinib capsules, have been successively approved for marketing with real-world study data of Boao Lecheng as auxiliary clinical evaluation evidences. The management of drugs and medical devices in urgent clinical need for import has been further regulated, and progress has been made in the trial application of clinical realworld data.
Also, in-depth discussions were conducted in the meeting on further deepening the reform of drug and medical device evaluation and approval system, innovating the drug and medical device regulatory mode of Hainan Free Trade Port, implementing the action plan for drug regulatory science, and exploring new tools, methods and means for the study and application of real-world data.
The meeting was held in the form of videoconferencing, and attended by leaders of relevant departments as well as directly affiliated institutions of NMPA, leaders of relevant departments of Hainan Province, and members of the Expert Working Group.