On December 7, 2022, the National Food and Drug Administration and the Hainan Provincial Government jointly held the fourth meeting of the 2022 Leading Group for the Clinical Real World Data Application Pilot Work of Drugs and Medical Devices, summarizing the progress of the clinical real world data application pilot work since the third leading group meeting, and studying and deploying the next steps to meet the requirements of the 20th National Congress of the Communist Party of China, Assist in the high-quality development of the biopharmaceutical industry and the reform and innovation of the drug and medical device review and approval system in Hainan Free Trade Port. Wang Bin, member of the Standing Committee of the Hainan Provincial Party Committee and Minister of the Propaganda Department, Vice Governor of the Provincial People's Government, and Xu Jinghe, member of the Party Group and Deputy Director of the National Drug Administration, attended the meeting and delivered speeches.

The meeting pointed out that the report of the 20th National Congress of the Communist Party of China outlined a grand blueprint for comprehensively building a socialist modernized country and promoting the great rejuvenation of the Chinese nation. It made significant arrangements for promoting the construction of a healthy China, strengthening drug safety supervision, and accelerating the construction of Hainan Free Trade Port. Carrying out the pilot work of clinical real world data application in medicine and equipment in Hainan is a vivid practice of adhering to the principle of putting the people first, prioritizing the development of people's health, and improving policies to promote people's health. It is conducive to better serving the strategic positioning given by the country to Hainan's construction of a comprehensive deepening reform and opening up pilot zone, an international tourism consumption center, and a major national strategic service guarantee zone, and further assisting the construction and development of Hainan Free Trade Port; It is conducive to deepening the reform and innovation of the drug and medical device review and approval system, and helping to promote the modernization of Chinese style drug supervision.
The meeting believes that since the convening of the third leadership group meeting for one year, the National Drug Administration and the Hainan Provincial Government have closely cooperated, and the pilot work has achieved significant results. The clinical real world data application rule system has been continuously improved, and multiple guiding principles have been successively released, basically covering the main application scenarios; The real world research mechanism is constantly improving, communication between all parties is smoother, and all work is more standardized and efficient; Real world regulatory scientific research continues to deepen, and the data research platform has completed the first phase of construction tasks; The review and approval of pilot varieties continues to advance, and 9 pharmaceutical and mechanical products have been approved for listing, benefiting more people.
The meeting emphasized the need to deeply study and implement the spirit of the 20th National Congress of the Communist Party of China, fully utilize the major development opportunities of the construction of Hainan Free Trade Port and the promotion of the Healthy China strategy, better integrate the clinical real world data application pilot into the overall national development situation, deepen the pilot work, and strive to achieve the international leading goal of Hainan Pharmaceutical Real World Data Application Research.
The meeting requested that further pilot work be carried out in 2023, closely focusing on the construction of clinical real world evidence rules, real world data platforms, real world data quality management, and the application of real world data. One is to accelerate the improvement of policy systems and basically complete the task of formulating policy rules for clinical real-world data research. The second is to continue to do a good job in product review and approval, continuously summarize the review and approval laws of using real-world data to conduct pharmaceutical equipment evaluation, and strive for more products to be approved and launched. The third is to achieve research and innovation leadership, and constantly form high-level new tools, standards, and methods based on the regulatory needs of the country and Hainan's pharmaceutical equipment; Taking advantage of the Boao International Conference on Real World Research in Pharmaceutical Devices, we aim to strengthen cooperation with global research institutions and contribute Chinese wisdom and strength to the application of global clinical real world data in pharmaceutical devices. The fourth is to strengthen the guarantee of organizational resources, fully leverage the role of the leadership group office, further gather resources such as experts and talents, and improve work quality and efficiency. The fifth is to effectively carry out project management, incorporate all proposed work into project management, further improve project management mechanisms, establish regular reporting, supervision, and summary mechanisms for projects, timely understand work progress, and ensure orderly and effective progress of work.
The meeting was held through video format, with the participation of relevant departments, bureaus, and directly affiliated units of the State Food and Drug Administration, academician Luo Qingming of the Chinese Academy of Sciences, leaders of pilot member units in Hainan Province, and members of the expert working group.