The State Food and Drug Administration and the Hainan Provincial Government have further promoted the pilot work of real-world data application in the clinical trial of drugs and devices

On December 7, 2022, the State Food and Drug Administration and the Hainan Provincial Government jointly held the fourth meeting of the 2022 Leading Group for the Pilot Work of Clinical Real-World Data Application of Drugs and Medical Devices to summarize the progress of the pilot work of clinical real-world data application since the third meeting of the Leading Group, study and deploy the next step in accordance with the requirements of the party, and help the high-quality development of the biomedical industry in Hainan Free Trade Port and the reform and innovation
of the review and approval system for drugs and medical devices.
Wang Bin, member of the Standing Committee of the Hainan Provincial Party Committee and vice governor, and Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the meeting and delivered speeches
.

 

The meeting pointed out that the report draws a grand blueprint for comprehensively building a modern socialist country and comprehensively promoting the great rejuvenation of the Chinese nation, and makes major arrangements
for promoting the construction of a healthy China, strengthening drug safety supervision, and accelerating the construction of the Hainan Free Trade Port 。 Carrying out the pilot work of real-world data application of drugs and devices in Hainan is a vivid practice of adhering to the people's supremacy, putting people's health in a strategic position of priority development, and improving people's health promotion policies, which is conducive to better serving the strategic positioning given by the state to Hainan to build a pilot zone for comprehensively deepening reform and opening up, an international tourism consumption center and a major national strategic service guarantee zone, and further help the construction and development of Hainan Free Trade Port; It is conducive to deepening the reform and innovation of the review and approval system for drugs and medical devices, and helping to promote the modernization of
Chinese-style drug supervision.

 

The meeting held that since the third leading group meeting was held one year ago, the State Food and Drug Administration and the Hainan Provincial Government have cooperated closely, the pilot work has achieved remarkable results, the clinical real-world data application rule system has been continuously improved, and a number of guiding principles have been issued one after another, basically covering the main application scenarios; The real-world research mechanism has been continuously improved, communication between all parties has become smoother, and various work has become more standardized and efficient; Real-world regulatory science research continues to deepen, and the data research platform has completed the first phase of construction; The review and approval of pilot varieties has continued to advance, and 9 pharmaceutical and device products have been approved for marketing, benefiting more people
.

 

The meeting emphasized that it is necessary to deeply study and implement the spirit of the party, make full use of the major development opportunities of the construction of Hainan Free Trade Port and promote the healthy China strategy, better integrate the clinical real-world data application pilot into the overall situation of national development, further promote the pilot work, and strive to achieve the international leading goal
of real-world data application research of Hainan pharmaceutical devices.

 

The meeting requested that the pilot work should be further advanced in 2023, closely focusing on clinical real-world evidence rules, real-world data platform construction, real-world data quality management and real-world data application in-depth promotion
.
First, it is necessary 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, and constantly summarize the review and approval rules for drug and device evaluation using real-world data, and strive for more products to be approved for marketing
.
The third is to achieve research and innovation leadership, and continuously form high-level new tools, new standards and new methods around the national and Hainan drug and device regulatory needs; Take advantage of the Boao International Conference on Real-World Research on Pharmaceuticals and Devices to strengthen cooperation with global research institutions and contribute Chinese wisdom and strength
to the application of real-world data in global pharmaceutical and device clinical trials.
The fourth is to strengthen the guarantee of organizational resources, give full play to the role of the office of the leading group, further gather resources such as experts and talents, and improve the quality and efficiency
of work.
Fifth, it is necessary to effectively do a good job in project management, incorporate all the work to be carried out into project management, further improve the project management mechanism, establish a regular report, supervision and summary mechanism for projects, keep abreast of the progress of the work, and ensure the orderly and powerful advancement of the work
.

 

The meeting was held by video, and the relevant departments and directly subordinate persons of the State Food and Drug Administration, the heads of relevant departments and bureaus of the Hainan Provincial Party Committee and the provincial government and members of the expert working group participated in the meeting
.