In order to implement the spirit of the instructions of the State Food and Drug Administration and the Hainan Provincial Party Committee and Government, on March 21, the 2021 Hainan Provincial State Food and Drug Administration Drug and Medical Device Regulatory Scientific Research Base Work Symposium and the President of Hainan Real World Data Research Institute The first working meeting was held in the Boao Lecheng Pioneer Zone to discuss the construction of a regulatory science base and research institute, and contribute Hainan's wisdom and Lecheng's strength to the development of my country's regulatory science and health undertakings.

In November 2020, the State Food and Drug Administration awarded the Hainan Real World Data Research Institute the "State Drug Administration Drug and Medical Device Regulatory Scientific Research Base" brand. The base aims to give full play to the advantages of medical devices and real-world data resources that are urgently needed for clinical use in the Boao Lecheng Pioneer Area, focus on real-world research, and further promote the use of real-world data for drug and medical device registration and regulatory decision-making. Explore new paths for the reform of the approval system, and build the Lecheng Pioneer Zone into a real-world data research platform with an international advanced level.

In the morning, Li Zhiping, member of the party group, deputy director of the Provincial Market Supervision Bureau, and the main person in charge of the Provincial Food and Drug Administration, presided over the 2021 work symposium on the scientific research base for drug and medical device supervision of the Hainan Provincial State Food and Drug Administration. Gu Gang, Secretary of the Party Committee and Director of the Lecheng Pilot Area Administration, briefed the recent Lecheng Administration and the Provincial Food and Drug Administration to the State Food and Drug Administration to apply for policies to promote real-world research. On behalf of the base secretariat, Fu Zhu, member of the party committee and deputy director of the Lecheng Pilot Area Administration, reported the work progress of the base and the research institute and the next work plan. Shao Haiya, Director of the Provincial Health and Health Commission, introduced the working concept of the Real World Research Hospital Alliance.

The delegates closely focused on the first Boao Lecheng International Real-World Data Conference on Pharmaceuticals and Devices planned to be held this year, the first batch of domestic real-world research doctoral and postgraduate training jointly carried out by the Institute and Hainan University, consolidate the medical infrastructure and discipline construction in the park, and carry out real-world research. World data application and research topics, the construction of clinical real world data research platform in Hainan Province and the real world hospital alliance, as well as the problems to be solved by the research base and the next work plan, conduct in-depth discussions, and put forward opinions and suggestions.

The clinical real-world data application pilot is an important part of the national drug regulatory scientific action plan, and it is a major institutional innovation in Hainan to promote the construction of a free trade port. The delegates unanimously said that the unique clinical urgent need for imported pharmaceutical equipment and real-world research licensing policy in the Lecheng Pioneer District has attracted the attention of many international pharmaceutical equipment manufacturers and well-known domestic academicians and experts. Driven, with talent training as the starting point, with the promotion of the registration and listing of international innovative pharmaceutical products as the phased goal, with the ultimate goal of helping the reform of China's drug review and approval system, gathering the resources of the national expert team, and building the regulatory science base and research institute into a An open and inclusive platform and new highland in the field of real-world research in China, promoting real-world research with high quality and high efficiency.

In the afternoon, Academician Luo Qingming, President of Hainan University, Deputy Secretary of the Party Committee and Honorary Dean of the Hainan Real World Data Research Institute, presided over the first working meeting of the Dean of the Institute in 2021. At the meeting, the dean of the research institute, the representatives of the technical committee members, the leaders of the Provincial Food and Drug Administration, the heads of relevant departments and directly affiliated units focused on the technical problems of the real-world data research platform, the problems and solutions in the research of real-world pilot varieties, Discuss the feasible path to carry out real-world research on traditional Chinese medicine. The meeting reviewed and approved the management system of Hainan Real World Data Research Institute. Also present at the meeting were Zhang Wei, the second-level inspector of the Provincial Health and Health Commission, Liu Hongtao, Zhu Ning, and Li Yunda, deputy directors of the Provincial Food and Drug Administration, the heads of relevant departments and directly affiliated units of the above-mentioned units, as well as the dean of the research institute and members of the academic committee. There are more than 40 representatives, experts and scholars.