On July 15, the first communication meeting in 2021 for the pilot work of real-world data application of Hainan Pharmaceuticals was held in Haikou, Hainan. The conference was jointly sponsored by the Drug Evaluation Center of the State Drug Administration, the Hainan Provincial Drug Administration and the Boao Lecheng International Medical Tourism Pilot Zone Administration, and hosted by the Hainan Real World Data Research Institute.

The purpose of the meeting is to strengthen communication and exchanges with enterprises and medical institutions of real-world research drug pilot varieties, to study and discuss the problems and countermeasures existing in the research of pilot varieties, to discuss the paths and measures to carry out real-world research on children's drugs and traditional Chinese medicine, and to further promote real-world research. Research work is carried out.

Zhou Siyuan, deputy director of the Drug Evaluation Center of the State Food and Drug Administration, Yang Zhimin, director of the first department of chemical medicine clinical department of the State Food and Drug Administration, Han Ling, director of the clinical department of traditional Chinese medicine, Xie Songmei, deputy director of the second department of chemical medicine clinical department, and deputy director of the Department of Statistics and Clinical Pharmacology Wang Jun, Secretary of the Party Committee and Director of the Boao Lecheng Pioneering Area Administration Gu Gang, Li Zhiping, head of the Hainan Provincial Drug Administration, Liu Hongtao, Zhu Ning, Li Yunda, deputy directors of the Hainan Provincial Drug Administration, Boao Lecheng Pioneering Area Administration Lv Xiaolei and Fu Zhu, deputy directors, Li Lijing, executive deputy director of the Medical and Drug Administration of Lecheng Pioneer District, Chen Pingyan and Qu Jia, executive directors of Hainan Real World Data Research Institute, as well as experts and scholars in the fields of children's medicine clinical, traditional Chinese medicine clinical, statistics and other fields Attend a meeting.
At the plenary meeting, Gu Gang said in his speech that under the active planning and vigorous promotion of the Drug Registration Department of the State Administration, the Drug Evaluation Center of the State Food and Drug Administration, and the Hainan Provincial Food and Drug Administration, Lecheng's real-world research has made breakthroughs. In the second half of this year, the real-world data research platform will be launched, which means that Lecheng's real-world research work will take another big step forward. Lecheng has become a very important channel for the registration of international innovative pharmaceutical devices in China. It is hoped that international pharmaceutical and device companies can actively participate and jointly promote the development of real-world research in Lecheng.

Li Zhiping said that the pilot work of real-world drug research in Hainan is an exploration of crossing the river by feeling the stones. With the collaboration of scholars, research institutions and enterprises, the Lecheng Pioneer Zone, as a pioneering place for real-world research in my country, has become a bridgehead for multinational pharmaceutical companies to accelerate their entry into the Chinese market.

In his speech, Zhou Siyuan affirmed the achievements of Lecheng's real-world research and believed that with the joint efforts of all parties, Lecheng has built a good platform for promoting real-world research and has become a new highland for my country's drug science supervision. Use the Lecheng platform to provide data collection services, encourage or promote the simultaneous R&D registration of multinational pharmaceutical companies in China, and make China's contribution to global real-world research.

At the meeting, Li Yunda introduced the relevant working mechanism of Lecheng's real-world research.

Yang Zhimin (above) and Wang Jun (below) explained

Yang Zhimin and Wang Jun respectively gave an introduction to "Technical Guidelines for Real-World Research Supporting the Development and Review of Children's Drugs (Trial)" - Exploration of Using RWS to Support RWE to Support the Expansion of Children's Applications World Evidence Applications" theme report. After the first communication meeting, the Drug Evaluation Center of the State Food and Drug Administration hosted the real-world research seminar on children's medication and the real-world research seminar on traditional Chinese medicine respectively.

At the Symposium on Real World Research on Pediatric Drugs, the participants focused on the exploration of using RWE to support the expansion of children's applications. Research and discussion on the variety determination, research methods, and research plans of common situations of children's drug use, such as "expanding the scope of application)", and discuss in-depth research paths and strategies for children's drug use in the real world.

At the real-world research seminar on traditional Chinese medicine, the participants explained the three aspects of traditional Chinese medicine theory, human experience and clinical trials included in the construction of the "three-in-one" review evidence system, and pointed out that patients should be used in clinical research of traditional Chinese medicine. selected as the center. The core of "three combinations" lies in human experience, and the core of human experience lies in the summary of high-quality clinical trials of traditional Chinese medicine, and in-depth discussion of the path of collecting and sorting out human experience by using real-world data methods under the "three combinations" system and strategy.

Also participating in this meeting were relevant personnel from the Drug Evaluation Center of the State Food and Drug Administration, the Hainan Provincial Food and Drug Administration, and the Boao Lecheng Administration, as well as representatives of data companies, representatives of children's drug/traditional Chinese medicine companies, and representatives of medical institutions.