"If drug regulatory science is to assume historical responsibilities, it must adhere to problem-oriented, goal-oriented, and demand-oriented, focus on the five themes of'innovation, quality, efficiency, system, and competence' in the field of drug regulatory, in accordance with scientific, legalized, international, Modernization requirements, accelerate the modernization of the drug regulatory system and regulatory capabilities." Recently, at the inaugural meeting of the Institute of Drug Regulatory Sciences of Shenyang Pharmaceutical University, Xu Jinghe, deputy director of the State Drug Administration, said.

In order to accelerate the modernization of the drug regulatory system and regulatory capacity, in April 2019, the State Food and Drug Administration launched the China Drug Regulatory Scientific Action Plan and identified the first batch of nine key research projects.

Focus on long-term service supervision

Since its establishment, the State Food and Drug Administration has always resolutely implemented the "four strictest" requirements, adhered to the people-centered development thinking, and advanced various tasks in an orderly and vigorous manner, and continuously achieved new results. At the same time, my country's drug supervision industry also presents the stage characteristics of the coexistence of quality safety and quantitative safety risks, the coexistence of systemic risks and individual violations of laws and regulations, and the coexistence of historical problems and new technological challenges. There are insufficient and unbalanced development of the pharmaceutical industry. There are many hidden dangers of drug safety risks, and there are still many problems such as shortcomings in the legal construction of drug supervision, scientific decision-making, and supervision capacity building.

According to the scientific action plan of drug supervision, the scientific research of drug supervision in China will be based on the actual situation of drug supervision, aiming at the outstanding problems existing in the supervision of drugs, medical devices and cosmetics in the new period, through innovative supervision tools, standards and methods, further enhance the scientificity, foresight and adaptability of supervision work, and after 3-5 years of efforts, formulate a number of supervision policies, review technical guidelines, inspection and inspection standards, etc, effectively solve the outstanding problems that affect and restrict drug innovation, quality, and efficiency, and accelerate the modernization of the drug regulatory system and regulatory capabilities.

The scientific action plan for drug supervision defines three key tasks: to build 3 to 5 scientific research bases for drug supervision; to launch a number of key scientific projects for supervision; and to launch a number of new systems, new tools, new standards and new methods for drug review and supervision.

A total of nine key research projects on drug regulatory science were launched in the first batch, they are research on technical evaluation and supervision system of cell and gene therapy products, research on safety evaluation and quality control of nano drugs, research on safety evaluation of traditional Chinese medicine based on clinical practice of traditional Chinese medicine, research on safety monitoring and evaluation methods of post-marketing drugs, research on technical evaluation of drug combination products, research on safety and effectiveness evaluation of artificial intelligence medical devices, scientific research on supervision of new materials for medical devices, and methodological research on clinical evaluation of real-world data for medical devices. Study on the safety evaluation method of cosmetics.

Solve problems based on reality

On April 26, the Institute of Medical Device Regulatory Science of Sichuan University was established as the first medical device regulatory scientific research base of the State Food and Drug Administration.

On June 27, the State Food and Drug Administration signed a cooperation agreement with the China Academy of traditional Chinese Medicine and Beijing University of traditional Chinese Medicine to establish a scientific research center for the supervision of traditional Chinese medicine and a scientific research institute for the supervision of traditional Chinese medicine.

On November 23, the Institute of Drug Regulatory Science of Shenyang Pharmaceutical University was officially inaugurated as the drug regulatory scientific research base of the State Drug Administration......

A few days ago, the State Food and Drug Administration approved South China University of Technology as a scientific research base for medical device supervision of the State Food and Drug Administration.

The reporter learned that in view of the outstanding problems existing in the supervision of drugs, medical devices and cosmetics in the new era, the State Food and Drug Administration has actively carried out regulatory scientific research cooperation with universities and scientific research institutions. In addition to the above-mentioned universities, the State Food and Drug Administration has also cooperated with the Chinese Academy of Sciences, Tsinghua University, Shandong University, and Beijing Technology and Business University.

As the first medical device regulatory scientific research base, the Medical Device Regulatory Research Institute of Sichuan University actively cooperated with the State Food and Drug Administration. In a short period of 8 months, it carried out 4 key projects: technical evaluation research on pharmaceutical combination products, safety and effectiveness evaluation research on artificial intelligence medical devices, new medical device regulatory scientific research on new materials and methodology research on real-world data for clinical evaluation of medical devices. In-depth study of basic theories of regulatory science, at the same time, we continue to explore the application of regulatory science.

Tang Zhonglan, assistant to the dean of the Institute of Medical Device Regulatory Science of Sichuan University, told reporters that the institute is actively organizing research on key technologies for the safety and effectiveness evaluation of induced biomaterials and products, research on key technologies for the safety and molecular markers of new implanted biomaterials, and Biomedical materials testing and evaluation, clinical research and service one-stop platform construction, etc.

On June 27, at the unveiling ceremony of the Chinese Medicine Regulatory Science Research Center and the Chinese Medicine Regulatory Science Research Institute, Li Li, secretary of the Party Group of the State Food and Drug Administration, emphasized that to deepen the cooperation in the scientific research of Chinese medicine supervision, it is necessary to promote the development of Chinese medicine supervision from a political perspective. Improve the safety governance system of Chinese medicine, strengthen the theoretical and practical innovation of Chinese medicine supervision, and build a Chinese medicine registration review evidence evaluation system that combines Chinese medicine theory, human experience and clinical research, establish a scientific standard system for traditional Chinese medicine and a post-marketing regulatory system to promote the regulation of traditional Chinese medicine to a new level.

Huang Luqi, Dean of the Chinese Academy of Chinese Medical Sciences, said that traditional Chinese medicine is different from chemical medicine. The whole process from planting and production to final clinical application has its own characteristics, and its supervision is more special and complicated. "The research and development of traditional Chinese medicine supervision science is the requirement of the country, the needs of the people and the expectations of the Chinese medicine industry. It also provides a'Chinese program' for the supervision of traditional medicines in the world '." Huang Luqi said.

According to the cooperation agreement between the State Food and Drug Administration and the China Academy of traditional Chinese Medicine and Beijing University of traditional Chinese Medicine, the State Food and Drug Administration and the China Academy of traditional Chinese Medicine have set up a scientific research center for the supervision of traditional Chinese medicine, which will cooperate in solving the problems of evaluation and supervision of traditional Chinese medicine, policy research on promoting the innovation of traditional Chinese medicine, and strengthening the training of scientific personnel in the supervision of traditional Chinese medicine, cooperation in the education of Chinese medicine supervision science, cooperation in the training of Chinese medicine supervision talents, and the construction of a data-centric Chinese medicine wisdom supervision model.

At the inaugural meeting of the Institute of Drug Regulatory Science of Shenyang Pharmaceutical University, the relevant person in charge of Shenyang Pharmaceutical University said that Shenyang Pharmaceutical University will carry out in-depth research on the basic theory of drug regulatory science around the whole life cycle of drugs, actively develop a series of new tools, new standards and new methods, promote the construction of regulatory science disciplines, and train talents in the field of regulatory science, provide all-round support for the top-level design and future implementation of the national drug regulatory scientific strategy.

China's drug regulatory scientific research is accelerating.