From September 14 to 15, the Second China Drug Regulatory Science Conference (2017) was held in Beijing. The theme of the conference is "quality, safety, and innovative development". Jiao Hong, the Deputy Director of China Food and Drug Administration (CFDA), attended the conference and gave a keynote speech.
In her speech titled “Scientific Supervision, Reform and Innovation of Medical Devices”, Jiao Hong pointed out that the scientific decision-making was an important basis for scientific supervision, deepening the reform of review and approval system was a necessity of scientific supervision, strengthening post-market supervision was a significant manifestation of scientific supervision, and promoting information disclosure was an important means of scientific supervision.
She also emphasized that the food and drug safety issue was vital to livelihood and public safety. The Party Central Committee and the State Council attached great importance to this issue, emphasizing that the most rigorous standard, the strictest regulation, the most severe punishment, and the most serious accountability should be implemented to ensure the food and drug safety. It fully reflected the importance of food and drug supervision in the work of the Party and the government, and further showed the determination of the Party Central Committee and the State Council to ensure the food and drug safety for the people. It is an important guarantee for food and drug supervision.
In recent years, the supervision of medical devices has been strengthened, the reform of medical devices review and approval system further promoted, the quality and efficiency of the review and approval continuously improved, and the law and regulation system of medical devices basically taken shape. The CFDA, by focusing on key issues of the supervision, weak points of the quality management and risk points of potential problems, and addressing the management of high-risk products and key parts of the medical devices production, developed targeted risk prevention and control catalog and took corresponding regulatory measures. In the meantime, the CFDA has made greater effort to enhance information disclosure, timely responding to social concerns, enhancing the interpretation of laws and regulations and supervision measures and policies, continuously expanding the channel of information release, and integrating the information release work into the whole process of supervision.
Jiao Hong said at a meeting on July 19, the central leading group for comprehensively deepening reform passed the Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices, proposing new requirements for further deepening the reform. The CFDA will continue to encourage the innovation of medical devices research and development in accordance with the reform requirements, and make it further meet the needs of clinical use. Also, the CFDA will build a high-level inspection team composed mainly of full-time inspectors and with part-time inspectors as the supplement. The CFDA will also make full use of the great service functions of government websites to improve the quality of information release, enhance the initiative and timeliness of policy interpretation, and promote the sharing of information resources.
At the conference, representatives of the pharmaceutical enterprises read the enterprise integrity declaration of “being law-abiding and honest”. In the main part of the forum, officials from the CFDA, the National Health and Family Planning Commission, the Ministry of Human Resources and Social Security, and the Ministry of Industry and Information Technology, together with the domestic and foreign experts and scholars, had a discussion and made interpretation of the hot and difficult issues of drug regulatory reform measures and innovation and development of medicine. The conference also set up four thematic forums, including the “Regulation Concepts and Practice Innovation of Food and Drug” forum, the “Regulatory Reform and Industrial Development of Biological Products” forum, the "Regulatory Reform of Drug Circulation and Promoting the Healthy Development of the Industry” forum, and the “Policy Reform and Technological Innovation of Medicine Packaging Materials and Pharmaceutical Adjuvant” forum. Experts and scholars from the food and drug supervision authorities, pharmaceutical production enterprises, medical colleges and universities and medical institutions, had a discussion of regulation concepts and practice innovation, and the healthy development of the pharmaceutical industry.
This conference is hosted by China Society for Drug Regulation and sponsored by China Health-Media Group, Ltd. Nearly 1,300 persons attended the conference. They are: academicians from the Chinese Academy of Engineering Hou Huimin, Ning Guang, Liu Changxiao, Zhang Xingdong; officials from Department of Consumer Goods Industry of Ministry of Industry and Information Technology, Department of Science and Education of National Health and Family Planning Commission, Social Security Research Institute of Ministry of Human Resources and Social Security, General Office of CFDA, Department of Medical Device Registration, Department of Medical Device Supervision, and Inspection Bureau; officials and persons in charge from Chinese Pharmacopoeia Commission, Center for Food and Drug Inspection of CFDA, National Committee on the Assessment of Protected Traditional Chinese Medical Products, Information Center, Certification Center for Licensed Pharmacist of CFDA, China Health-Media Group, Ltd., China Center for Food and Drug International Exchange, and Chinese Pharmaceutical Association; and officials from food and drug supervision departments of Tianjin, Inner Mongolia, Zhejiang, Hubei, Hunan, Guangdong, Gansu and other provinces or cities (regions).
Zhao Yixin, chairman of CAMDI, Fan Xiaodong, executive vice-chairman of CAMDI, Xu Shan, secretary general of CAMDI were also invited to attend the conference.
