Pool Insights and Wisdoms to Advance Drug Administration

  • 2019-01-08
On the afternoon of January 4th, the National Medical Products Administration (NMPA) held a symposium to collect the opinions and suggestions on drug administration from deputies to the National People’s Congress (NPC), members of the national committee of CPPCC, experts and scholars, and representatives of China Association for Medical Devices Industry (CAMDI). Li Li, Party Secretary of the NMPA, took the chair; Jiao Hong, Director of NMPA, introduced the current drug administration; and leaders Xu Jinghe, Chen Shifei, and Yan Jiangying, attended the meeting.

Representative members, experts & scholars and the CAMDI leaders presented pertinent comments and suggestions on drug administration. They emphasized that the NMPA should continue the reform of review and approval system, enhance the capacity building on review and approval, and support the supply-side structural reform of drugs, medical devices, and cosmetics, with the aspiration to meet the demands of the people for safe, new and quality drugs. They also appealed for accelerating the improvement of drug administration regulations and standards system, to provide guidance for drug regulation and enterprise development.

Li Li said that 2019 marks the 70th anniversary of the founding of the People's Republic of China, and drug safety is closely related to people's lives and health. So drug administration is of great significance. The NMPA will adhere to the implementation of “Four Most Stringent” requirements, press ahead with the reform resolutely, ensure safety, increase quality and strengthen foundation, continue the innovation of regulation pattern, improve regulation system and mechanism, deepen implementation of safety responsibility, enhance supervision team construction, and make drug regulation more scientific, law-based, international and modernized, so as to safeguard the health of the people. He also called for the representative members and experts & scholars to contribute to drug regulation, publicize and introduce the drug administration, to enhance the community's understanding and support for drug regulation. And he hoped that the CAMDI can fully play the role of bridge, urge and guide enterprises to implement the responsibility of drug safety, to jointly manage the drug safety.

Jiao Hong summarized the 2018 drug administration and underlined the focus of 2019 drug administration. She concluded that the NMPA gave great impetus to the reform of drug and medical device review and approval system in 2018, approved 48 new drugs, including the 9-valent HPV vaccine, and the Treprizumab Injection. The consistency evaluation on quality and efficacy of generic drugs progressed steadily. The NMPA spared no efforts to deal with the Changchun Changsheng vaccine case, fully investigated Chinese vaccine manufacturers, and explored the establishment of a long-term vaccine management mechanism. The NMPA efforts also included strengthening the full life cycle supervision of drugs and medical devices with on-site inspection and other supervisory measures. The NMPA joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Management Committee (MC) and held the rotating chairmanship of the International Medical Device Regulators Forum (IMDRF), and organized two MC meetings. The drug administration capacity in China continues to improve, and has been recognized internationally. Jiao Hong emphasized that the 2019 drug administration will further focus on the “Four Most Stringent” requirements, with the objectives to adhere to the bottom line of drug safety and pursue the high line of high-quality development. The efforts also include the acceleration and improvement of reform of regulation and standard system; deepening of the reform of the drug and medical device review and approval system; strengthening of oversight of the full drug life cycle; promotion of scientific research on regulation and intelligent regulation; strengthening oversight and corporate responsibility; improvement of the capacity building of regulatory authorities; increase of sense of service, to blaze a trail in drug administration.

Representatives of the Legislative Affairs Commission (LAC) and the Education, Science, Culture and Health Committee of the Standing Committee of the NPC, the Committee of Education, Science, Culture, Health and Sports and the Committee for Handling Proposals of the National Committee of Chinese People's Political Consultative Conference, chief officials of the relevant departments and directly affiliated institutions of the NMPA attended the symposium.

Zhao Yixin, the deputy to the 12th NPC and president of CAMDI was invited to the meeting and discussed with the participants on the opinions and suggestions collected on “Strengthen training and establish the management system of medical device master document in China”.