CFDA informs the reform of drug approval system

Issued by the State Food and Drug Administration on October 13, 2014 On October 9, 2014, the State Food and Drug Administration held the "Symposium on handling key suggestions of the second session of the 12th National People's Congress" At the meeting, some representatives of the National People's Congress of the pharmaceutical industry were informed about the reform of the drug review and approval system of general concern to the industry, and again listened to the suggestions and opinions of the representatives of the National People's Congress, the general office of the Standing Committee of the National People's Congress, the National People's Congress, the general office of the State Council, and other relevant ministries and commissions Wu Zhen, deputy director of the State Food and drug administration, attended the Symposium and made a speech In 2014, the National People's Congress took the reform of drug review and approval system as one of the 18 key handling suggestions, which was handed over to the State Food and drug administration, together with the editorial office of the Central Committee, the national development and Reform Commission and the Ministry of finance In order to handle the key suggestions, the General Administration of the people's Republic of China specially held a symposium to listen to the opinions of the deputies of the National People's Congress on handling the key suggestions At the symposium, the main leaders of relevant departments and bureaus of the General Administration introduced the handling process of key suggestions, difficulties faced by the reform of drug review and approval system, efforts, key contents and work progress, etc The central editorial office, the national development and Reform Commission, the Ministry of Finance and other key suggestion handling units introduced the handling of comprehensive reform suggestions on drug review and approval system The education, science, culture and Health Committee of the National People's Congress fully affirmed the key suggestions of the general administration The representatives of the National People's Congress present at the meeting put forward constructive opinions and suggestions on food and drug supervision, especially on the reform of drug review and approval system Cai Dongchen, deputy to the National People's Congress, said, "I have served as a deputy to the Fourth National People's Congress This time, the General Administration and relevant departments are most satisfied with the handling and response of key suggestions! It is hoped that the reform of drug review and approval system will be implemented as soon as possible to solve the problem of overstock of drug review and approval " Ren Wuxian, a deputy to the National People's Congress, said, "it is suggested that the pace of reform be greater! At the same time of increasing the team of review and approval personnel, it is suggested to adjust the management of drug registration fees, try to purchase services from a third party, allocate personnel and arrange remuneration in accordance with market principles " Zhao Chao, deputy to the National People's Congress, suggested that the drug review strategy should be further improved and adjusted, priority drugs should be selected, and the approval of drugs for major diseases, rare diseases, elderly and children's diseases should be accelerated Wu Zhen pointed out that the key suggestions of the NPC representatives fully reflected the concerns of the representatives on the food and drug supervision work, and also reflected the level of participation in politics and discussion of the people's opinions These suggestions are not only a breeze, but also a driving force for the food and drug supervision work At present, the problems existing in the drug review and approval work, such as the long period of drug review and approval, the insufficient number and technical capacity of review institutions, the unreasonable division of powers, and the imperfect priority review mechanism, are not compatible with the requirements of the central government on strengthening and improving people's livelihood, the growth of public health needs, and the promotion of innovation and development of the pharmaceutical industry Wu Zhen stressed that in accordance with the overall plan of the central government to comprehensively deepen the reform, the general administration plans to improve the efficiency of review and approval by reforming key links such as drug acceptance mode, technical review management system and administrative approval management mode, as well as by strengthening technical review force, rationalizing funds and charging management mode and other reform safeguard measures The General Administration will further strengthen communication with deputies to the National People's Congress and members of the CPPCC, widely adopt relevant opinions and suggestions, jointly accelerate the reform of drug review and approval system, effectively solve the bottleneck problems restricting the review and approval work, and comprehensively improve the ability of drug safety governance and public health protection It is understood that in 2014, the General Administration of the people's Republic of China undertook 236 proposals (proposals) of the NPC deputies, including 132 sponsored and 85 co sponsored At present, all suggestions and responses have been completed within the time limit, and most of the suggestions have been actively adopted.