Latest interpretation! CFDA disclosure of details of drug trial reform: expanding the scope of fraud publicity

Source: e-medicine Facebook September 18, 2015, China ASEAN drug cooperation and Development Summit Forum 2015 was held in Nanning Wu Zhen, deputy director of CFDA, Wang Lifeng, director of pharmaceutical registration department, Xu Jiaqi, director of drug review center, Ding Jianhua, director of drug audit and inspection center, Li Bo, deputy party secretary of China Academy of inspection and other CFDA officials released a number of information about "accelerating the reform of drug review and approval" before this, we made the latest interpretation at the first time Wu Zhen said that the conference invited more than 200 representatives from more than 100 enterprises to let enterprises know the ideas, practices and methods of the general administration to the greatest extent As the first person responsible for drug quality, the enterprise is the source of power to bring high-quality drugs to patients and the hope to develop advanced treatment means Wang Lifeng introduced that in order to implement the latest reform opinions on drug review and approval, the first draft of 22 relevant measures has been formed within CFDA In order to ensure that the reform can be carried out effectively, the safeguard measures of "law revision", "charging", "manpower" and "Joint Ministerial Meeting" have been launched Wang Lifeng introduced that the drug administration law is currently listed as the second-class plan of the State Council to amend the law, and the first draft should be formed during the term of office of the current government; the measures for the administration of drug registration is also being revised All reforms should be carried out on the basis of laws and reasons In addition, in order to coordinate and promote the issues and contradictions involved in the reform, the State Council proposed to establish an "inter ministerial joint meeting system" in the reform opinions, with its office located in CFDA In terms of transparency construction of review and approval, Wang Lifeng disclosed that the comprehensive disclosure scope includes "standards and technical requirements for review and approval of medical devices" and "information on application acceptance and approval of registration of medical devices", Specifically, it includes the list of approved items and legal basis, approval requirements and processing time limit, drug approval progress and results, technical review reports such as review, inspection and other technical review reports shall be published for the listed licensed products to accept social supervision; The contents of the construction of the quality control system for review include: making good quality management standards for review in accordance with the international general rules, establishing a professional technical review project team; defining the rights and responsibilities of the main reviewer and review voucher, improving the collective review mechanism, strengthening the responsibility and time limit management; establishing a review expert committee to review the disputed review conclusions, so as to ensure the scientific and fair review results; Strengthen the research on common difficult problems in the process of technical review, timely transform the research results into technical standards to guide the review work, improve the level of review standardization, and reduce the review discretion Due to the insufficient number and ability of reviewers, five measures should be taken to strengthen the construction of review team: hiring relevant experts to participate in relevant technical review according to the needs of review; establishing the post system of chief expert, scientifically setting up the post system reflecting the characteristics of technical review and inspection; promoting the construction of professional team of drug and medical device inspectors; improving performance appraisal The income gap should be appropriately widened to ensure that the technical review and inspectors can be introduced and retained; the qualified review institutions, universities and scientific research institutions should be entrusted to participate in the technical review of generic drug technology review, clinical trial review, drug safety evaluation and other technical reviews through government procurement services In addition, several new measures related to the reform are also under consideration by CFDA, some of which may be launched soon: 1 Expand the scope of drug marketing licensors Previously, the MAH system was limited to the classification of innovative drugs In the future, it may include products that pass the quality consistency evaluation, and consider including specific free trade zones (including the integration of Beijing, Tianjin and Hebei) into the scope of the listing Licensor system 2 Add pre-trial system In view of the lack of close integration between drug acceptance and review departments in the past, the review department will send experts to participate in the acceptance stage in the future, and the General Administration will inform the applicant once and for all to supplement relevant contents In view of the current situation that generic drugs are queued up in advance, only one chance is given to receive products 3 Expand the scope of data fraud publicity In response to the falsification of research data, CFDA is considering to expand the scope of disclosure of relevant responsible persons, which may include the clinical institutions involved and relevant personnel involved in the research in the future 4 The latest progress of the generic be filing system: CFDA will establish a filing network, and will publish the application conditions and technical requirements of the generic be test in a few days, and those meeting the requirements can be carried out by themselves Of course, the General Administration and provincial bureaus will increase supervision and inspection, and call for a halt at any time 5 Requirements for cancellation of approval number: according to statistics, at present, there are 167000 approval numbers in China, of which 63% are chemical drugs, 36% are traditional Chinese medicine, and 1% are biological drugs; 4200 are import approval numbers, of which 87% are chemical drugs, 2% are traditional Chinese medicine, and 449 are biological products If the approval number (import product registration certificate, medical product registration certificate) is not listed within the validity period, and cannot fulfill the responsibility of continuous inspection on drug quality, efficacy and adverse reactions, it shall not be re registered, and shall be cancelled after the expiration of the approval number.