General Administration of food and drug: 80% of drugs to be approved for production have been killed

Source: Xinhua News Agency reported on January 15, 2016 that 9394 drug reviews were completed in 2015, an increase of 90% over the previous year, from the National Conference on food and Drug Administration and the construction of a clean and honest government held in Beijing, and initial results were achieved in solving the backlog of registration Bi Jingquan, director of the State Food and drug administration, introduced at the meeting that in order to improve the quality and efficacy of Chinese drugs, in 2015, the State Food and drug administration proposed 10 policies, including improving the approval standards of generic drugs and optimizing clinical trial applications And accelerate the R & D and marketing of new drugs with clinical value and clinical urgently needed generic drugs according to the "special review procedure" It has approved the production and marketing of new global polio inactivated vaccine with independent intellectual property rights, the world's first hand foot mouth disease prevention enterovirus 71 inactivated vaccine, completed the clinical trial application approval of recombinant Ebola vaccine independently developed in China, and the marketing review of tumor drugs such as abiolone acetate "At the same time, we are also eliminating the" hidden rules "of clinical trial data falsification, focusing on purifying the ecological environment for drug research and development, and ensuring that people can use drugs safely on the basis of affordable use." Said Bi Jingquan In July 2015, the state started the self-examination and verification of drug clinical trial data, checked the data authenticity and standardization of 1622 drug clinical trial projects to be batch produced, and dispatched 20 inspection teams in three batches to carry out on-site verification As of January 12, 2016, 1151 items had been withdrawn or failed, accounting for 80% of the total number of self-examination and verification, of which 77% were withdrawn voluntarily by enterprises, and 273 items remained to be verified Bi Jingquan pointed out that at present, the pharmaceutical industry is faced with such problems as rising production of raw materials, labor costs, research and development costs, increasing pressure on bidding and competition, shrinking profit space of enterprises, etc., some enterprises' adulteration makes counterfeiting, making and selling counterfeits, changing process without authorization, illegal trading and other problems occur from time to time, and the weak supervision team, low technical level, insufficient subjective initiative and so on are still drugs The severe challenge of quality supervision It is necessary to strengthen the construction of safety and quality standards, norms of enterprise production and operation behavior, guiding principles of drug and medical device research and development technology, rules and regulations, supervision informatization, inspection and testing system, professional inspector team, etc., with emphasis on strengthening supervision and inspection, product sampling inspection and case investigation, so as to effectively guarantee the life and health safety of the people "Strong regulation makes a strong industry." Bi Jingquan said that we need to serve the development and innovation of the industry with effective regulatory system innovation, so as to gradually realize the goal of a pharmaceutical power towards a pharmaceutical power It is reported that in 2016, the General Administration of food and Drug Administration will accelerate the evaluation of the consistency of quality and efficacy of generic drugs, promote the pharmaceutical industry to improve the gold content of high-tech products; accelerate the pilot of drug listing license holders, effectively mobilize the enthusiasm of R & D personnel and reduce the low-level repeated construction of drug production; establish a clinical efficacy oriented evaluation system to ensure We will promote the reform of medical device classification and encourage the innovation and research of medical devices.