Sun Xianze, deputy director of CFDA: it's time to speed up the consistency evaluation of generic drugs!

Source: e-medicine manager, August 20, 2016, sun Xianze, deputy director of the State Food and drug administration, pointed out: "the consistency evaluation of quality and efficacy of generic drugs in China is turning into a comprehensive evaluation stage." The consistency evaluation of generic drugs, which decides the life and death of pharmaceutical enterprises, is being pushed forward, and the progress of this work is undoubtedly the most concerned thing of the pharmaceutical industry On August 20, 2016, sun Xianze, deputy director of the State Food and drug administration, attended a meeting, during which he made a report on the theme of "drug regulatory innovation and supply side structural reform of the pharmaceutical industry" In the report, he combed the policies related to the conformity evaluation of generic drugs, and pointed out that "the conformity evaluation of quality and efficacy of generic drugs is turning into a comprehensive evaluation stage." At the same time, he stressed that it is necessary to speed up the consistency evaluation of generic drugs, promote the supply side structural reform of Chinese pharmaceutical industry, drive the transformation of pharmaceutical industry from made in China to created in China, from speed in China to quality in China, and from Chinese products to Chinese brands Prior to the gradual implementation of the incentive policy, the State Council, CFDA and the Chinese Academy of inspection have issued a series of guiding opinions or principles, involving all aspects of consistency evaluation, as well as various incentive measures Sun Xianze said at the meeting that he hoped that pharmaceutical companies would make good use of relevant incentive policies For example, CFDA has encouraged pharmaceutical enterprises to carry out evaluation work by simplifying administration and delegating power, implementing filing system for bioequivalence test, establishing green channel for evaluation of consistency evaluation data and supplementary application for drug registration Another example is that for the varieties registered and listed in foreign countries with the same production line by domestic drug manufacturers, the State Administration encourages enterprises to go back to domestic registration, and the conformity evaluation can be considered as passed after the data review and production site inspection This is a good opportunity for domestic pharmaceutical enterprises such as Huahai pharmaceutical and Haizheng pharmaceutical to go abroad Sun also stressed that for the varieties that pass the consistency evaluation, the production enterprises can apply for participating in the pilot work of the listing permit holder system and entrusted processing, and can also transfer the approval number Earlier, the State Council has printed and distributed the pilot program of drug listing license holder system, which provides policy basis for listing license holders and entrusted processing In addition, sun Xianze disclosed that the logo and logo of the drug through the consistency evaluation have been designed by the Chinese Academy of inspection and are being reported to the State Administration of industry and commerce The labels specified by the drug regulatory authorities shall be printed in the instructions and labels for the convenience of public identification and use by medical institutions At the same time, Zhang Zhijun, vice president of CFDA, who attended the forum, also disclosed that next, two documents, i.e the drug inspection agency meets the inspection requirements and the clinical effectiveness test filing procedure, are also under internal discussion Industry insiders pointed out that with the issuance of these supporting documents and the basic matching of policies related to the consistency evaluation of generic drugs, all enterprises have entered the arena of life and death and entered the countdown Since the consistency evaluation of generic drugs has been broken by each of them, enterprises have also faced many practical problems At the forum, Zhang Zhijun pointed out the difficulties faced by enterprises in the actual implementation process, such as tight time, heavy tasks, difficult selection and acquisition of reference preparations, as well as the shortage and high price of clinical trial institutions The good news is that sun Xianze and Zhang Zhijun both revealed that CFDA has recently sorted out and summarized the policy and technical problems faced by more than 30 pharmaceutical enterprises, and will make a public explanation in the near future Among them, the industry response is more intense clinical resource shortage, affecting the progress of work In response, sun Xianze said that the state is also considering or changing the certification system to the filing system Earlier, CFDA had put on record the bioequivalence test of some qualified chemicals It is revealed that CFDA is also considering streamlining administration and delegating power, and authorizing the bioequivalence test to the provincial administration However, the registration of clinical trials still needs the authorization of the National People's Congress when the drug administration law has not been changed It is understood that at present, the pharmaceutical sector has been authorized by the National People's Congress level system reform, only the listing permit holder system In addition, in order to speed up the progress of this work in pharmaceutical enterprises and help enterprises solve practical problems, CFDA has conducted seven trainings in the first half of the year According to sun Xianze, CFDA will continue to carry out relevant free training, such as acceptance and evaluation of materials, on-site inspection, clinical verification and use of reference preparations He also said that at present, the generic drug conformity evaluation office and the drug audit center are jointly promoting the work It is reported that at present, there are more than 230 people in the drug Audit Center, and the total number of temporary employees in the provincial bureau is 330 Next, a large number of talents will be recruited, striving to reach 600 by the end of the year The earlier incentive policies in payment, bidding and clinical application of medical insurance were questioned due to the cooperation of medical insurance, bidding and other departments In response, sun Xianze said that CFDA has reached an agreement with the health and Family Planning Commission, the Ministry of human resources and social security and other relevant departments to jointly promote the evaluation of generic drug consistency "As long as the conformity assessment is passed, the regulatory authorities will immediately abandon the independent procurement of imported drugs and put generic drugs and original research drugs on the same platform." In addition, in terms of project funds, the national development and Reform Commission, the Ministry of Finance and the Ministry of industry and information technology are increasing their support for policy funds, and supporting production enterprises to carry out consistency evaluation by means of industrial development funds, awards instead of subsidies, technical transformation subsidies, loan discount, etc It is reported that at present, Heilongjiang Province has provided a lot of funds to support some enterprises to carry out the consistency evaluation, and Sichuan Province has also provided separate financial support for some varieties To urge enterprises to speed up the progress of exclusive varieties, especially the recent CFDA released 289 generic drug conformity evaluation varieties, including 17740 approval numbers The introduction of the catalogue is believed to help pharmaceutical enterprises have a clearer understanding of the specific situation of the manufacturers and varieties of generic drug consistency evaluation, so that pharmaceutical enterprises can select more valuable varieties in a targeted way and maximize the benefits of resource use Sun Xianze said at the meeting that the publication of the catalog of varieties to be evaluated is actually to let all enterprises see and decide whether to do or not, so as to urge pharmaceutical enterprises to promote the progress of generic drug consistency evaluation as soon as possible "The problem of overcapacity is most incisive in 289 varieties The average productivity of all varieties is only 25.22% Many products are not produced for many years, which is actually the weakness of enterprises." Sun Xianze said It is worth noting that there are 36 varieties with 2-3 approval numbers and 23 varieties with only one approval number in the catalogue In this regard, sun Xianze reminded the relevant enterprises not to drop the chain, to speed up the evaluation progress "Next, the food and drug regulatory department will establish a quarterly table to timely report the evaluation results of the same varieties For the varieties that are slow in evaluation progress and may affect the market supply, the relevant departments should strengthen the financial and technical guidance to ensure the accessibility of clinical drugs If any enterprise does not do it, it will publish it, consider listing it in the clinical shortage catalog, and encourage other manufacturers to copy it " Sun Xianze said At the same time, he reiterated the objectives of carrying out the consistency evaluation of generic drugs: first, improving the overall level of the pharmaceutical industry to ensure the safety and effectiveness of public drug use; second, promoting the supply side reform of the pharmaceutical industry to promote the adjustment of industrial structure; third, enhancing international competitiveness and promoting domestic drugs to the world