CFDA answers the most concerned question in the consistency evaluation: how to solve the problem of insufficient number of institutions?

Source: e drug manager on May 17, 2016, at the 2016 China International Drug Information Conference and the eighth dia China annual meeting, Li Maozhong, deputy director of CFDA pharmaceutical registration department, discussed one of the most concerned issues in the current generic drug consistency evaluation: "the number of clinical institutions willing to undertake the consistency evaluation is limited, and the first batch of varieties are in 2018 Answer: "the deadline of the first batch of conformity assessment announced by CFDA will not be changed We will know about the acceptance of be test by the organization in the actual work Meanwhile, CFDA will work with the health and Family Planning Commission to actively promote problem solving." Is clinical resources sufficient? Insight data shows that the first batch of conformity assessment needs to be completed by the end of 2018, involving 292 essential drug catalog varieties, involving 19715 approval numbers, of which 70.34% can be identified as valid approval documents; involving 2028 enterprises, including 7 enterprises with more than 100 approval documents, 47 enterprises with 50-100 approval documents, and 529 approval documents The number of approval documents of enterprises is between 10-50; Shanghai pharmaceutical, China Resources Shuanghe, Baiyunshan, Harbin Pharmaceutical and Fosun Pharmaceutical are listed in the top five with 505, 211, 200, 144 and 132 approval documents respectively At present, CFDA still has several specific requirements and guidelines for the consistency evaluation of generic drugs in the stage of soliciting opinions With the release of official documents, the time left for the actual operation of enterprises is becoming shorter and shorter However, the general office of the State Council stressed in the opinions on the evaluation of the quality and efficacy of generic drugs released on March 5, 2016 that those not completed within the time limit shall not be registered again By the end of 2015, there were 433 GCP certificates not expired in China According to the data of CDE clinical trial registration platform and China clinical trial registration center, only 122 had carried out phase be / I projects In the checklist issued by CFDA in September 2015, 82 institutions were involved in "722 self-examination storm" Before that, in January 2016, a survey in the industry showed that only 53 of the more than 400 clinical trial institutions expressed their willingness to undertake the be / I phase project Do a simple calculation The data forecast is based on incomplete industry data and experience If you have any objection, please leave a message: be exemption is not considered temporarily If the average time for a clinical trial conducted by a clinical trial institution with 24 beds is one month; if all the work requirements of CFDA on the conformity evaluation of generic drugs can be released before June this year, then there is still 30 months to the end of 2018; if the above 53 institutions are willing to undertake be / I phase, there are 24 on average Bed in be / I phase; it is deduced that only 30 * 53 = 1590 varieties can pass this round of generic drug consistency evaluation, and each variety has 5.4 approvals on average to obtain be resources This means that nearly 90% of the more than 13800 approval documents will not have clinical resources available within the specified time limit For enterprises, no matter what the previous sales of products, who can seize the be resources will become one of the luckiest 5.4 products that dominate the market after 2019 This may also be the reason why the clinical trial cost of be, which has been frequently disclosed recently, is as high as 3-5 million yuan However, for pharmaceutical companies, this not only increases the existing cost of essential drugs characterized by "low price", but also may cause more shortages of essential drugs in the future In addition, CFDA has always stressed that "enterprises shall bear the main responsibility" since the self inspection and verification of clinical trial quality The concept will also face challenges: in the face of a monster with legal rights to harm, how can enterprises perform the function of supervision? "We should strive to create a social environment in which" good medicine can be found all over the world, but bad medicine can't be found in every step " This is the belief delivered by CFDA director Bi Jingquan in his speech at Peking University at the beginning of his term This means giving a good medicine a chance, rather than letting it peel before it can prove itself How to break such a situation? It should be noted that the above argument is a dilemma that only 53 institutions are willing to undertake be test If 122 institutions that have ever been involved in the clinical trials of be / I phase participate in the trials, the clinical resources will be relatively abundant; if all institutions with GCP certificates are forced to undertake the be trials, the above-mentioned ten thousand valid approvals will not be in short supply However, many clinical trial institutions are unwilling to undertake phase be / I clinical trials The reasons include, but are not limited to, that such trials can not help their clinical research institutions establish reputation and help relevant researchers establish academic status Therefore, to solve the priority dilemma of clinical trial resources, it is not only necessary for CFDA to find out the situation as soon as possible, reexamine GCP certification, but also for health and Family Planning Commission to coordinate the actual resources According to the reporter, since December 2015, the State Council agreed to establish an inter ministerial joint meeting system for drug and medical device review and approval system reform The inter ministerial joint meeting led by CFDA and participated by the health and Family Planning Commission has been successfully held Up to now, the topic of clinical trial resource allocation has not entered the discussion scope of the inter ministerial joint meeting.