Opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices as well as the transcript of deputy director Wu Zhen of CFDA answering questions from reporters

Source: Information Office of the State Council on August 18, 2015 held a press conference at 10:00 a.m on Tuesday, August 18, 2015 in the press release Office of the Information Office of the State Council Wu Zhen, deputy director of the State Food and drug administration, was invited to introduce the reform of the review and approval system for pharmaceutical and medical devices and answer questions from reporters The live broadcast of Chinanet is as follows: host Hu kaihong: Good morning, ladies and gentlemen Welcome to today's press conference The State Council's opinions on the reform of the review and approval system for pharmaceutical and medical devices has been officially printed and distributed Today, we invited Mr Wu Zhen, deputy director of the State Food and drug administration, to introduce the reform of the review and approval system of medical devices and answer your questions Today's press conference is also attended by Mr Wang Lifeng, director of the pharmaceutical registration department of the State Food and drug administration, and Mr Wang Chuxiong, director of the device registration department Now, please brief us 2015-08-18 09:54:47 Wu Zhen: Good morning, media friends Today, the State Council issued the opinions on the review and approval system of medical devices, which was issued on August 13 All friends have received the official manuscripts today Next, I would like to briefly introduce the drafting background and relevant contents of this opinion 2015-08-18 09:57:07 Wu Zhen: first, on the drafting background, why draft such a reform opinion In recent years, the development of pharmaceutical industry in our country is relatively fast, the quality and standard of pharmaceutical medical devices are constantly improving, and the public demand for drugs has been better met But at the same time, the problems in the process of drug and medical device evaluation are becoming more and more prominent, mainly due to the serious backlog of drug evaluation, the relatively long evaluation time of some innovative drugs, and the gap between some generic drugs and the international advanced level There are complicated reasons for these problems, both historical and institutional As we all know, China has experienced the era of drug shortage, and the start of modern pharmaceutical industry is relatively late, and the standard is relatively low Over the years, the state has taken measures to centralize the drugs under local review to the national level for unified approval The drug standards have been upgraded from local standards to national standards and GMP has been improved The level of certification, promoting the consistency evaluation of generic drugs and original research drugs and other measures have significantly improved the quality of drugs, but the overall drug standard is not high enough, the management mode is relatively backward, the review and approval system is not smooth, the mechanism is not reasonable and so on The low-level repeated application of enterprises and the untrue, incomplete and nonstandard clinical data of some registration applications have become increasingly prominent The number of approvals is insufficient and the treatment is low, which is no longer matched with the number of applications reviewed 2015-08-18 09:57:48 Wu Zhen: the CPC Central Committee and the State Council attach great importance to the reform of drug and medical device review and approval system The core of the State Council's opinions on the reform of the review and approval system of pharmaceutical and medical devices is to improve the quality of drugs, promote the structural adjustment, transformation and upgrading of the pharmaceutical industry through reform, and achieve the effectiveness, safety and quality controllability of listed products, so as to reach the advanced international level and meet the drug demand of the public This is the drafting of such a reform plan Background 2015-08-18 10:01:18 Wu Zhen: main contents of the reform opinions, including the main objectives, main tasks and safeguard measures of the reform, including three aspects, 21 reform measures in total In terms of reform objectives, we focus on five aspects: first, improving the quality of drug approval; second, solving the backlog of drug review; third, improving the level of generic drugs; fourth, encouraging innovation; fifth, improving the transparency of review and approval We have documents in hand I will not introduce them one by one The main tasks of the reform are 12, including improving drug standards, promoting the one-time evaluation of generic drugs, accelerating the review and approval of innovative drugs, and carrying out the reform of the holding system of listed licensors, etc In order to achieve the above reform, the State Food and Drug Administration will speed up the revision of the regulations on the implementation of the drug administration law and the measures for the administration of drug registration, recruit the corresponding technical personnel for drug approval for the society, strengthen the construction of evaluation team, and promote the construction of professional inspectors The opinions will play a positive role in improving the system and mechanism of drug and medical device examination and approval, improving the quality and efficiency of drug examination and approval, improving the quality of listed drugs, and promoting the innovation, transformation and upgrading of the pharmaceutical industry I'd like to give you a brief introduction of these situations Now I'd like to answer your questions 2015-08-18 10:02:15 host Hu kaihong: Thank you for the introduction of director Wu Now let's start to ask questions Before asking questions, please inform the news organizations you represent 2015-08-18 10:03:25 reporter of China Radio International: I can see from the materials that the backlog of drug registration declaration in China is quite serious Is there any specific data to say how much in recent years? What is the cause of the serious backlog problem? How to solve it? In terms of materials, the goal is to digest and complete the overstock of registration by the end of 2016 If such a serious overstock is to be digested and completed by the end of next year, it is sure to speed up the approval process Will it affect the quality of drugs? 2015-08-18 10:03:38 Wu Zhen: how much is the current drug backlog? The total number of drugs under review by the national drug review center is 21000 Compared with the current specific review capacity, to be honest, the task is still large There is a big gap between our capacity and the actual review capacity People are concerned Why 2100? The historical background and related reasons give you an interpretation The backlog of drug evaluation is a very complex process, which has historical reasons, practical problems, institutional factors and organic conditions, which are interlaced Wu Zhen: first of all, the backlog of drug registration and review is caused by history As you know, drug reviews were undertaken by provinces before 2000, so the amount of reviews was scattered in each province Since 2000, the way of evaluation has been changed and all of them have been concentrated in the central government Because the central authority of drug examination and approval matters should be unified throughout the country, which is a great reform and a good progress Therefore, when all the review powers scattered in each province are received from the central government, the review volume will naturally increase, but the corresponding personnel strength will not keep up with it, so the drug backlog problem will always exist after the receipt There have been several peaks in the history of review backlog For example, in 2005, we had a backlog of 17000 pieces At that time, only 100 reviewers took some administrative measures to cut the peak But the second peak came in 2007 and 2008, when 27000 pieces were overstocked Therefore, in 2008, centralized review was adopted to solve the backlog problem of review, but you can see that since 2011, especially in the past two years, there has been a new backlog Now there are 21000 pieces in hand, which is called three peaks and three waves 2015-08-18 10:05:06 Wu Zhen: Although we have taken some effective measures to solve the problem of peak cutting, we have not fundamentally solved the problem Therefore, the backlog problem itself is formed in history, which has many deep-seated reasons For example, the development of enterprises is very fast, but the industrial foundation is relatively weak, and low-level duplication is relatively serious Our country is still a country dominated by generic drugs Now we have 21000 varieties under review, 90% of which are chemical generic drugs, the vast majority of which are more than 80% Nowadays, the level of generic drugs is not high and the standard is not set high According to the current law, generic drugs are based on the existing national standards, which makes people think that the threshold is low Once the threshold is low, the amount of application is large In the process of large amount of application, the repetition rate is particularly serious 2015-08-18 10:07:06 Wu Zhen: we have a data, there are eight varieties, more than 100 enterprises are applying, there are 23 varieties, there are 50 to 99 applying There are 20-49 repeat declaration enterprises of 89 varieties There should be more than 100 varieties of such three numbers, involving nearly 3000 applications You can see how high the application backlog is Because of the repetition, many product approvals are idle in the market At present, the number of approval documents owned by the national drug manufacturing enterprises is 168000, but there are only more than 50000 approvals for the products that are actually sold on the market, in other words, 2 / 3 of them are sleeping This is a phenomenon On the one hand, surplus products are not produced, and on the other hand, enterprises continue to declare In fact, this kind of duplication takes up our very limited review resources, and the approved products do not have much market value Wu Zhen: another reason is that the quality of enterprise declaration is not very high now, because everyone wants to be fast, so the data declaration has not been completed and is not completely reported In the data we accept, the incompleteness and irregularity are common, and even the data may be untrue What is unreal? Untruth is fraud It is noted that a notice has recently been issued on the verification of clinical experiment data, which aims to crack down on and detect the fraud in clinical experiments Untrue and incomplete, that is to say, this data cannot prove the effectiveness and safety of this drug Can such drugs be approved? Dare not approve There are also some irregularities, and the reported information is not available for review If it is not standardized and complete, such data will be supplemented repeatedly After the completion of distribution and supplementation, the enterprise will supplement the data, and then it will have to queue up again when it comes back We will have to review again and again This is also the reason why the review time is longer 2015-08-18 10:09:45 Wu Zhen: of course, from our own point of view, there are also reasons We have too few reviewers We just talked about 21000, which is all we have But every year, the number of enterprises nationwide, like the drug registration documents we applied for, is 8000-10000, but our reviewers are only 120 120 people asked to complete more than 8000 reviews a year Let's think about the task Therefore, the contradiction between the shortage of personnel and the review task is very prominent, and the contrast is very large We can complete 4000-5000 drug reviews every year, with an average of 40-50 for each person You may not have any idea about this number I can use a relevant data as a comparison to see whether it is large or small As we all know, the U.S FDA has a high evaluation standard and a strong force It is also widely recognized that only 5000 people review chemicals and undertake the evaluation of 3000 varieties every year In contrast, the review workload and the speed of completion are huge in our country 2015-08-18 10:11:31 Wu Zhen: at the same time, not only are there few reviewers, but also the review treatment is very low everybody