Who can escape the hand of death of CDE successfully

At the end of March 2015, the National Conference on drug registration and management was held in Beijing This year, the State Food and Drug Administration (CFDA) will make every effort to promote the reform of drug approval system The policies involved in the adjustment include: innovative drug listing permit holder system, innovative drug special approval system, generic drug approval strategy adjustment, pharmaceutical excipients drug package related review , adjustment of drug registration acceptance mode, improvement of registration fee standard and other major systems In 2014, China's drug registration and approval showed three characteristics: the number of drug registration and acceptance continued to grow, the proportion of new drug applications significantly increased, and the total number of approved varieties significantly increased In 2014, according to official statistics, the number of drug registration applications increased from 6294 in 2010 to 8868, with a cumulative increase of 40.9% over the past five years What's the change in the number of drugs CDE recommends for approval? Who can escape from CDE's hand of death? Let's have a look 1、 According to the drug review report issued by the drug review center (CDE) of the State Food and Drug Administration and the statistics of drug intelligence registration and acceptance database, the total amount of chemical acceptance has increased year by year, and in 2014, the number of new chemical acceptance has reached 1420 Figure 1: the acceptance and approval of chemical drugs for marketing from 2010 to 2014 are not as optimistic as the acceptance of chemical drugs Since the statistical year of 2010, the number of CDE recommended approvals has decreased significantly, especially to 374 in 2013, and to 478 in 2014 The number of chemical drugs approved also reflects the approval of drug registration Figure 2: in fact, the decrease in the number of drug approvals from 2010 to 2014 does not mean the decrease in the efficiency of CDE approval, but rather represents a stricter approval system In 2014, the drug Audit Center completed the technical review of 5261 registration applications, an increase of 12.9% over the review completed in 2013, while the final drug Audit Center completed the review and recommended that the State Administration approve only 501 listed drugs, accounting for less than 10% of the review, of course, it did not include the approval of new drug clinical trials, supplementary applications and re registration applications In this case, enterprises should also carefully examine their own shortcomings and analyze the reasons It is an inevitable trend for the drug registration and approval system to be closer to internationalization In order to cope with the sudden changes, enterprises must constantly improve, enhance their R & D capabilities, and attach importance to the quality of drugs Next, let's analyze the details of chemical approval Figure 3: details of chemical drug approval in 2010-2014: new drugs are approved for marketing, that is to say, there are 103 new drugs in 2010-2012 and 128 new drugs in 2014 Before 2012, the proportion of Anda is very large In 2010, the number of approved generic drugs on the market is more than six times of the number of new drugs approved, and will be two times by 2014 From here, it is not difficult to reflect that the current trend of drug research and development in China is gradually changing, and the state's emphasis on new drug research and development is also deepening In terms of imported drugs, the "three trials and three batches" which were discussed a while ago must have a fatal impact on imported drugs 2、 Figure 4: acceptance and approval of traditional Chinese medicine from 2010 to 2014: approval for listing of traditional Chinese medicine was slightly depressed, from 81 in 2010 to 11 in 2014, with a decrease of 86.4% Figure 5 details of approval of traditional Chinese medicine from 2010 to 2014: the approval of traditional Chinese medicine focuses on the application of new drugs and dosage forms It can be seen that in 2014, only 11 new traditional Chinese medicines were proposed to be approved for marketing, and no other application types were approved In 2010, a new type of application for change of dosage form, i.e drug application with registration classification 8, encountered Waterloo in 2014, and the approved quantity was 0 The difficulties in the research and development of traditional Chinese medicine are unavoidable The lack of new drug research and development and the lack of secondary development of old varieties ultimately lead to the lack of development potential of traditional Chinese medicine industry In 2007, the State Food and Drug Administration substantially improved the standards for new drug research and development In clinical trials, according to the international general principles, placebo control is needed, so as to avoid the situation that the new drug can be approved as long as the efficacy of the new drug is not worse than that of the positive drug, and false positive can be excluded To some extent, the standards of new drug research and development have been greatly improved, resulting in the number of approved new drugs from one extreme to another In the past two years, the number of new Chinese medicine approved by the drug audit center each year is only more than 10 For example, in 2014, according to the drug intelligence registration and acceptance database, 11 drugs were approved in total, of which only 1 drug was in 5 categories and 10 drugs were in 6 categories 3、 Figure VI of biological products in recent two years, the number of biological products approved for listing has decreased, with 15 in 2013 and 12 in 2014 Figure 7 details of approval of biological products from 2010 to 2014 the number of approved biological products, including domestic imports, has declined to a large extent in the past two years According to the statistics of the drug Audit Center, 523 registration applications were completed in 2014 and submitted to the General Administration for approval, including 338 approval conclusions, 111 disapproval conclusions and the overall disapproval rate of 24.7%; 13 approval conclusions and 12 disapproval conclusions of biological products (NDA) applied for listing Of them, the disapproval rate was 48% In recent years, the field of biology is a hot area in the global drug research and development, and the traditional chemical pharmaceutical research and development has encountered a bottleneck The revolution of biotechnology has brought a new perspective and field to the research and development of new drugs In recent years, the rapid development of global biopharmaceuticals stems from the fact that biopharmaceuticals have overcome many medical problems that traditional drugs cannot solve However, the research and development of biopharmaceutical industry in China is relatively lagging behind, the lack of talents, and the lack of capital related industry knowledge, which makes this hot field a little cold, and now it is mainly concentrated in the first-line developed cities If we want the whole pharmaceutical market to be active, the biological field can not be ignored CDE really controls the life and death power of drug declaration like the God of death If we want to survive, we have to arm ourselves Note: the intellectual property rights of the above articles belong to yaozhi.com If you need to reprint, please indicate the source and the link of this article.