The withdrawal of drug registration application like a fuse brings new drug research and development back on track

Source: on January 13, 2016, if we summarize 2015, what is the most shocking thing for the pharmaceutical industry? It should not be the most noisy drug bidding, after all, the implementation of policies to various places is still unknown The most shocking thing about this industry is the Announcement No 117 of the State Food and drug administration Before the end of 2015, the total number of drug registration applications withdrawn by the applicants was 727 Announcement No 117 clearly states that "all drug registration applicants who have applied and are awaiting examination by the General Administration shall carry out self-examination on the clinical trials of the drugs applied for registration of the drugs that have applied for production or import, so as to ensure the authenticity and reliability of the clinical trial data and the integrity of the relevant evidence If the applicant finds that the clinical trial data are untrue and incomplete through self inspection, he can apply to the State Food and Drug Administration for withdrawal of registration before August 25, 2015 " The 727 withdrawals did not happen overnight, but one after another Whether they were foreign enterprises, state-owned enterprises, generic drugs, new drugs or even major special drugs, they were doomed In addition to the confusion behind the clinical application of Chinese drugs, more people can realize why 10000 new drugs can be approved in one year If in other countries, even if the drug regulatory authorities dare to approve 10000 new drugs, no enterprise can submit 10000 new drug application materials It seems that since many years ago, the public secret of the industry is that many drugs have been on the market, and even no clinical research has been carried out, but a similar material has been produced Where did ultra-low quality R & d come from? A series of self-examination and verification by CFDA made many pharmaceutical enterprises set off a "withdrawal trend" As of December 31, 2015, hundreds of enterprises have withdrawn drug registration applications in 2015 In addition, some drug companies' drug registration applications have not been approved by the General Administration, for the same reason that the clinical trial data are not true and perfect For these companies, the only way to do that is to give up registration or to reorganize clinical trials For the withdrawn enterprises, the way out given by SFDA is: "for the registration application withdrawn voluntarily, the applicant can reorganize the clinical trial according to the new requirements." Although this may allow a large number of previously withdrawn pharmaceutical companies to have a "way out" However, most of the enterprises that choose to withdraw are in the same attitude The determination of the general administration to regulate the clinical trials of drugs is very strong Pharmaceutical enterprises need more expensive research costs to supplement and improve the relevant clinical trial procedures, and still face the risk of failure Many pharmaceutical companies do not intend to carry out the clinical trials again for the time being For some large local pharmaceutical companies, the withdrawal and disapproval rate of drugs invested more than 10 million yuan is also very high For a long time, the R & D of new drugs in China is almost zero For pharmaceutical companies, the best way to make profits is to try to take the lead in copying and selling excellent imported drugs After the patent expires, the speed of listing becomes the key Although the patent of patented drugs expired, but the production technology is still confidential, the enterprises lack of R & D strength can only rely on counterfeiting to solve the problem, and the low standard of generic drugs makes this counterfeiting phenomenon increasingly rampant The inspection also involves a large number of cro companies, and the large-scale low-cost competition of cro companies makes R & D outsourcing almost become a farce Low quality R & D has always been a problem in China If we can't overcome the difficulties patiently, the quality of domestic drugs will not go up, and it's impossible to achieve real R & D innovation Thirty years ago, a number of pharmaceutical companies in the United States made a lot of data fraud in order to apply for generic drugs first It was not until the FDA launched a severe rectification that the chaos in the generic drug market was changed To what extent CFDA can persist in this rectification will directly determine whether the quality of China's R & D can be improved According to the information released by the General Administration, this self-examination and verification involves 1622 pending drug registration applications, including 948 new drugs, 503 generic drugs and 171 imported drugs Obviously, this verification is not aimed at generic drugs Some good people are also actively collecting withdrawn information Some of the withdrawn new drugs have been included in the national "12th Five Year Plan" major new drug creation projects In this way, the new drug with amulet has also been withdrawn, and the determination of the food and drug administration to rectify the disorder of clinical research can also be seen China's drug approval personnel are limited, and the approval ability is relatively weak From a positive perspective, the more varieties are withdrawn, the more drug efficiency will be improved The existence of a large number of "garbage" drug registration applications actually disperses the efficiency of drug approval and the number of drug approval For a long time, our country has been adopting the sports centralized review to solve the problem, but if the quality of declaration can not be improved, then the examination and approval is delayed, and the phenomenon of declaration backlog can not be solved at all China's drug declaration volume has always been very high Compared with Europe, the United States and Japan, it is a geometric scale, but the actual R & D capacity is much worse than that of the pharmaceutical powers Only when these low-quality applications are less, can real new drug applications get faster approval.