The second anniversary of the July 22 Massacre

Since July 22, 2015, the State Food and Drug Administration (hereinafter referred to as CFDA) has entered into the new policy mode / emergency mode The new policy of medicine is emerging in an endless stream The first policy has not been understood or even finished yet The second policy has come out again, and it is often issued before holidays such as weekends, so that the relevant personnel of the enterprise can only study the policy in a good time It's just two years since the new medical policy came into being I'm willing to sort it out for readers Since May 2015, CFDA has greatly increased the drug registration fee standard, tried to use economic leverage to reduce the number of drug applications, which has sounded the clarion call of this round of new drug policy reform, but for the pharmaceutical enterprises with a large fortune, the impact is not too great, so in July 2015, CFDA issued the announcement of carrying out self inspection and verification of clinical trial data of drugs, which triggered the "7.22" tragedy in the pharmaceutical industry (most of them Clinical trials failed to pass the verification), which also officially announced the start of the new medical policy The new medical policy started in a cruel way, which brought great pain to the industry When some small and medium-sized enterprises without R & D strength are still secretly glad that they have not done clinical trials, "7.22" tragedy has nothing to do with themselves, the second wave of new policy hit out heavily In February 2016, the release of "opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs" started Starting gun for consistency evaluation Originally, 289 varieties were involved, and the total number of approval documents was 17740 However, from the perspective of the market, the enterprise actively participated in 289 varieties, which led to the comprehensive spread of the consistency evaluation of oral solid preparation generic drugs According to the statistics of pharmaceutical intelligence data, in this round of competition, the state-owned enterprise is Lei Shengda (the number of state-owned enterprises such as Baiyunshan Pharmaceutical Group Participating in the filing of preparation varieties) Many), the private enterprise is fast (at present, the private enterprises such as Zhengda Tianqing and xinlitai have completed pharmacy, and those who have prepared or started be are mainly private enterprises), which also conforms to the slow action of state-owned enterprises Of course, there is something pleasant about the new deal, that is, CFDA has implemented relevant policies and measures to speed up the backlog of drug registration applications, which has moved some senior researchers to tears: "ah, it is finally expected to see the drugs developed by itself on the market before retirement." Let people in the legal field also rejoice: "ah, CFDA and CDE can finally complete the review on time according to the review time limit required by laws and regulations, and we are a step further away from the rule of law China." At the same time, in order to solve the contradiction of overstocked drug registration applications, make full use of review resources, and accelerate the R & D and marketing of new drugs with clinical value and generics urgently needed in clinic, CFDA issued the priority review and approval system in February 2016, which greatly strengthened the Matthew effect in the field of drug application: the more market needs, the more good varieties with large market can be listed quickly, and the more economic Benefits The combination of the two policies makes the approval speed of good products change from pulling a car by an old ox to flying, don't you believe? Directly above the data As can be seen from the above figure, it took nearly 60 months for a variety declared in 2012 (also catching the last bus of priority review) to complete review and approval, while in 2016, the new varieties declared basically completed review within 10 months In addition, there are reform of chemical drug registration classification, be filing system, recognition of foreign clinical trial data, synchronous development of international clinical trials of new drugs and other policies have been implemented, patent linkage system and data protection system have been put on the agenda, and new drug registration management measures are seeking opinions Do you feel a little disordered? Don't worry In short, the idea of CFDA's new drug R & D policy is mainly to integrate with the internationalization, encourage innovation and reduce low-level repetitive research Some people joked that CFDA is going to become FDA I said that this is very good The pharmaceutical industry is the most affected by the policy It is the scientific FDA that has created a strong American pharmaceutical industry Recently, China has also joined the ICH (medical WTO) Only in a sound and scientific policy environment, can Chinese pharmaceutical enterprises grow and go global The implementation of the new policy will change China's long-standing disadvantages: on the one hand, it will take 5-8 years for international innovative drugs to be listed in China, making patients watch (foreign) drugs can't be used, or even pay the cost of life; on the other hand, even if the patent of the original research drug expires for a long time, because the domestic clinical trial data of generic drugs are not reliable, the quality is not qualified, and it can't replace the original research drug, medical The cost of medicine remains high Under the new policy, international new drugs can be put on the market at the same time, but once the patent expires, there are good generic drugs to replace the original research drug market It not only ensures the accessibility of drugs, but also controls the cost It not only encourages innovation, but also gives generics a space In addition, there is another mission of the new policy, which is to improve the industrial concentration, raise the threshold, so that too many enterprises and too many approvals will disappear in the new policy, while the two vote system is to make too many small pharmaceutical companies in the circulation industry disappear Although this is the market territory, the relevant departments do not deny that it seems cruel, but it is also an inevitable way Maybe this is why our policies are always too hasty and ruthless in the eyes of some pharmaceutical companies Therefore, when we see the dawn after the pain, it refers to the whole pharmaceutical industry, and refers to the enterprises with innovation awareness, research and development ability, and entering the innovation track However, those enterprises who cling to the old varieties and live by the old varieties will still see a sunset As a result of the continuous implementation of the new policy, it also dispelled the worries about "the resurgence of sports inspection" when the "7.22 Massacre" occurred in the pharmaceutical industry This is also considered in the tragic "sacrifice" of the species to die, it is a sacrifice! Related articles recommended by the author: Declaration of 10-year memorial of 2006 drug registration and verification tragedy: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!