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    Home > Active Ingredient News > Drugs Articles > Phoenix Nirvana or waves, drug registration refused to approve tide who will be out?

    Phoenix Nirvana or waves, drug registration refused to approve tide who will be out?

    • Last Update: 2015-12-10
    • Source: Internet
    • Author: User
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    Source: from December 7, 2015 to October 7, 2015, the State Food and Drug Administration (CFDA) issued the announcement on the disapproval of 13 registration applications of 14 enterprises (No 260, 2015) This is the second round of rejection from CFDA's announcement on self inspection and verification of drug clinical trial data (No 117, 2015) released on July 22 this year In addition to the "primary responsibility" applicants - major pharmaceutical companies affected, clinical trial organizations (cros) and hospitals participating in clinical trials will also be investigated or processed The sharp edge of China's drug registration reform has been suspended For many small and medium-sized pharmaceutical enterprises, the cold winter of the market seems to be coming What makes people think is whether this winter will be extra long? Which players can survive after the aftershock? Waves and sands: "shrimp" is out first? In my opinion, the key word of announcement 117 is "self inspection" CFDA requirements: all drug registration applicants who have applied for and are pending for approval by the General Administration of drugs shall, in accordance with the relevant requirements of the "quality management specification for drug clinical trials" and other relevant requirements, conduct self-examination on the application for drug clinical trials for registration of drugs that have applied for production or import against the clinical trial scheme, so as to ensure the authenticity and reliability of the clinical trial data and the integrity of relevant evidence This is like an opportunity for enterprises to "introspect" Therefore, on November 11, CFDA issued the announcement on disapproval of 11 drug registration applications of 8 enterprises (No 229, 2015) On November 26, 90 enterprises withdrew 164 drug registration applications without stop On December 3, CFDA received 87 drug registration withdrawal applications from 62 enterprises The withdrawal of the application is a heroic act In announcement 229, Zhejiang Huahai Pharmaceutical Co., Ltd., whose application for candesartan ester tablet was rejected, withdrew the application of 17 varieties at one time on November 26, which was questioned by the public that 38 million drug R & D expenses were "floating", during which A-share market performance was even more green However, for the "big" pharmaceutical enterprises with sufficient funds and ammunition and various R & D imitations, it is better to "put some blood" in self inspection than to be caught after on-site inspection So they are also more active in strategic retreat And those who only rely on one or two drugs to survive and have no wrists to break are not so lucky As winter approaches, pharmaceutical companies that do not have good grain storage (do a good job in fund and talent reserve) and physical training (standardize drug research and development imitation) will retreat, which is the "road to self destruction" Many of them can only wait for the "final trial" with fluke mentality To some small pharmaceutical enterprises, to make matters worse, the "drug listing license holder system" and the "consistency evaluation of quality and efficacy of generic drugs" are coming Breaking and then establishing: from "imitating standard" to "imitating variety", on November 4 this year, CFDA's relevant director announced that MAH system is planned to be piloted in 10 provinces and cities within three years In China, in the past, only drug manufacturers could apply for drug registration and obtain drug approval number The implementation of MAH allows R & D institutions and researchers to participate in drug registration applications This "decentralization system" will greatly encourage drug R & D innovation, mobilize the enthusiasm of cros and hospitals, and help them to focus on anti customers CFDA's announcement on November 18 (Draft for comments) on the consistency evaluation of quality and efficacy of generic drugs (2015 No 231) has made a great effort in the quality supervision of generic drugs According to a person who has been engaged in research and development of generic drugs for many years, restricted by the funding and technical level, research and development of generic drugs in China in the past only needs to meet the national standards It means that the medicine can be taken, but is it effective? It is difficult to say Compared with the generic drugs, the "generic standard" drugs have certain instability and individual differences Some R & D institutions that can't go through the barriers when copying will "muddle through" according to the requirements of Pharmacopoeia, the most relaxed standard The new measures for the administration of drug registration stipulates that generic drugs should have the same active ingredients, routes of administration, dosage forms, specifications and therapeutic effects as generic drugs This is the "imitation of varieties", not only "like", but also "good" The key is coming The above-mentioned Announcement No 231 clearly points out that: for the chemical generic oral solid preparations approved before October 1, 2007 in the National Essential Drug Catalogue (2012 version), the consistency evaluation shall be completed by the end of 2018 If the evaluation is not passed at that time, the approval number of the injection and marketing drugs For other generic drugs approved for marketing before 2007 and those approved for marketing after 2007, if the same product of other manufacturing enterprises fails to pass the evaluation within 3 years after the first product passes the consistency evaluation, the approval number of the drug shall be cancelled Clinical trial non-compliance? Application not approved! Approved application, conformity evaluation failed? Cancellation of approval! Since then, it is the era of new drug registration with great momentum The real spring breeds vitality In the near and far, in the short term, the number of drug registration applications is reduced, the circulation drug catalog is "slimming", and the price war of drug companies is cooling down Is it possible to lead to the rise of drug prices, the decrease of drug selection, and the decline of a large number of small and medium-sized drug companies? In my opinion, in the past, the "irrational prosperity" of drug registration, even if a hundred flowers bloom, is also“ Wrong spring "(abnormal climate in winter, warm weather, as if spring is coming) Low threshold, loose examination and approval, low-end generic drugs are firmly established in the same competition, even if the price is low and there are many choices, but the curative effect is not good, what's the benefit for the common people? In the long run, it's really a hundred years' plan to purify the market, raise the threshold, enhance the strength of the whole industry chain, and protect the public health Winter is very cold, but it gives birth to vitality for the real spring After the shock, we will go further However, compared with cros and hospitals that "got a slap and a date", pharmaceutical enterprises may face more severe challenges If small and medium-sized pharmaceutical enterprises do not immediately rectify the transformation or hold the capital thigh, they will really "leave a vast land of white and clean".
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