Life and death of generic drugs: drugs failing to complete conformity assessment within the period will be cancelled

The R & D investment of Chinese pharmaceutical manufacturers is insufficient, the innovation ability is not strong, and the quality of some generic drugs is far behind the international advanced level China has sounded the clarion call of drug self-help war and launched comprehensive generic conformity assessment to narrow the gap Opinions on the evaluation of quality and efficacy consistency of generic drugs (hereinafter referred to as "opinions") issued by the general office of the State Council was officially released in March, requiring pharmaceutical enterprises to evaluate the consistency of quality and efficacy between generic drugs and original research drugs, and the whole pharmaceutical industry is about to undergo a reshuffle "More than half a year later, many enterprises have not started this work." An expert in the pharmaceutical industry said Distance between generic drugs and original drugs FDA (food and Drug Administration) documents pointed out that generic drugs that can be approved by FDA must meet the following conditions: they contain the same active ingredients as the imitated products, and the non active ingredients can be different; they are consistent with the indications, dosage forms, specifications and drug delivery routes of the imitated products; they are bioequivalent; their quality meets the same requirements; the GMP standards of production and the Imitation products are equally strict "Only one tablet is needed for the original research drug, but five tablets are taken in China If we want to reverse this situation and improve the efficacy of Chinese generic drugs, we can only pass the drug consistency evaluation, which is a common method in the world and a necessary way In history, the government has opened the door to generic drugs Without conducting drug consistency evaluation experiments, the government has embarked on the road So far, this problem can no longer be avoided The quality and efficacy of Chinese drugs must be further improved " An expert involved in the drafting of the 12th Five Year Plan for national drug safety said In the absence of medicine and pharmaceutical industry, the emergence of generic drugs has saved many people's lives At present, China has 187000 drug approval numbers, of which 168000 were approved before 2007 Among the 7000 and 121000 approved chemicals, the vast majority are generic drugs "Compared with the original drugs, generic drugs are cheap and popular with consumers However, China's drug approval only carries out "quality standard" control, without bioequivalence verification That is to say, most of the generic drugs are only of the same chemical composition, and whether the clinical effectiveness is the same cannot be guaranteed, resulting in a large number of "qualified invalid drugs" occupying the main body of generic drugs In the world, generic drugs produced in our country are basically not recognized " A pharmaceutical industry expert said Fan Bi, inspector of the comprehensive Department of the Research Office of the State Council, mentioned in his research report on the reform of China's drug regulatory system that a large number of generic drugs, Chinese patent drugs and even fake and inferior drugs with quality and safety risks enter the formal channels through improper means such as local protection, commercial bribery, false advertising, including the national essential drugs directory and the medical insurance reimbursement directory In order to win the bid, the price of some products is reduced to below the cost, and the quality of drugs is not guaranteed However, it is difficult to promote the application of drugs with exact curative effect and strict scientific verification if they are not suitable for the "potential rules" of the pharmaceutical industry Therefore, the phenomenon of "expelling the good medicine from the bad medicine" appears, which wastes a lot of medical expenses At present, China's drugs with only quality assurance and no efficacy assurance have become a gap between generic drugs and original drugs The Chinese imitators who have not passed the pharmacodynamic evaluation of the supplementary course of history must go through the life and death relationship of drug consistency evaluation According to the opinion, for generic drugs approved for marketing before the implementation of new registration and classification of chemical drugs, if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original drugs, the consistency evaluation shall be carried out For the chemical generic oral solid preparations approved for marketing before October 1, 2007 in the national essential drugs catalogue (2012 Edition), the conformity evaluation shall be completed by the end of 2018, in which the clinical effectiveness test and the varieties with special circumstances shall be completed before the end of 2021; those not completed within the time limit shall not be registered again An official from the State Food and Drug Administration said: "it's a lesson in history to evaluate the consistency of generic drugs that have been approved for listing The United States, Japan and other countries have gone through the same process " "The Chinese government has given drugs the lowest entry threshold After many years of operating drugs, every enterprise should consider to do drug consistency evaluation and assume the responsibility of the enterprise More than 90% of them are big generic countries without consistency evaluation Why not do this work? In the early stage, you also made money Now you can't afford to do experiments Can you say that? " An expert involved in the development of the generic drug conformity assessment document said According to preliminary statistics, there are 289 varieties, 17740 approval numbers or registration numbers in the list of basic drugs for the chemical generic oral solid preparations approved for marketing before October 2007, involving 1817 domestic production enterprises and 42 imported drug enterprises "Consistency evaluation is both a challenge and an opportunity for enterprises Consistency evaluation is a matter of life and death for enterprises and a process of survival of the fittest The number of documents is meaningless, and only the varieties with the same quality and efficacy as the original drugs can have market value " The official said After the "opinions" was issued, Chinese pharmaceutical companies were all sobbing Do or not, choose to live or die? "Some old chemicals can't find the reference reagent now, some can't confirm, some can't buy the reference reagent In addition, there is a lack of scientific research capacity and talents for consistency evaluation In addition, time is pressing and clinical institutions are congested More than half a year later, many enterprises have not started this work " A pharmaceutical industry expert described the gluing state of the war so many enterprises are still waiting Xu hengqiu, director of Anhui food and drug administration, said in an interview: "there is a great pressure to complete the consistency evaluation within the specified time, but we have set up a working group, held an enterprise mobilization meeting, built a technical cooperation service platform for production, education and research, and established a strategic Alliance for consistency evaluation of imitated drugs in Anhui Province Now we have launched 10 varieties." The consistency evaluation of generic drugs is not only the improvement of drug quality, but also a shuffle of drug industry How many of the 187000 drug approval numbers are sleeping? In this shuffle, they will always be eliminated "We have more than 120 drug batches, 19 of which are listed in the basic drug catalog, but only three varieties are in production So this time we only want to do 5 varieties At present, we have started the consistency evaluation of 2 varieties, and we will not do the others " Ji Junqiu, chairman of Hefei cube Pharmaceutical Co., Ltd., told the newspaper "The cost of consistency evaluation for a variety is 5 million to 10 million If all of them are done, the amount of money is under pressure, and there is no need to do it," said Ji Some varieties are not competitive, or even not in production, so we don't have to do it, just do competitive in-process products " "There is a lack of talents for drug consistency evaluation in China, but they can entrust some scientific research institutions to do it, which is not impossible." Said experts in the pharmaceutical industry For he Guangwei, chairman of Hefei medical industry pharmaceutical Co., Ltd., who specializes in new drug research and development, this is undoubtedly an opportunity "In order to receive the entrustment of the conformity evaluation of generic drugs, our equipment has doubled and invested tens of millions At present, more than 20 varieties have been accepted for drug consistency evaluation " The consistency evaluation of generic drugs is a very complex system engineering, which not only needs to solve the problem of huge investment, but also needs to solve the three problems of what to do (selection of varieties), who to do with (independent research, commissioned research, cooperative research) and how to do it (reference preparation selection, reverse engineering research, prescription process improvement, bioequivalence research, etc.) There are many influencing factors and situations Extremely complex The most confusing thing for enterprises is the change of specifications "The original drug is a tablet You can't find the reference reagent even if you imitate it This is the most troublesome thing." A pharmaceutical industry person said "Many enterprises are struggling with how to choose the reference reagent Don't you know whose medicine you imitated? There is indeed a problem of insufficient clinical trial institutions A hospital can make 10 to 20 varieties in a year, because the clinical trial requires daily blood sampling and drug administration, and the procedure is rather cumbersome But the country has expanded the list of new clinical institutions that can do experiments " Said experts in the pharmaceutical industry At present, there are 53 medical institutions in phase I clinical trials, and the workload of consistency evaluation is still insufficient According to the insiders, due to the large number of clinical medical institutions needed, the next step may be to cancel GCP certification of clinical medical institutions and change it to record The above experts involved in the formulation of generic drug conformity evaluation program believe that "whoever does it first passes it first will benefit." In the future, priority will be given to the first three enterprises with the same type of essential drugs, which will not enjoy the preferential policy if they get the same type of essential drugs At present, the country has determined the varieties and batch numbers that do not do conformity evaluation, which will be cancelled and cannot be reproduced This article will be implemented to the end "