942 latest reference preparations recorded in the first Bureau of the battle of life and death

Source: e drug manager 2016-09-14 September 12, China food and Drug Control Research Institute (hereinafter referred to as "CFDA") released the information disclosure of enterprise reference preparation filing, attached with two huge information forms, reference preparation filing and recommendation information - varieties and reference preparation filing and recommendation information - time These two forms sort out and summarize the reference preparation filing information submitted by pharmaceutical enterprises between May 20 and June 30 As of June 30, pharmaceutical enterprises have submitted 942 reference preparation filing information Within 40 days, such a large number of filing information has appeared intensively, which shows that pharmaceutical companies are "in a hurry" to file reference preparations People in the pharmaceutical industry are concerned about: what does this "large capacity" of public information mean? What signals are revealed by the variety information of many drug companies? Can pharmaceutical companies start to comprehensively promote the consistency evaluation after filing the reference preparation? 1 Nearly half of the non catalogue products have been put on record According to the comprehensive review of the contents by e drug manager reporters, 432 of the 942 reference preparation record varieties announced this time are not included in the previous 289 catalogue varieties Not long ago, CFDA has released 17740 approval numbers of 289 generic drug conformity evaluation varieties, which are the generic drug varieties that must be completed within the limit of 2018 What does this mean? According to the analysis of the insiders, nearly half of the number of reference preparations filed and declared means that a large number of varieties beyond the 2018 limit have been evaluated, not limited to 289 varieties listed earlier by CFDA There are also people in the industry joking that the varieties in the non 289 catalog have been so spelled What are the pharmaceutical enterprises waiting for with the varieties in the catalog? The consistency evaluation of generic drugs maintains the lifeblood of whether the generic companies can survive in the future market It is a common mentality to keep up with the times Yan Jie, vice president of Shenzhen xinlitai Pharmaceutical Co., Ltd., believes that at present, the selection of consistency evaluation varieties by pharmaceutical enterprises is not based on whether they are in the catalog, but on whether they are most valuable to the enterprise For some valuable varieties, the earlier they are, the better they will be for pharmaceutical enterprises Yan Jie told e pharmaceutical manager that when sorting out products, xinlitai pharmaceutical will not determine the priority of evaluation work based on whether the product is a base drug or not, but on its importance to the enterprise For example, clopidogrel is the top priority of the consistency evaluation of xinlitai, while the evaluation of azithromycin will be put in the back 2 "Diversified" selection of reference preparations from the perspective of the reference preparations selected by the record varieties, the vast majority of them have chosen the original products of foreign enterprises as the reference preparations, and some pharmaceutical enterprises have self certification as the reference preparations For example, 0.25g and 0.5g Pipemidic Acid Tablets of Shandong Xinhua Pharmaceutical Co., Ltd., 5mg of prednisone acetate tablets of Tianjin TIANYAO Pharmaceutical Co., Ltd., compound reserpine and nifedipine tablets of China Resources Shuanghe Pharmaceutical Co., Ltd., 50mg of colloidal bismuth pectin capsules of Shanxi Zhendong ante biopharmaceutical Co., Ltd., and 25mg of xinlitai pharmaceutical Co., Ltd Both clopidogrel bisulfate tablets and Pancreatic Kallidinogenase enteric coated tablets of Changzhou Qianhong Pharmaceutical Co., Ltd used their own varieties as reference preparations According to the data released by the Chinese Academy of inspection, it is found that different pharmaceutical companies choose different reference preparations for products of the same variety and specification Like 0.25g amoxicillin capsule, the reference preparations recorded by Harbin Pharmaceutical Group General Factory, Zhuhai United pharmaceutical and Sancai Shiqi pharmaceutical come from different manufacturers, including GSK, beechem group and tbva phaemaceuticals So, can the evaluation work be promoted after the reference preparations selected by pharmaceutical companies are filed, or do they need to wait for the unified reference preparations of the generic drug consistency evaluation office before proceeding? Yan Jie said that the approach of xinlitai pharmaceutical industry is: no doubt to promote in an all-round way, there will be disputes and so on Liu Chunguang, founder of Longtai investment, which focuses on the evaluation of generic drug consistency, told e pharmaceutical managers that according to the policy, if the original research is clear, the enterprise can start If it is controversial, such as changing the dosage form and the type of specifications, it is only proposed by the enterprise itself, and the enterprise is not willing to do it easily, but needs the approval of the generic drug consistency evaluation office Liu Chunguang said that the announcement of this filing by the China Inspection Institute also tells the industry about the filing of reference preparations in the current generic consistency evaluation, which makes pharmaceutical companies have a clear idea Another person familiar with the matter said that at present, some enterprises have been informed by telephone from the office of conformity assessment of generic drugs that the reference preparation is feasible At the same time, some problems have also been found in the filing For example, some pharmaceutical companies have made reference preparations for their own oral solutions and injection products However, at present, CFDA's relevant filing rules for the evaluation of injection preparations are still being further refined and standardized In addition, some enterprises make complaints about the choice of reference preparations, such as Hunan Warner pharmaceutical factory, which selects various domestic pharmaceutical companies as reference preparations For example, Colloidal Bismuth Pectin Capsules chose Shanxi's new treasure as reference, Bismuth potassium Citrate Capsules chose the Pearl Group Pharmaceutical Company as the reference But Lizhu medicine chose the tablet of Astaire as the reference preparation 3 Have you won the first competition? E drug manager combed the filing information and found that many varieties such as amoxicillin, azithromycin, omeprazole, quinoxal fumarate and other varieties have been filed by many manufacturers, which shows that the competition is fierce Taking amoxicillin as an example, including dispersible tablets, capsules and granules, there are 35 filing information, 8 of which are dispersive tablets, manufactured by Sinopharm group and Shanxi Tongda Pharmaceutical Co., Ltd., 22 capsules, 10 enterprises competing, and the filing reference preparations are also different; there are as many as 27 azithromycin dosage forms combined To this end, Yan Jie told e drug manager that the main reason for the competitive varieties of many drug companies, such as amoxicillin and azithromycin, is the large market scale Some kinds of enterprises that have been put on record are among the top few in market share, and it is not excluded that some kinds are big varieties of some small enterprises However, compared with the number of approval documents in CFDA database, the number of such reference preparations is still very small At the same time, for most of the varieties that have been published, excluding different specifications and dosage forms, there are only a few enterprises that have registered many varieties Taking aspirin enteric coated tablets as an example, at present, there are four pharmaceutical enterprises that have registered the reference preparations, namely Bayer pharmaceutical, Ouyi pharmaceutical of Petrochemicals Group, Pingguang pharmaceutical of Jiangsu Province and Xinhua Pharmaceutical of Shandong Province Some industry people think: for those that have been put on record, at least, these enterprises have begun to carry out work, and the previous work has been done more in-depth From this point of view, the relevant varieties of these enterprises have been at the front of the industry, and the varieties declared by these manufacturers are the ones that enterprises are eager to promote quickly Although the consistency evaluation of generic drugs is time-consuming and difficult, the enthusiasm of pharmaceutical enterprises to do the evaluation of generic drugs is unprecedented in terms of the information of reference preparations that enterprises have chosen At the same time, local governments are also increasing their support for the consistency evaluation of generic drugs On the same day that the Chinese Academy of inspection released the information of this case, the biomedical Department of Beijing Municipal Commission of science and Technology issued a notice that it would collect mature superior varieties for Beijing generic pharmaceutical manufacturers and provide financial support.