Progress analysis of consistency evaluation: 1417 acceptance numbers, 339 passed, Qilu win-win situation, amlodipine besylate tablets are the hottest, and there is a large space for the alliance to purchase drugs

Latest: on September 11, Zhejiang Jingxin Pharmaceutical Co., Ltd issued the announcement on simvastatin tablets passing the consistency evaluation Recently, the company received the approval document for supplementary drug application of chemical "simvastatin tablets" approved and issued by the State Drug Administration (hereinafter referred to as "the State Drug Administration"), which passed the consistency evaluation of generic drugs As of September 11, 2019, there are 1417 acceptance numbers of consistency assessment undertaken by CDE, 403 varieties in total, involving 413 pharmaceutical companies, including 419 injection acceptance numbers, 122 varieties in total, involving 92 pharmaceutical companies Table 1: overview of consistency evaluation undertaking 1 Analysis of acceptance varieties: since July 2017, there have been enterprises applying for consistency evaluation, and the number of undertaken consistency evaluation in each month It can be seen that in recent months, the number of acceptance of consistency evaluation has remained above the average As shown in the figure below (calculated according to the acceptance number): Figure 1: the acceptance number of monthly consistency evaluation is currently 1417, and the acceptance number of amlodipine besylate tablets and Amoxicillin Capsules is the most, with 41 acceptance numbers, followed by metformin hydrochloride tablets, with 33 acceptance numbers Through the aspect, amlodipine besylate tablets and rosuvastatin calcium tablets are in the first place, with acceptance number of 11; cefuroxime ester tablets are in the second place, with acceptance number of 10 Table 2: the most popular consistency evaluation varieties 2 The acceptance of provinces and cities as of September 11, a total of 28 provinces and some foreign enterprises have accepted the consistency evaluation varieties At present, Jiangsu Province has the most acceptance numbers, reaching 277 acceptance numbers, followed by Shandong Province, reaching 160 acceptance numbers Jiangsu Province, which has the most acceptance numbers, has 46, and Zhejiang Province ranks the second, with a total of 39 Judging from the acceptance and passing of various provinces and cities, Jiangsu, Shandong and Zhejiang still occupy the top three, followed by Guangdong and Sichuan Figure 2: acceptance of consistency evaluation in all provinces and cities 3 Currently, there are 415 acceptance enterprises, but 185 enterprises have only one acceptance number At present, Qilu Pharmaceutical Co., Ltd has the largest number of acceptance numbers, reaching 52 In addition, 14 acceptance numbers of its Qilu Pharmaceutical (Hainan) Co., Ltd and 3 acceptance numbers of Qilu Tianhe Huishi Pharmaceutical Co., Ltd have reached 69 in total The second is Kelun pharmaceutical industry, with 60 acceptance numbers of Sichuan Kelun, Hunan Kelun and Hubei Kelun Yangzijiang Pharmaceutical Co., Ltd ranked third, with its subsidiaries, receiving 49 numbers Figure 3: as of August 19, the number of acceptances of approved and deemed generic drug conformity assessment varieties reached 339 Among them, there are 252 accepted drugs, 101 varieties; 87 deemed approved drugs, 46 varieties (subject to the list of drugs listed in China) As a whole, there are 138 289 catalogue acceptance numbers, only 54 varieties From the perspective of time dimension, it can be roughly seen that the first batch of catalog that passed the consistency evaluation was published in December 2017 (the four acceptance numbers in July and September 2017 are deemed to have passed), and there are basically all varieties passed each month, reaching the maximum in December 2018, with a total of 45 acceptance numbers Figure 4: acceptance number of conformity assessment passed in each month (including deemed pass) In terms of drug passing, there have been 30 enterprises that have passed the conformity assessment, including rosuvastatin calcium tablets (the first three varieties), amlodipine besylate tablets, montmorillonite powder, cefuroxime ester tablets, escitalopram oxalate tablets, Amoxicillin Capsules, tenofovir dipivoxil fumarate tablets, etc At present, amlodipine besylate tablets of 5mg are the most approved products in 11 enterprises For the first time, the number of enterprises that have passed the statistics is three, namely olanzapine tablets (5mg, 10mg), olmesartan ester tablets and paracetamol tablets Table 3: on December 28, 2018, the announcement of the State Drug Administration on the evaluation of the consistency of quality and efficacy of generic drugs (No 102, 2018) mentions two important signals: 1 For the varieties included in the national essential drug catalog, there is no longer a unified time limit for evaluation 2 For generic drugs including basic drug varieties approved for marketing before the implementation of new registration and classification of chemical drugs, the consistency evaluation shall be completed within 3 years in principle for the same varieties of other drug manufacturers after the first varieties pass the consistency evaluation According to statistics, there are still 33 enterprises that have passed the product regulation, and they are about to reach the tripartite confrontation Table 4: in terms of varieties of enterprises with 2 enterprises, Qilu Pharmaceutical Co., Ltd with the largest number of acceptance numbers has 17 acceptance numbers and 13 varieties; Zhejiang Huahai Pharmaceutical Co., Ltd., the former champion, ranks the second, with 17 acceptance numbers and 11 varieties Table 5: the ranking of acceptance numbers of enterprises is based on the parent company Fosun Pharmaceutical, which has the largest number of acceptance numbers, has 23 acceptance numbers for its subsidiaries and subsidiaries; Qilu pharmaceutical, which has 22 Acceptance numbers; Huahai pharmaceutical, which has 17 acceptance numbers, ranks the third Through the variety data, the largest number is Zhengda Tianqing Pharmaceutical Co., Ltd and Qilu Pharmaceutical Co., Ltd., with 15 varieties; at the same time, it can be seen that each variety of Zhengda Tianqing has only one specification Table 6: the parent company passed the Acceptance Number Ranking In the last article, there was a message from the readers The yifeiwelun tablet of Huahai pharmaceutical also passed the consistency evaluation In fact, yifeiwelun tablet (specification: 50mg, 200mg, 600mg) produced by Huahai pharmaceutical industry was included in the list of generic reference preparations due to "transfer of original research technology" and entered the list of drugs listed in China, marking that yifeiwelun tablet passed the quality and efficacy consistency evaluation of generic drugs Table 7: varieties passing the consistency evaluation in the centralized purchase of drugs in the original research technology transfer varieties alliance region in the reference preparation catalog On September 1, Shanghai Sunshine purchasing released the document of centralized drug purchase in alliance region, which pointed out that on the basis of 4 + 7 cities and follow-up implementation of centralized drug purchase in provinces, the state organized relevant regions to form an alliance to carry out centralized drug purchase in cross regional alliance in accordance with laws and regulations The alliance areas include Shanxi, Inner Mongolia, Liaoning, Jilin, Heilongjiang, Jiangsu, Zhejiang, Anhui, Jiangxi, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Sichuan, Guizhou, Yunnan, Tibet, Shaanxi, Gansu, Qinghai, Ningxia, Xinjiang (including Xinjiang production and Construction Corps), excluding the 4 + 7 cities in the alliance area According to the centralized procurement document of the alliance, the bid winning mode of 25 expanded varieties will be changed from 4 + 7 exclusive bid winning to 3 enterprises with the lowest price to obtain the qualification for the proposed winning (less than 3 enterprises declared shall be subject to the actual situation), and the bidding shall be conducted with the 4 + 7 winning price as the highest point In this part, the drugs and corresponding enterprises in the catalog that pass the consistency evaluation can compete with the original research enterprises on the same platform There are 10 enterprises that have passed the consistency evaluation for the most procurement varieties, and only one enterprise that has passed the consistency evaluation for 21 product specifications Table 8: data sources of varieties passing the consistency evaluation in the drug centralized purchase catalogue of the alliance region: Announcement statement of listed enterprises in CDE China Drug Catalogue: this opinion only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; 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