[exclusive] latest progress of consistency evaluation: 1051 acceptance numbers, 183 passed, 65 deemed passed

As of April 17, 2019, the acceptance number of conformity assessment undertaken by CDE has reached 1051, totaling 319 varieties, involving 338 pharmaceutical enterprises, including 521 varieties in 289 catalogue, totaling 117 varieties There are 249 injection acceptance numbers, 86 varieties in total, involving 63 pharmaceutical companies At present, only azithromycin for injection has passed the consistency evaluation Table 1: overview of consistency evaluation undertaking 1 Analysis of acceptance varieties: since July 2017, enterprises have applied for consistency evaluation in succession The number of acceptance of consistency evaluation in each month can be seen that the number of acceptance of consistency evaluation has gradually decreased in recent months As shown in the figure below (calculated according to acceptance number): at present, 1051 acceptance numbers of consistency evaluation have entered the review: Amlodipine Besylate tablets have the most acceptance numbers, 37; Amoxicillin Capsules have the second acceptance number, 36 In addition, there are 129 varieties with only one acceptance number of conformity assessment If it can be approved quickly, it is expected to be the only variety passing the conformity assessment This part of the varieties will occupy an advantage in the bidding process and quickly gain market share Of course, we also need to pay attention to the newly declared varieties and the varieties for export to domestic sales Table 2: the most popular consistency evaluation varieties 2 The acceptance of provinces and cities currently includes 28 provinces and some foreign enterprises At present, Jiangsu Province has the most acceptance numbers, reaching 198 acceptance numbers, followed by Shandong Province, reaching 116 acceptance numbers Jiangsu Province, which has the most acceptance numbers, has reached 43, and Zhejiang Province ranks second, with a total of 30 acceptance numbers 3 At present, 338 enterprise consistency evaluation varieties have been accepted, but 154 enterprises have only one acceptance number At present, Qilu Pharmaceutical Co., Ltd has the largest number of acceptance numbers, reaching 48 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 65 in total The second is Kelun pharmaceutical, with 52 acceptance numbers in Sichuan Kelun, Hunan Kelun and Hubei Kelun In fact, the listed companies like Fosun Pharmaceutical have a large number of subsidiaries and a large number of acceptance numbers As of April 17, the acceptance number of the approved and deemed generic drugs has reached 248, 183 and 65 Among them, there are 99 289 catalogue acceptance numbers and only 50 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 In terms of drug passing, there are 18 enterprises that have passed the conformity assessment of product specifications, 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 have passed the most enterprise specifications, reaching 8 enterprises 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 There are also 23 enterprises that have passed the product regulation, and they are about to reach the tripartite confrontation Table 4: for the variety enterprises with 2 or more enterprises, 51 enterprises have more than 2 acceptance numbers and 49 enterprises have only 1 acceptance number The largest number of acceptance numbers is still Huahai pharmaceutical, reaching 17 acceptance numbers and 11 varieties Table 5: the first injection varieties appeared in the generic reference preparation catalog not long before the enterprises ranked by acceptance number It can be seen that a large number of injection varieties will be evaluated for consistency in the near future However, affected by the price of the 4 + 7 policy, the enthusiasm of enterprises slightly decreased The above data comes from the data of drug intelligence number (drug intelligence registration and acceptance database and China listing drug catalog set) It is stated that: the viewpoint of this article only represents the author, not the position of drug intelligence network, and you are welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.