Another variety passed the consistency evaluation, and 324 varieties passed the consistency evaluation

On August 18, Shandong Xinhua Pharmaceutical Co., Ltd issued a notice: cetirizine hydrochloride (10mg), a wholly-owned subsidiary, was the first to pass the generic drug conformity evaluation Acceptance No.: cyhb1850119; original drug approval No.: gyzz h19900095 As of July 31, the R & D cost for the consistency evaluation project of cetirizine hydrochloride tablets was about 8 million yuan According to the data, on June 14, 2016, Xinhua Pharmaceutical (Gaomi) Co., Ltd filed the reference preparation of cetirizine hydrochloride tablets, filing No.: 2016060355 In August 2017, Xinhua Pharmaceutical (Gaomi) Co., Ltd filed the be of cetirizine hydrochloride tablets, and carried out the be test in Shengjing Hospital Affiliated to China Medical University from August 6, 2017 to January 12, 2018 under the scientific title of "randomized, open, single dose, self crossover human bioequivalence clinical study of cetirizine hydrochloride tablets" On July 26, 2018, the product was undertaken by the drug audit center of the State Drug Administration As of August 19, the acceptance number of the approved and deemed generic drugs has reached 324, the number of the approved and deemed generic drugs has reached 238, and the number of the approved generic drugs has reached 86 (subject to the list of Chinese listed drugs) Among them, there are 130 289 catalogue acceptance numbers and only 53 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 1: acceptance number of conformity assessment passed in each month (including deemed pass) In terms of drug passing, there are 26 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 (5mg) and tenofovir fumarate dipivoxil fumarate tablets (300mg) have passed the most number of enterprises, reaching 9 enterprises In this statistics, the first three enterprises to pass the number of enterprises are solinacin Succinate Tablets and trimetazidine hydrochloride sustained-release tablets Table 1: 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 34 enterprises that have passed the product regulations, and they are about to reach the tripartite confrontation Table 2: for the variety enterprises with 2 or more enterprises, Huahai pharmaceutical is no longer the one with the largest number of acceptance numbers, and Qilu pharmaceutical catches up with 17 acceptance numbers, while Qilu pharmaceutical has the largest number of acceptance numbers, reaching 12 Table 3: the ranking of acceptance numbers of enterprises is based on the parent company Fosun Pharmaceutical, which has the largest number of acceptance numbers, has 22 Acceptance numbers for its subsidiaries and subsidiaries; Qilu pharmaceutical, which has 20 acceptance numbers; Huahai pharmaceutical, which has 17 acceptance numbers, ranks the third As the varieties of each subsidiary have certain repetition, the number of varieties passed will not be counted here Table 4: the data of parent company ranking above through acceptance number are from CDE China list of listed drugs, announcement of listed companies and drug intelligence data Statement: this opinion only represents the author, not the position of yaozhi.com, 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.