Monthly report of consistency evaluation: application slows down, over evaluation welcomes good results, and injection Prelude officially opens

Guide reading 1 List of varieties passing the consistency evaluation in March 2 Overview of overall progress of consistency evaluation 3 Statistics of varieties passing 3 (or more) 4 Top 10 enterprises passing the acceptance number According to the statistics of pharmaceutical intelligence data, in March, there were 22 Acceptance numbers that passed the consistency evaluation, involving 15 varieties and 15 application enterprises, among which 10 varieties were first passed (marked with red in the table), and the number of two varieties passed reached three (amlodipine besylate tablets of Yabao Pharmaceutical Group Co., Ltd and cefuroxime ester tablets of Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd.) 。 List of varieties passed consistency evaluation in March According to the statistics of drug registration and acceptance database, as of March 31, 2019, the acceptance number of declaration conformity assessment has reached 1018, involving 313 varieties, and the total number of declaration enterprises is 335, of which 169 have passed the conformity assessment, and the declaration is conducted according to the new registration classification of chemical drugs, and 68 are deemed to have passed the conformity assessment, with a total of 237 Overview of the overall progress of consistency evaluation in recent half a year, monthly consistency evaluation undertaking / analysis of the number of passes, monthly consistency evaluation undertaking dosage form analysis in recent half a year In March, there were 62 new acceptance numbers of CDE conformity assessment, which was the lowest in nearly half a year Especially compared with January this year, there was a significant decline, only about a third of January From the perspective of the review, there were 22 Acceptance numbers in March, only next to January 2019 In addition, from the perspective of the application dosage form, injection and oral solid preparations are becoming more and more flat Heng, accounting for 30%, can be seen that with the cancellation of the 289 deadline, and with the recent CDE release of the 21st batch of drug reference preparation catalog, the injection consistency evaluation will be officially launched, and enterprises have taken the lead in layout As of March 31, 2019, there are 14 varieties of 3 (or more) enterprises that have passed the consistency evaluation, all of which are oral solid preparations Three varieties (including deemed pass) passed the acceptance number enterprise TOP10 In March, four acceptance numbers of Sichuan Kelun Pharmaceutical Co., Ltd passed the consistency evaluation The total number passed 11, including two varieties of different specifications, acyclovir tablets: 0.1g/0.2g/0.4g and clindamycin hydrochloride capsules: 0.075g/0.15g According to the company's latest announcement on the conformity evaluation of fluconazole and acyclovir tablets by generic drugs, Sichuan Kelun Pharmaceutical Co., Ltd has invested about 3.89 million yuan in the conformity evaluation project of fluconazole and 7.92 million yuan in the conformity evaluation project of acyclovir tablets Sichuan Kelun Pharmaceutical Co., Ltd has passed the consistency evaluation catalog, which can be searched in the registration and acceptance database of smart drugs to check the detailed information: statement: this opinion only represents the author, not the position of smart drugs, 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.