Good medicine node! 289 catalog panoramic dialysis, Fosun win-win, 204 varieties not declared? This week, 6 varieties were reviewed, and

Time always slips away from our fingers We can't hold it We can't hold it It's too late to sigh 2018 will end quietly 2018 is the policy year and reform year of the pharmaceutical industry; it is a particularly critical year for consistency evaluation According to the requirements of the former State Food and drug administration, in principle, the consistency evaluation of the chemical generic oral solid preparations (2012 version) approved for marketing before October 1, 2007 should be completed by the end of 2018, i.e 289 catalogue drugs According to the statistics of drug registration and acceptance database, up to now, there are 658 acceptance numbers of CDE acceptance consistency evaluation, involving 226 varieties of 246 enterprises, of which 325 are acceptance numbers of 289 drugs, accounting for about 50% However, the number of varieties is only 85, accounting for less than 30% of the total 289 drugs, and only 25 have been evaluated, with a completion rate of only 8.65% In 2018, there are only four days left for the complete completion Let's review the work panorama of 289 catalogue drugs for application for conformity assessment in 2018 and the new trend of conformity assessment in the last week! 289 catalog drugs panoramic analysis and evaluation: 25 varieties, 4 standard drugs passed three According to the data of pharmaceutical intelligence, as of December 27, 289 catalog drugs have passed or deemed to have passed the consistency evaluation, with a completion rate of only 8.65% Among them, there are 3 enterprises that have passed the evaluation of 4 drug specifications, including amlodipine besylate tablets, Amoxicillin Capsules, montmorillonite powder and cefuroxime ester tablets; there are 2 enterprises that have passed the evaluation of 6 drug specifications; there are only 1 enterprise that has passed the evaluation of 15 drug specifications 。 The most popular drug is amlodipine besylate tablets Although there are 5 evaluated enterprises, there are still 39 enterprises for reference and filing, 20 of which have completed the be test and 17 enterprises have accepted the application; the next is amoxicillin capsule, 4 evaluated enterprises and 15 enterprises have accepted the application See the following table for more details on the progress of conformity assessment: 289 table of contents for details on conformity assessment of drug varieties that have been assessed note: the number of enterprises participating in the above table for filing, completing be test and applying does not include the number of enterprises that have been assessed applying (not assessed): 62 varieties, 11 varieties applying for more than 3 Enterprises According to the pharmaceutical intelligence data, so far, in addition to the 25 varieties that have been evaluated, 60 varieties have applied for conformity evaluation, and have been accepted by CDE; among them, 11 varieties have applied for 3 or more enterprises, 11 varieties have applied for 2 enterprises, and 40 varieties have only one enterprise; it is worth mentioning that ranitidine hydrochloride capsule is 289 that has not been evaluated for conformity evaluation There are 4 enterprises that have completed be test, followed by indapamide tablets, 8 enterprises that have applied for be test, and 11 enterprises have completed be test, which are the varieties exempted from be test at present, such as hydrogen carbonate tablets, polyethylene glycol 4000 powder, metoprolol tartrate tablets, etc 289 catalogue varieties that have completed the most be test have not been evaluated yet It can be seen that all pharmaceutical enterprises are actively working on the consistency evaluation of 289 drugs For more details of the progress of varieties, see the following table: the details of the consistency evaluation of 289 drugs that have been declared but haven't been evaluated have not been declared: 204 drugs, the road ahead is worrying In addition, 204 drugs have not yet been declared by enterprises, and the prospect is unclear It is said that the 18-year deadline in the industry will be delayed, but the policy has not been issued, and it is still inconclusive In recent years, consistency evaluation will obviously become the normal focus of the pharmaceutical industry In the promotion and development of domestic drugs, both efficiency and quality need to be guaranteed, waiting for the guidance of the next top-level design Enterprise: Fosun win win, 289 has the most applications and comments From the perspective of enterprises, Fosun Pharmaceutical has the most applications for 289 catalogue drugs, with 23 acceptance numbers and 13 varieties At the same time, it is also the one that has passed 289 catalogue drugs with the most number of enterprises The number of enterprises that have been evaluated has reached 5 It is alfacalcitol tablet, clindamycin hydrochloride capsule and potassium chloride granules of Chongqing Yaoyou, amlodipine besylate tablet of Yellow River in Jiangsu, azithromycin of Erye in Suzhou In addition, there are 13 acceptance numbers and 8 varieties of Kelun pharmaceutical, among which 3 varieties have been evaluated, namely, metronidazole tablets of Sichuan Kelun, clindamycin hydrochloride capsules and Amoxicillin Capsules of Hunan Kelun The top 5 drug declaration enterprises in 289 catalog know the panoramic progress of 289 catalog this year Let's briefly review the battle situation of consistency evaluation in this week and the last week of 2018! The new development of consistency evaluation this week: 6 varieties were over evaluated, 289 of which accounted for 5; 3 varieties will be the first to pass the customs This week (December 20 to December 27), the last week of 2018, the consistency evaluation was carried out in an orderly manner Five 289 catalogue drugs passed the Customs at the last moment, among which three varieties were first evaluated, namely paracetamol tablets of Chengdu pharmaceutical industry of Di'ao group, aripiprazole disintegrating tablets of Chengdu Kanghong pharmaceutical industry group, metronidazole tablets of Sichuan Kelun pharmaceutical industry, and montmorillonite powder In addition, three enterprises of conformity assessment of metformin hydrochloride sustained-release tablets, which are not included in the 289 catalogue, are fully integrated, and three varieties are about to be the first ones to pass the customs See the following table for details: details of conformity assessment and approval of this week new acceptance: 13 varieties have been undertaken again, more than 80% of which are 289 varieties In addition to the remarkable update of the review and approval status, it is worth mentioning that this week's application for acceptance has been accepted There are 13 varieties of 18 acceptance number that have been accepted by CDE Although the deadline has come, enterprises have not abandoned the application for conformity evaluation of 289 catalog drugs Among the 13 varieties declared this week, 11 are 289 varieties, amlodipine besylate tablets, captopril tablets and amoxicillin Capsule and other enterprises have already reached three or more, but still do not reduce the application See the following table for details: part of the information sources in this week's consistency evaluation acceptance details table: yaozhi.com and online public information data sources: yaozhi.com data statement: this point of view only represents the author and does not represent yaozhi.com's position, 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.