Injection consistency evaluation start-up rate of only 3%! More than 29,000 signes are not progressing

Medicine Network May 26, 2020, the injection consistency evaluation officially launched, the expected thing does not seem to be unexpected, but to the domestic many injection series holders ate a heart-stopping pillAccording to Insight database statistics, the dosage form for injection, injection microspheres, injection liposomes, injection emulsions, injection micro-milk, marketage number in use,type of chemical imitation, search for listed drug database, a total of 30,667 code (involving1000) need to carry out a consistency evaluation (involving1000) Varieties that do not require a consistency evaluation, such as sodium chloride injections, were not excluded; as of 14 May, a total of 1010 (by file and reporting) were approved/as a result of consistency evaluation, supplementary applications, BE trials, filing and reporting of the parameters, with a start-up rate of only about 3%may have been delayed by the fact that the technical document had not been published, the reference preparations had not been published, but according to insight database statistics (https://db.dxy.cn/v5), the current official version of the reference preparations published by the National Drug Administration, the screening agent forms are injections, microspheres for injections, lipids, injections, injections, micro-emulsions, including 849 injections, including a total of 849 injectionsTherefore, everything is only under the east wind, injection imitation drug elimination began to acceleratePhoto Source: Insight databaseof the 31 injectable varieties that have been evaluated so far, only Hainan Pulis Pharmaceuticals' injection azithromycin passed the consistency evaluation, the rest are treated as passed
;data source: Insight databaseNotes: The database shows 33 varieties, according to the drug name statistics, here compound amino acid injection III, IX, VII3 specifications counted as 1 species135 varieties have been submitted for supplementary application, yes or no?in the Insight database reporting progress library, screening agent forms for injection, injection microsphere, injection liposome, injection emulsion, injection micro-milk found, currently submitted a consistency evaluation supplement request a total of 723 acceptance numbers (involving 135 varieties), of which 1 The approval has been approved through the consistency evaluation (Hainan Puli injection azithromycin), 1 approved for clinical development (Guangdong Gabor Pharmaceuticals propofol medium / long chain fat emulsion), the most important is that 718 acceptance numbers submitted the injection consistency evaluation supplement request has not yet reached the review conclusionsthe largest number of applications for consistency evaluation data source: Insight database of the 718 acceptance numbers, the earliest in 2018 to submit a consistency evaluation supplementary application, but at that time, the injection consistency evaluation is still in the consultation stage, for this stage of the enterprise to carry out the injection consistency evaluation, the National Drug Administration how to make the review conclusions we are very much looking forward to as early as December 2017, CDE released the Technical Requirements for The Conformity Evaluation of Listed Chemical Similarities (Injections) and publicly solicited comments ; In January, the State Drug Administration issued the Technical Requirements for the Evaluation of Conformity Quality and Efficacy of Chemical Injection Siucas (Draft for Comments) and the draft for comments on the declaration, and in November 2019, CDE published the Technical Requirements for The Conformity Evaluation of Quality and Efficacy of Special Injections (Draft for Comments) and, May 14, 2020, the full launch of the injection consistency evaluation technical document, marking the full launch of the injection consistency evaluation in 718 submissions to the acceptance number of consistency evaluation, a large number of enterprises are Colum Pharmaceuticals, Yangzijiang, Qilu Pharmaceuticals, China Biopharmaceutical, Hengrui and so on, involving more than 10 varieties 　Source: Insight Database According to the time of CDE, 142 acceptance numbers will be undertaken in 2018 and 415 in 2019; If, after the review, additional information is deemed necessary for the applicant, the applicant shall complete the supplementary information at a one-time cost within 4 months The time limit for the issuance of supplements shall not be included in the time limit for the review As a result, additional applications for consistency evaluations for 2018 and 2019 may be subject to the conclusions of the review in the near future data sources: Insight database in the May 14 CDE publication of the "Chemical Injection Imitation Quality and Efficacy Consistency Evaluation Technical Requirements" clearly: sodium chloride injection, glucose injection, sodium glucose chloride injection, injection water, some radioactive drugs (e.g radon (99mTc)) and other varieties do not need to carry out consistency evaluation, quality improvement research, sterilization process, filter processing and selection of relevant requirements (conformity) 　　Insight database shows that in the variety that has submitted a consistency evaluation supplementary application, involving sodium chloride injection, sodium glucose chloride injection, compound sodium chloride injection a total of 12 acceptance numbers, including enterprises have Colum pharmaceutical, Shandong Qidu pharmaceutical, Shijiazhuang four drugs However, no bioequivalence tests have been detected in the database for these varieties data sources: Insight database overall, injection consistency evaluation is still early, less varieties, if you can grasp the time of the first evaluation, it is possible to repeat the Yangzijiang Pharmaceutical right metomin injection in the 4 plus 7 sets of brilliant, counterattack or even reverse the market pattern; consistency evaluation is a game.