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

Author:May 14, 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, with dosage form as injection, injection microsphere, injection liposome, injection emulsion, injection micro-milk, marketing number in use, drug type for chemical imitation, search for listed drug database, a total of 30,667 code (involving 1000 enterprises) need to carry out a consistency evaluation (Species that do not require a consistency evaluation, such as sodium chloride injections), as of May 14, a total of 1010 (by file and reporting) were approved/as a result of consistency evaluation, submission of supplementary applications, BE trials, filing and declaration of 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 screening agent forms were injectables, microspheres for injections, lipids for injections, injections, micro-emulsions, including 849 injections, including a total of 849 injections, including a total of 849 injectionsTherefore, everything is only under the east wind, injection imitation drug elimination began to accelerateimage source: Insight databaseof the 31 injectable varieties that have been evaluated so far, only Hainan Pulis Pharmaceuticals' injection azithromycin through consistency evaluation, the rest are treated as passed;data source: Insight databaseNotes: The database shows 33 varieties, which are counted according to the drug name, and here the compound amino acid injections III, IX, VII, 3 specifications are counted as 1 speciesin the Insight database's reporting progress library, the screening dosage forms are injections, injection microspheres, injectable liposomes, injection emulsions, injection micro-milk discoveries, a total of 723 acceptance numbers (involving 135 varieties) are currently submitted for consistency evaluation supplementation applications, 1 of which have been The approval was approved through the consistency evaluation (Hainan Puli injection azithromycin), 1 approved for clinical development (Guangdong Gabor Pharmaceutical's propofol/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 varieties that submitted the most applications for consistency evaluationSource: Insight databaseof these 718 acceptance numbers, the earliest of these 718 processing 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 very much look forward toas early as December 2017, CDE released the Technical Requirements for The Conformity Evaluation of Listed Chemical Recombinations (Injections) and publicly solicitedcomments; In November 2019, 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 reporting materials for comments; 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 data sources: Insight database According to the time of cDE, 142 acceptance numbers for 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 source: Insight database in the "Technical Requirements for the Evaluation of The Conformity of Chemical Injection Sufixation Sugenerics" published by CDE on May 14, it is clear: sodium chloride injections, glucose injections, sodium glucose chloride injections, injecting 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 and package selection (including compatibility) and other relevant technical requirements 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 yangzijiang pharmaceutical right metomin injection in 4 plus 7 sets of brilliant, counterattack or even reverse the market pattern; consistency evaluation is a game.