Consistency evaluation progress report! Ziru Pharmaceuticals has the most reviews, Amoxicillin is the most popular variety...

On May 14, 2020, the State Drug Administration issued the "Announcement of the State Drug Administration on the Quality and Efficacy Consistency Evaluation of Chemical Injection Imitation Drugs", marking the official opening of the evaluation of the consistency of injectionsThis paper will analyze the data from the perspectives of consistency evaluation overview, progress, evaluation of enterprises and variety number rankings.Theof Consistency EvaluationAs of 27 May 2020, the number of conformity evaluation accepted by CDE has exceeded 2000, reaching 2076, with a total of 497 varieties involving 546 enterprisesOf these, 735 injections were received, with a total of 158 varieties, involving 165 enterprisesTable 1: Overview of the consistency evaluation contractors
2076 generic drug consistency evaluation acceptance numbers, "in the review and approval" accounted for 66%, which included 697 injection acceptance numbers (there has been no prior injection consistency evaluation policy, there is a backlog)Figure 1: The progress of the consistency evaluation of the consistency of generic drug consistency evaluationthe acceptance number of the new contractor's consistency evaluation in May has reached 61, an increase of 30% month-on-monthAffected by the Spring Festival and the outbreak, the number of contractors decreased significantly from February to April, and began to rise in MayOf the 61 consistency evaluation acceptance numbers, 38 were injectable, accounting for 62.30 per centFigure 2: The number of acceptance slots for each month's consistency evaluationa total of 10 generic drug consistency varieties entered the contractor for the first time in May, including 7 injections and 3 oral solid preparationsTable 2: The first-ever consistent evaluation of varietiesconsistency evaluation ranking
a total of 2076 consistency evaluation acceptance numbers entered the review: Amoxelin capsules the most, the number of acceptance numbers is 54; In terms of adoption, a total of 577 acceptance numbers have so far passed the consistency evaluation The most tablets of hyposulphate chlorpyrifos and metformin hydrochloride were treated at 26, followed by amoxicillin capsules with 25 acceptance numbers (excluding the same number) Table 3: The most popular consistent evaluation varieties
a total of 285 acceptance numbers as passed by consistency evaluation, China's listed drug catalog has included 201 Hedarafi and Nedikave were treated as having the highest number of acceptances through a consistency rating, reaching nine acceptance numbers, followed by atorvastatin tablets and tegres, with eight acceptance numbers Table 4: As the same as through the consistency evaluation of varieties ranked a total of 546 enterprises consistent evaluation varieties into acceptance, but of which 238 enterprises are only 1 acceptance number The largest number of acceptance is Qilu Pharmaceutical Co., Ltd., there are 58, followed by Sichuan Kolun Pharmaceutical Co., Ltd and Shipharmaceutical Group Ouyi Pharmaceutical Co., Ltd., the acceptance number is 42 (Note: here according to the company name statistics, does not include the subsidiary acceptance number) Qilu Pharmaceutical Co., Ltd has the largest number, with 18 acceptance numbers Figure 3: The acceptance of the consistency evaluation of enterprises
a total of 30 provinces and cities are currently a total of 30 provinces and cities consistent evaluation varieties into acceptance The largest number of acceptance slot is Jiangsu Province, reaching 366 acceptance numbers, followed by Shandong Province, to 223 acceptance numbers Jiangsu Province, with the largest number of acceptances, reached 101, and Zhejiang Province, the second, by the number 71 From the provinces and cities to accept and through the situation, Jiangsu, Shandong, Guangdong occupied the top three, Zhejiang, Sichuan followed closely Figure 4: Acceptance of consistency evaluation in provinces and municipalities