The latest conformity evaluation of generic drugs passed the summary of product specifications: the acceptance number exceeded 200

During this year's NPC and CPPCC sessions, Ma Xiaowei, director of the National Health Commission, said that the "4 + 7" volume procurement will further expand its scope and spread to the whole country, and this work will continue Under the comprehensive effect of "4 + 7" volume procurement and butterfly effect, domestic generic drugs will enter the era of price war So, what is the current status of generic conformity assessment declaration? In the future pattern of generic drugs, are there any opportunities for SMEs? Next, we will review the specific progress of generic conformity assessment in March 2019 with GBI source database 1、 As of March 27, 2019, 21 new generic drug conformity regulations passed the generic drug conformity evaluation Among them: 11 products are 289 catalogue varieties In March, amlodipine besylate tablets (5mg) of Yabao Pharmaceutical Co., Ltd and Beijing Wansheng Pharmaceutical Co., Ltd passed the consistency evaluation of generic drugs, and the number of manufacturers of amlodipine besylate tablets (5mg) reached 8 2、 According to the GBI source database of new deemed passed generic drug conformity assessment in March 2019, as of March 27, 2019, three new deemed passed generic drug conformity assessment in March 2019 have not been included in the catalogue of Chinese listed drugs 3、 Up to now, there are 14 enterprises that have passed the conformity assessment of generic drugs or deemed to have passed the conformity assessment of generic drugs Among them: Amlodipine Besylate tablet (5mg) has 8 passes; rosuvastatin calcium tablet (10mg) has 5 passes; montmorillonite powder (3G), amoxicillin capsule (0.25g), metformin hydrochloride sustained-release tablet (0.5g), entecavir capsule (0.5g) At present, 4 enterprises have passed the evaluation of generic drug consistency in 6 specifications of Mg, tenofovir dipivoxil fumarate tablets (0.3g), cefuroxime dipivoxil fumarate tablets (0.25g); 6 specifications of 3 enterprises are: atorvastatin calcium tablets (10mg), escitalopram oxalate tablets (10mg), entecavir dispersible tablets (0.5) Mg), risperidone tablets (1mg), metformin hydrochloride tablets (0.25g), polyethylene glycol 4000 powder (10g) 4、 According to GBI source database, as of March 27, 2019, the cumulative acceptance number of CDE's generic conformity assessment has reached 1025, involving 254 varieties of 334 enterprises, and 219 products have passed or deemed to pass the generic conformity assessment Among them, there are 8 enterprises that have passed the regulations, 5 enterprises that have passed the regulations, 4 enterprises that have passed the regulations, 3 enterprises that have passed the regulations, 2 enterprises that have passed the regulations, and 1 enterprise that has passed the regulations (see the table below for the detailed list) 5、 From 2018 to now, according to the results of GBI source database [drug declaration statistics] tool statistics, CDE has accepted 59 new applications (data statistics as of March 27) for generic drug conformity assessment in March 2019, with no growth compared with last month Driven by the national policy of volume purchase, the traditional mode of drug purchase is changing, and many API enterprises have to reduce prices in order to keep the market Under the follow-up influence of "4 + 7" volume purchase, the original research enterprises that were not selected had to take the initiative in price reduction On the one hand, we should face the competition of the original research enterprises, on the other hand, with the increase of the evaluated enterprises, the competition among the generic pharmaceutical enterprises is also increasing day by day In this regard, some insiders said that the survival pressure of some domestic enterprises without conformity evaluation will be further increased, either transforming or selling For the generic pharmaceutical enterprises, the industry concentration is an inevitable trend in the future.