Progress report on the consistency evaluation of generic drugs in 2019

In 2019, the consistency evaluation of generic drugs entered the intensive harvest period, and the total number of acceptance numbers reached 1772 The injection consistency evaluation was speeded up again, and the State Food and drug administration asked for the technical requirements and application data requirements for injection consistency evaluation The number of enterprises that have passed the conformity assessment of 47 product specifications has reached 3, and the number of be tests registered in the conformity assessment of generic drugs has reached 1429 1 On March 5, 2016, the general office of the State Council issued the opinions on the evaluation of quality and efficacy consistency of generic drugs (GBF [2016] No 8), marking the comprehensive launch of the evaluation of quality and efficacy consistency of generic drugs in China In 2019, the State Food and Drug Administration and the drug evaluation center of its direct subordinate units issued a number of policies on the consistency evaluation of generic drugs On June 13, 2019, the State Food and Drug Administration issued the notice on Issuing the catalogue of generic reference preparations (the 21st batch), which first published the reference preparations for injection On October 15, 2019, the comprehensive Department of the State Food and Drug Administration publicly solicited opinions on technical requirements for conformity assessment of quality and efficacy of chemical injection generic drugs (Draft for comments) and application data requirements for conformity assessment of quality and efficacy of listed chemical injection generic drugs (Draft for comments) Finally, the conformity assessment of injection was speeded up and will be launched in an all-round way Table 1 main policies for conformity assessment of generic drugs in 2019 2 Acceptance and passing of conformity assessment of generic drugs as of December 31, 2019, the total number of acceptance of conformity assessment of listed generic drugs has reached 1722 acceptance numbers, including 557 acceptance numbers of injection conformity assessment In 2019, the acceptance number of generic drug conformity assessment contractors reached 1038, an increase of 69.61% year on year The number of acceptance numbers passed was 237, with a year-on-year increase of 111.61% Figure 1: among 1772 acceptance numbers of acceptance and passing of conformity assessment of generic drugs, amoxicillin capsule has the most acceptance numbers with 47 acceptance numbers, followed by amlodipine besylate tablets with 42 acceptance numbers Through the aspect, amlodipine besylate tablets and metformin hydrochloride tablets are the most, with acceptance number of 14; montmorillonite powder and cefuroxime ester tablets are the second, with acceptance number of 12; amoxicillin capsule and rosuvastatin calcium tablets are the third, with acceptance number of 11 (approval here does not include deemed approval) up to now, the most popular conformity assessment varieties in Table 2 have undertaken 449 generic drug conformity assessment varieties, of which 150 varieties have only one acceptance number Amoxicillin capsule, amlodipine besylate tablets, metformin hydrochloride tablets and ceftriaxone sodium for injection ranked top in the number of undertakers Figure 2 At present, 473 enterprises have accepted the acceptance number of conformity evaluation varieties, but 206 enterprises have only one acceptance number Qilu Pharmaceutical Co., Ltd has the most acceptance numbers, up to 55; Sichuan Kelun Pharmaceutical Co., Ltd has the second acceptance number, up to 37 Jiangsu Hengrui, Sinopharm Ouyi and Yangzijiang Pharmaceutical Co., Ltd ranked third with 34 acceptance numbers The statistics are based on the company name, excluding the subsidiary acceptance number Figure 3 As of December 31, 2019, the list of acceptance numbers of generic drug conformity assessment of enterprises has been accepted by 29 provinces and cities Jiangsu Province has the most acceptance numbers, reaching 312; Shandong Province has 195 acceptance numbers, Guangdong ranks the third, with 144 acceptance numbers Figure 4 acceptance of consistency evaluation in all provinces and cities 3 According to statistics, the number of acceptance of the varieties deemed to have passed the consistency evaluation of generic drugs (generic drugs approved according to the new registration classification of chemical drugs) has reached 180, among which 111 are included in the catalogue of Chinese listed drugs Figure 5 generic drugs approved according to the new registration classification of chemical drugs (catalogue set of Chinese listed drugs) 4 Varieties passing through three varieties In terms of drug passing, there are 47 enterprises that have passed the conformity assessment of product specifications, the most of which are 5 mg amlodipine besylate tablets and 0.25 g metformin hydrochloride tablets, all of which are 14 enterprises; the second is 3 G montmorillonite powder, which is 11 enterprises Table 3: up to now, 1429 be tests have been registered in the conformity assessment of generic drugs The main pattern of the registered be tests is as follows: 1006 of the be tests have been completed, while 15% have not been recruited, and 26 clinical trials have been suspended The reason for the active suspension is that the product is listed as a reference preparation and no be test is needed Fig 6 be test status of generic conformity assessment from 2017 to 2019, it can be seen that the be test and the be test of generic conformity assessment reached the peak in 2018 due to the impact of generic conformity assessment In 2019, there were only 418 be tests for conformity evaluation of generic drugs, a year-on-year decrease of 34.79% Fig 7 be test in 2017-2019 6 Analysis of the list of reference preparations published by CFDA up to 2019, the State Food and drug administration has issued 22 batches of reference preparations, a total of 1899 specifications, including 402 specifications (141 varieties) of injection reference preparations In 2019, three batches of reference preparations were published The publication of the catalogue of the 23rd and 24th batch of reference preparations for comments has been completed, and the 23rd batch has been published in the National Bureau on January 7, 2020 It is reported that the catalogue of the 25th and 26th batch of reference preparations will be published soon, and the catalogue of the 27th batch of reference preparations will be summarized Figure 8from the list of 22 batches of reference preparations published by nmpa as of December 31, 2019, it can be seen that the largest batch is tablet, accounting for 57%; the second is injection, accounting for 21%; the third is capsule, and the number of other dosage forms is relatively small, oral solid system occupies the first and third place For the first time, 163 injections appeared in the 21st batch, and the number of injections in the 22nd batch of reference preparations increased further, reaching 239 in a single time Figure 9 proportion of each dosage form in the catalogue of generic reference preparations 7 As of November 2019, the CDE reference preparation filing platform has received 2620 reference preparation filing information, including the reference preparation filing of newly registered drugs and the reference preparation filing of generic consistency evaluation Figure 10 data source of the number of CDE reference preparation filing platform filing: the conclusion of the consistency evaluation technical seminar 2019, the volume procurement expanded to the whole country, and the second batch of volume procurement has been carried out Many provinces have issued bidding and procurement policies to encourage over evaluation, and many documents mention that "if there are more than three enterprises that have passed the consistency evaluation for the same kind of drugs, no more varieties that have failed the consistency evaluation will be selected in the centralized purchase of drugs" Various provinces and cities have introduced subsidy policies to reward the varieties passing the consistency evaluation, with the amount ranging from 500000 to 3 million The general trend of generic drug consistency evaluation is that in 2020, the injection consistency evaluation may be launched in an all-round way Data sources: Pharmaceutical intelligence data, China listed drug catalog, State Food and drug administration, and announcements of listed companies Mengmeng statement: this view only represents the author and does not represent the position of yaozhi.com 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.