Progress report on the consistency evaluation of generic drugs in 2019

Original: 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 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 consistency evaluation of generic drugs in 2019 As of December 31, 2019, the total number of acceptances of conformity assessment of listed generic drugs has reached 1722, including 557 acceptances 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 acceptance and approval of generic conformity assessment Among the 1772 acceptance numbers for consistency evaluation, amoxicillin capsule was the most, with 47 acceptance numbers; amlodipine besylate tablets was the second, 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 (pass here does not include deemed pass) Table 2 most popular consistency evaluation varieties Up to now, there are 449 varieties of generic drug conformity assessment, 150 of which 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 acceptance no of consistency evaluation of varieties At present, a total of 473 enterprises have accepted the conformity assessment 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 ranking of acceptance numbers of generic drug consistency evaluation of enterprises As of December 31, 2019, a total of 29 provinces and cities have accepted the consistency evaluation varieties 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 of provinces and cities According to statistics, there are 180 acceptance numbers deemed to have passed the conformity evaluation of generic drugs (generic drugs approved according to the new registration classification of chemical drugs), among which 111 are included in the catalogue of Chinese listed drugs Figure 5 generic drugs approved by new registration classification of chemicals (list of Chinese listed drugs) 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 quality regulations of 3 or more enterprises Up to now, 1429 be trials have been registered in the conformity evaluation of generic drugs The main pattern of the registered be trials is as follows: 1006 of them have been completed, 15% of them 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 Figure 6 test status of be test for conformity evaluation of generic drugs Looking at the be test from 2017 to 2019, it can be seen that the be test and the be test of the conformity assessment of generic drugs reached the peak in 2018 due to the impact of the conformity assessment of generic drugs In 2019, there were only 418 be tests for conformity evaluation of generic drugs, a year-on-year decrease of 34.79% Figure 7 be test in 2017-2019 As of 2019, the State Food and drug administration has issued 22 batches of reference preparations catalogue, with 1899 product specifications, including 402 injection reference preparations (141 varieties) 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 8 number of batches of nmpa published reference preparation catalogue From the catalogue of 22 batches of reference preparations published as of December 31, 2019, it can be seen that the largest is tablets, accounting for 57%; the second is injection, accounting for 21%; the third is capsule, the number of other dosage forms is relatively small, and oral solid preparations occupy 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 generic reference drug catalog As of November 2019, the CDE reference preparation filing platform has received 2620 reference preparation filing information, including reference preparation filing of newly registered drugs and reference preparation filing of generic consistency evaluation Figure 10 record quantity of CDE reference preparation record platform Data source: consistency assessment technology workshop