The start-up rate of generic consistency evaluation is only 44.3%

The consistency evaluation of 4238 generic drugs is accelerating According to the policy, the generic drugs in the "289 catalog" must complete the conformity evaluation before December 31, 2018, otherwise the chance of being purchased by medical institutions will be lost According to the statistics of insight database of DXY, as of November 29, 2018, 44.3% of the generic drugs in the 289 catalog had started the consistency evaluation, and only 25 products of 20 varieties passed the regulations At the same time of giving up or worrying, many enterprises ask whether they can extend the final deadline "The consistency evaluation of generic drugs has made many pharmaceutical companies panic, lost their corporate strategy, and there is no sense to postpone it The consistency evaluation is to exclude the enterprises whose original clinical data are not standardized or whose own R & D capacity is in question." According to Shi lichen, director of Beijing Dingchen medical management consulting center, it is enough to have three or five manufacturers of a variety, and consistency evaluation is the most basic production premise for generic drugs in the future 289 20 varieties in the catalogue need to go through five steps: reference preparation filing, pharmaceutical research, be (bioequivalence) filing, be test and supplementary application Among them, be test is an important node signal for enterprises to prepare for declaration conformity evaluation Its significance is that it can be used to evaluate whether the effects (safety and effectiveness) of two drugs on patients with a disease are the same or similar This is the most critical and the most difficult problem for enterprises in the process of application conformity evaluation According to the insight database of DXY, there are 808 be tests in total, 382 of which have been completed and 9 have been suspended Among them, Shangyao group has the largest number of be test varieties, 32 in total, followed by Yangzijiang Pharmaceutical (20) and Fosun Pharmaceutical (16) The submission of supplementary application is the last step of the conformity evaluation of the enterprise's application for this variety With the time limit approaching, more and more supplementary applications have been submitted From the previous 10 or so to now, the average monthly number of applications is nearly 60 Among them, only in September and October, there were 81 acceptance numbers for supplementary applications, compared with 76 in November According to the final results, as of November 29, there were 569 acceptance numbers of conformity assessment undertaken by the drug evaluation center (CDE) of the State Food and drug administration, of which 126 were approved and 87 were approved, including 5 disapproved by Cefalexin and Cefradine of Baiyun Mountain, loxoprofen sodium of BCI, tacrolimus of Haizheng pharmaceutical, etc Among them, in the 289 catalogue (271 varieties in total, the names of which have been combined repeatedly), 20 varieties (25 specifications in total) have passed, 52 varieties have submitted supplementary applications to enter the final stage, 48 varieties are in be test, and another 58 varieties have no progress at present According to Huang Wei, director of insight database of dingxiangyuan, at present, the policies and processes in all links of generic drug consistency evaluation from reference be application bidding have been clear As of November 29, 2018, the startup rate of varieties in 289 catalog was 44.3%, and the established tasks could not be completed before the end of 2018 From the perspective of the enterprises that have passed the test, Huahai pharmaceutical is still the biggest winner At present, a total of 8 varieties including lisinopril tablets, irbesartan hydrochlorothiazide tablets and losartan potassium tablets have passed the consistency evaluation Next are Yangzijiang pharmaceutical and Qilu Pharmaceutical (4 varieties), Ouyi and Zhengda Qingtian (3 varieties) At present, there are only 11 enterprises with more than 2 varieties The policy of "open up and kill", but the market of varieties is worried For the varieties that pass the consistency evaluation of generic drugs, from the perspective of the national level incentive policies, appropriate support should be given in the aspect of medical insurance payment, and medical insurance institutions should give priority to procurement and clinical selection; encourage to replace the original research, drug manufacturers can mark in the drug specification and label; also have the opportunity to apply for central infrastructure investment, industrial fund and other financial support In terms of bidding, if more than three drugs of the same variety have passed the consistency evaluation, the drugs that have not passed the consistency evaluation will no longer be selected in terms of centralized drug procurement; in addition, the national health insurance bureau organizes 11 cities including Beijing and Shanghai to pilot the consistency evaluation with volume procurement, and 33 varieties of drugs will be purchased with 60% to 70% market share in exchange for enterprise price reduction The above-mentioned favorable policies are good news for the enterprises that hold the approved varieties, but for the enterprises that do not pass the varieties, the market of the non evaluated varieties is worrying, and many places have issued policies to "open up and kill" the non evaluated varieties For example, in Shanghai, on September 4 this year, the Shanghai food and Drug Administration issued the implementation opinions on deepening the reform and optimization of administrative examination and approval of "release and administration service", and those oral preparations in the national essential drug catalog that failed to pass the consistency evaluation will not be registered again The drugs that do not meet the requirements of oral solid preparations in the national basic drugs shall be eliminated On November 22, Jiangsu public resources trading center issued the notice on publicizing the suspension of procurement of drugs that failed to pass the quality and efficacy consistency evaluation of generic drugs Nine drugs were suspended from procurement, including amlodipine besylate tablets, montmorillonite powder, and rosuvastatin tablets (thin film coating), involving nine pharmaceutical companies On November 15, Guangxi pharmaceutical machinery centralized purchase network issued the notice on suspending the online trading qualification of some drugs that failed to pass the consistency evaluation As the same reason, there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation Nine drugs, involving amlodipine besylate tablets, escitalopram oxalate tablets, etc., are scheduled to suspend their online trading qualification in Guangxi since January 1, 2019 Four varieties of montmorillonite powder and cefuroxime ester tablets The Guangxi Zhuang Autonomous Region public resources trading center hopes that the hospital will promptly negotiate with the enterprises through consistency evaluation, and do a good job in the pre-determination and procurement of clinical drugs involving the suspension of online trading qualification varieties Will the conformity assessment be postponed? The support and opposition were accompanied by the reporter of Beijing News, noting that rumors about the extension of generic drug conformity evaluation continued On February 22 this year, someone asked in the new drug and information discussion board of the DXY Forum: "the progress of generic drug consistency evaluation is not very optimistic now I heard that it may be postponed to the end of 2019 Is it possible? The leader asked to confirm whether it was possible " Some people left a message saying that the accurate statement of the official channel is that before the end of 2018, a big census will be conducted, and then the real policy direction will be determined But it is not a denial of existing policies "As far as I know, it is possible to turn on the green light only when we strictly check the varieties that do not have any action, and the varieties that have been developed cannot be pushed forward when encountering practical difficulties Let your leaders be careful and don't take chances " At the Symposium of "voice responsibility" medical industry held during the two sessions this year, one of the collected suggestions of the pharmaceutical industry was that the time limit for the completion of the consistency evaluation of essential drugs should be appropriately relaxed, and the time limit for completion should be extended from the end of 2018 to the end of 2021 Clinical effectiveness tests and varieties with special circumstances should be carried out separately Before that, Zhu Liang, director of Beijing Office of Henan Furen Pharmaceutical Group, also told the reporter of Beijing news that consistency evaluation is a good decision-making, but the time is short and the enterprise is under great pressure The consistency evaluation in the United States, Europe and Japan has experienced 10-15 years "If it is delayed, it is not fair for the enterprises that have started the consistency evaluation work, which will cause no one to pay attention to it." Shi lichen pointed out that the consistency evaluation work in Europe, America and Japan has gone through a long time, which refers to the completion time of all chemical drugs 289 the varieties in the catalogue account for only about 6% of the total drugs, which will not affect the use of drugs, and there is no significance for the delay However, due to the lack of institutions capable of undertaking be test, some enterprises may not be able to line up for seven or eight months, and some enterprises may not be able to carry out conformity assessment temporarily because of no reference preparation These special circumstances are caused by objective reasons and should be specially considered and postponed.