[Medicine heaven and earth] CDE talks again, a large number of drugs enter the elimination bureau? Hengrui, Huiyu, Yangzi River, Shiyao rush

On June 3, CDE released the catalogue of chemical generic reference preparations (the 22nd batch), which contains 238 injection references Prior to that, CDE published the catalogue of chemical generic reference preparations (the 21st batch), which includes 244 injection references According to the list of reference preparations published twice, the total number of injection reference preparations reached 482 Since December 22, 2017 and March 14, 2018, CDE has successively issued the notice on publicly soliciting the technical requirements for conformity assessment of listed chemical generic drugs (injections) and the technical guidance for research and development of drug injections, the industry has maintained a high degree of concern on whether the injection is subject to conformity assessment On March 28, 2019, CDE released the catalogue of chemical generic reference preparations (batch 21), including 224 injection references, involving 88 generic names of drugs This is the first time that the information of injection consistency evaluation reference preparation has been released at the national level, which has aroused a heated discussion in the industry Then on April 19, CFDI issued a notice on the on-site inspection plan for agatroban injection and parecoxib sodium injection On March 29 and 18, CFDI conducted on-site inspection on 7 products including ambroxol hydrochloride injection and 2 products including caffeine citrate injection According to the previous announcement of the State Food and drug administration, the object of the on-site inspection of the chemical generic injection is the application for registration of the generic injection under review and approval Once the relevant products pass the on-site inspection, it is expected to obtain the qualification for conformity evaluation soon Although the detailed rules for the consistency evaluation of injections and the landing time have not been issued at present, as we all know, injections / fluids have been one of the best-selling clinical dosage forms in China, but their safety has always been a headache to the regulatory authorities due to the inconvenient administration, complications and other defects With the further promotion of generic drug consistency evaluation and the overall improvement of drug quality threshold, it will be the general trend for injection consistency evaluation At the same time, in the process of policy gradually releasing signals, some domestic enterprises have taken precautions and taken the lead in the evaluation of injection consistency 01 according to the registration and acceptance database of smart drugs, 288 acceptance numbers of injections / fluids had been received by these enterprises as of May 27, 2019 At present, there are 9 injections that have passed the consistency evaluation (see the table below for details), as shown in the figure above Most of the over evaluated injections are deemed to have passed the consistency evaluation because they are included in the catalogue of Chinese listed drugs (Announcement No 172, 2017) According to the original CFDA Document No 100 issued in August 2017, it clearly supports the listing of drugs produced by Chinese domestic enterprises approved by the European Union, the United States or Japan in China, and emphasizes that the conformity evaluation is deemed to be passed after the approval of the common line variety review Therefore, by virtue of the policy, Sichuan Huiyu, Hengrui, Shiyao, Puli pharmaceutical and other enterprises have started the upsurge of internationalization and return of preparations Once the consistency evaluation of generic drugs "opens the gate" to the injection, those enterprises that connect with the international market will "ride the wind and break the waves" in the time of evaluation and the market layout of varieties 02 the products that have not been evaluated or have been evaluated are all "hard battles" or have not been evaluated According to the national and provincial policies and opinions on the consistency evaluation of oral solid preparations, the products that have not been evaluated will "struggle" in the market Only in May, Jiangxi, Guangxi and Jiangsu suspended a large number of enterprises that had not passed the evaluation of drug purchase qualification, involving hundreds of enterprises, including Hengrui, Baiyunshan, Huabei pharmaceutical, Huarun Shuanghe and other famous pharmaceutical enterprises In addition, on the way of cleaning up generic drugs without evaluation, the people's Government of Jiangsu Province held a seminar on encouraging innovation and safeguarding generic drug policies at the end of last year, during which it expressed that it would vigorously eliminate generic drugs with low quality, high repetition rate and failing to pass the consistency evaluation In addition to the "differential treatment" of the above policies, the status of the products without evaluation is far inferior to the products with evaluation On March 5, 2019, the State Medical Security Bureau issued the opinions of the State Medical Security Bureau on supporting measures for centralized drug procurement and use pilot medical insurance, which clearly stipulated that for generic drugs under the same generic name that failed to pass the consistency evaluation, the payment standard in 2019 should not be higher than the price of the selected drugs The medical expenses beyond the payment standard of medical insurance shall be borne by the insured The "anti price war" and "4 + 7" volume purchase of over evaluated products will become the mode of "reference" for all regions And the "Butterfly Effect" caused by it is not limited to the dosage form, variety and bidding area of the product As long as the product is in the field of purchasing with quantity, it can not avoid a "prisoner's dilemma" price war In terms of the first round of "4 + 7" volume procurement, two injection varieties deemed to have passed the consistency evaluation are included, namely pemetrexed injection and dexmedetomidine hydrochloride injection The two products were declared in accordance with category 4 imitation and Category 3 imitation respectively and were approved in 2018 The final bid price reductions were 66% and 29% respectively Among them, the bidding price of youmeituomi hydrochloride of Yangzijiang pharmaceutical was finally pulled to 133 yuan, which was also lower than the market bidding price As a result, the early layout of injection consistency evaluation enterprises, in compliance with the situation of volume procurement, the price may not have an advantage At the same time, Jiangsu Hengrui pharmaceutical applied for price reduction in Anhui Province for youmetomidine hydrochloride injection, a big selling product that failed to win the bid, shortly after the bidding result of 4 + 7 belt procurement was announced Then, Qilu pharmaceutical, Zhengda Tianqing, Jiangsu Hengrui, Shiyao, Jiangsu Haosen and other well-known domestic enterprises set off a price war to prevent the 4 + 7 winning enterprises from "occupying" the original market share Source: CDE, yaozhi.com, e-medicine manager, pharmaceutical economic news, etc