The consistency evaluation must be speeded up when the pharmaceutical export enterprises seize the domestic market

On June 1, CDE publicized the list of the 18th batch of varieties to be included in the priority review 12 acceptance numbers from four enterprises, including Xiansheng Dongyuan, Zhengda Tianqing, Shiyao Ouyi and dongyangguang, were selected, involving five common clinical varieties, such as bendamostine, clopidogrel, metformin, clarithromycin and levofloxacin The eighteenth batch of drugs to be included in the public list of drug registration applications for priority review procedures The reasons for the above varieties to be included in the priority review are in line with the policy of "scope of priority review and approval" in CFDA's opinions on solving the backlog of drug registration applications issued on February 26 last year Application for registration of drugs produced in the same production line in China and simultaneously applied for listing in the United States and European Union drug approval agencies and passed their on-site inspection The self-examination and verification items listed in the announcement on carrying out the self-examination and verification of drug clinical trial data (No 117, 2015 of the food and Drug Administration) were withdrawn by the applicant and changed to the generic registration application that was re declared after being improved according to the standard consistent with the quality and efficacy of the original research drug; Among them, Nanjing xianshengdongyuan and zhengdatianqing's benzamoxetine for injection were all reported as class 3.1 new drugs before After withdrawal in the 7.22 clinical self-examination, they were reported as class 4 generic drugs again, and obtained the priority approval qualification by virtue of the first generic identity of different indications This is the second time that ibuprofen injection appears after "ibuprofen injection" in the 10th batch of priority review list and gets priority review on the basis of "withdrawal of varieties in clinical self-examination, consistent with the original research drug" In this batch of priority review list, three varieties produced by the same production line at home and abroad are of most concern, including clopidogrel bisulfate tablets (listed in the United States in 2017), metformin hydrochloride sustained-release tablets (listed in the United States in 2016), and clarithromycin tablets (listed in the European Union in 2016) which have been listed in the European Union by Dong Yangguang Clarithromycin sustained release tablets (listed in 2015 EU), levofloxacin tablets (listed in 2014 EU) In addition, montelukast sodium tablets / chewable tablets (abison) and valsartan tablets (Huahai) listed in the 12th batch of priority review list, which are "produced in the same production line, listed in the United States, and listed in the application country", bensulfosaatracurium injection (Hengrui) and metformin hydrochloride tablets are listed in the 15th batch of priority review list We can observe the following trends: CDE's description of the reasons for the priority evaluation of such varieties is becoming more and more clear, including the production of the same line, foreign listing regions and listing years More sufficient information means that the reasons for the priority review are irrefutable For example, as shown in the figure below, several domestic and foreign co production line varieties other than clopidogrel, which are to be included in the priority review list announced by CDE this time, do not seem to have any objection At present, the policy dividend of "priority review can be obtained for the application of export preparations for listing in China" is mainly enjoyed by Huahai, Hengrui, Shiyao, dongyangguang and other first batch of domestic pharmaceutical enterprises that carry out preparations internationalization business Their product line layout and experience in preparations internationalization are more abundant The benefits of internationalization of preparations have been deeply realized by more preparation export enterprises The listing applications of metformin hydrochloride tablets, metformin hydrochloride sustained-release tablets and clopidogrel bisulfate tablets have been included in the priority review, In particular, clopidogrel was only approved by FDA on February 2, and the domestic listing application was accepted on March 31, 2017 This shows that Europeand of petrochemicals wants to use the policy to transfer to China before clopidogrel is approved by FDA It can also be inferred that petrochemicals will probably report all export products in China For example, Dong Yangguang, the levofloxacin tablets listed in the European Union in 2014 and the clindamycin sustained-release tablets listed in the European Union in 2015 reapplied for listing in China after several years (both obtained CDE on March 14, 2017), which was obviously aware of the benefits of the policy As mentioned in the previous article, "stone medicine and Hengrui are out of talent, and the time left for metformin" may not be much longer ", this kind of domestic and foreign co production variety can not only speed up the listing in China with the help of" priority review ", but also more importantly, the approval of listing is regarded as further enjoying the benefits of bidding and procurement through consistency evaluation It's no surprise that there will be more enterprises like dongyangguang in the future, and export preparations like clopidogrel will turn to the domestic market one after another Now there is a key question What other qualified export preparations will be killed back home? Especially for the 289 varieties that need to complete the consistency evaluation within the specified time, it will be a terrible thing if the opponents have all been killed and don't know it For example, "montelukast natrium chewable tablets" is not a 289 product, there is no pressure to complete the consistency evaluation by the end of 2018, and there are only two domestic manufacturers, just like a good situation However, it should be noted that the montelukast sodium chewable tablets (cyhs1600088) of abison have been reviewed preferentially and are currently in the process of "being reviewed and approved", while the montelukast sodium chewable tablets of Eucalyptus obtained FDA approval on April 18 (see: the montelukast sodium chewable tablets of Eucalyptus obtained FDA approval), According to the current strategy of petrochemicals, it is also sooner or later to apply for listing in China and obtain priority review If anbisheng and Shiyao's montelukast natzui chewable tablets are listed on the market and deemed to pass the consistency evaluation, Lunan and Sichuan Otsuka will have no worries After all, the national policy documents stipulate that if there are more than three manufacturers 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 terms of centralized purchase of drugs Finally, it is necessary to remind that metformin hydrochloride tablets and clopidogrel bisulfate tablets, two varieties that need to complete the consistency evaluation before the end of 2018, involve 116 and 6 drug numbers respectively according to the statistics of the National Bureau The varieties of preparations exported have been killed back Domestic enterprises need to speed up