[follow up analysis] six withdrawal items of clinical self-examination were restarted by be test. How about the progress of consistency evaluation?

Affected by the withdrawal of nearly 70% of the acceptance number of the clinical self-examination, the approval of the production approval is also bleak According to the data of the new approval published by CFDA in 2016 every month, 84 production approval documents were approved in January to may, all of which are chemicals; only 4 with new drug certificate, 3 of which are APIs and 1 preparation Then, the only remaining preparation product is the nanofloxacin malate capsule, which is registered as a chemical 1.1 declaration and belongs to one of the few survivors in 1622 clinical self-examination checklists When the project prospect risk is difficult to judge, the new project establishment is in the selective difficulty Many enterprises choose the existing policy support direction as their own establishment direction, and the projects withdrawn through self-examination and verification and consistency projects are the most concerned by enterprises at present Through the analysis of the clinical application status of the above two projects in 2016, we can understand the current situation of enterprises' response to the above two projects As of June 26, 2016, 916 acceptance numbers were withdrawn through announcement, accounting for 56% of 1622 acceptance numbers Among the 916 acceptance numbers, there are 805 manufacturers and products with withdrawal announcement, among which 6 manufacturers and products restart bioequivalence test : lamivudine tablets of Shijiazhuang Longze Pharmaceutical Co., Ltd withdrawn on No 255 in 2015, tinifovir dipivoxil fumarate tablets of Zhejiang Nanyang Pharmaceutical Co., Ltd withdrawn on No 287 in 2015, tinifovir dipivoxil fumarate tablets of Zhengda Tianqing Pharmaceutical Group Co., Ltd withdrawn on No 21 in 2016, drospironone alkyne of Hangzhou tiger Pharmaceutical Technology Co., Ltd Estradiol tablets and pramipexole hydrochloride tablets of Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd., and retagliptin phosphate tablets of Jiangsu Hengrui Pharmaceutical Co., Ltd withdrawn by Announcement No 109 in 2016 1 the announcement of Shijiazhuang Longze pharmaceutical lamivudine tablets was withdrawn without mentioning the clinical trial institution In 2016, the newly launched bioequivalence test was 300mg, and the reference preparation was UK Glaxo Wellcome Lamivudine produced by operations (trade name: yipingwei) was launched in Beijing Shijitan Hospital, affiliated to Capital Medical University The participating institutions include Beijing bozhiyin Technology Co., Ltd., Covance pharmaceutical R & D (Shanghai) Co., Ltd., Beijing bonoway Pharmaceutical Technology Development Co., Ltd and Beijing Jingwei Chuanqi Pharmaceutical Technology Co., Ltd 2 The clinical trial of tenofovir dipivoxil fumarate tablets was carried out in Xiangya Third Hospital of Central South University In 2016, the new test was carried out in the phase I clinical trial Laboratory of the first hospital of Jilin University to carry out the bioequivalence test of postprandial and fasting, with the test specification of 300mg No information about the participation of other cro institutions has been found The reference preparation is tenofovir dipivoxil fumarate tablets of GSK (trade name: Werder) 3 the former clinical trial institution of Zhengda Tianqing Pharmaceutical Co., Ltd of tenofovir dipivoxil fumarate tablets is the First Affiliated Hospital of the Fourth Military Medical University of the people's Liberation Army of China In 2016, the new trial was also carried out in phase I clinical laboratory of the first hospital of Jilin University The test specifications, reference preparations and contents are basically the same as those of Nanyang, Zhejiang Province Although Zhengda Tianqing announced its withdrawal later than Zhejiang Nanyang, it carried out bioequivalence test earlier than Zhejiang Nanyang, and now has recruited and completed the subjects 4 The original clinical trial institution of drospironone ethinylestradiol tablets of Hangzhou tiger medicine was carried out by Xiangya Third Hospital of Central South University In 2016, the new test was also a bioequivalence test of postprandial and fasting in phase I clinical laboratory of the first hospital of Jilin University The test specification was 3mg drospirone and 0.03mg ethinylestradiol per tablet No information about the participation of other cro organizations was found in this test Developed by exceltis Magyarorszag KFT And produced by laboratorios Le ó n Farma, S A.; the reference preparation is produced by Schering GmbH & Co produktons kg, Germany The former clinical trial institution of Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd pramipexole hydrochloride tablets is TEDA International Cardiovascular Hospital The trial carried out in June 2016 was also carried out in phase I clinical trial and research room of the first hospital of Jilin University The original drug senflor produced by bolingyinhan company was used as the reference preparation, with the specification of 0.25mg 6 The original clinical trial institutions of Jiangsu Hengrui pharmaceutical and repagliptin phosphate tablets include Shanghai Long March Hospital, General Hospital of the people's Liberation Army, Chengdu General Hospital of the people's Liberation Army, Qilu Hospital of Shandong University, etc In April 2016, the experiments were carried out successively: food effect pharmacokinetics, material balance and metabolite identification in healthy volunteers, single and multiple oral administration in healthy subjects, single arm, open, single and multiple oral administration in type 2 diabetes patients Pharmacokinetic study and drug interaction study with simvastatin tablet (Shujiangzhi); drug interaction study with valsartan capsule and metformin hydrochloride tablet (gehuazhi) respectively in Clinical Pharmacy Laboratory of Chengdu Military General Hospital The specifications of the study are mainly 100mg, and only 50mg and 100mg will be studied simultaneously in the pharmacokinetics study of single and multiple oral administration In the self-examination and verification list, it was found that the bioequivalence test was not included in the withdrawal list of the announcement, but also started recently: bosentan tablet of Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd and lenadelamine capsule of Beijing Shuanglu Pharmaceutical Co., Ltd The test of bosentan tablet of Zhejiang medicine Xinchang pharmaceutical factory was carried out in the Clinical Pharmacology Center of the Second Affiliated Hospital of Zhejiang University Medical College in April 2016 The reference preparation is the listed bosentan tablet (all available), and the test specification is 125mg Lenalidomide capsule (25mg) of Beijing Shuanglu Pharmaceutical Co., Ltd was launched in Beijing Shijitan Hospital Affiliated to Capital Medical University in May 2016 The reference preparation is lenalidomide capsule (25mg) Summary of 805 manufacturers and products withdrawn, only 6 manufacturers and products restarted bioequivalence test, accounting for less than 1% Most of the restarted projects were carried out in phase I clinical laboratory of the first hospital of Jilin University, followed by Beijing Shijitan Hospital Affiliated to Capital Medical University How many conformance tests have been carried out? From June 21 to 22, 2016, CFDA held a meeting in Beijing on the consistency evaluation of quality and efficacy of generic drugs, implemented the opinions of the State Council on the consistency evaluation of quality and efficacy of generic drugs, and further promoted the reform of drug review and approval system Once again, the meeting stressed that the main responsibility of consistency evaluation is the enterprise The enterprise should select the most reliable varieties and carry out the consistency test as soon as possible 289 products in total belong to the catalogue of generic drug conformity evaluation varieties to be completed by the end of 2018 mentioned in the announcement of the General Administration of the State Council on implementing the relevant matters of the opinions of the general office of the State Council on the implementation of generic drug quality and efficacy conformity evaluation (2016 No 106) on May 26, 2016 In the above list, and in 2016, three new products were tested, namely amlodipine besylate tablets, metformin hydrochloride tablets, and lamivudine tablets of Shijiazhuang Longze pharmaceutical mentioned above None of the three products is the bioequivalence test related to the conformance test declared by the listed manufacturers at present Amlodipine besylate tablets and metformin hydrochloride tablets are the bioequivalence tests declared by the applicant manufacturers for listing corresponding to the six kinds of clinical approvals approved by CDE in 2015 Amlodipine besylate tablets were declared by Xi'an Gelan Xintong Pharmaceutical Co., Ltd and selected amlodipine besylate tablets (trade name: luohuoxi) from Pfizer Pharmaceutical Co., Ltd as reference preparation to carry out bioequivalence test in Affiliated Hospital of Liaoning University of traditional Chinese medicine Metformin hydrochloride tablets are declared by Ouyi Pharmaceutical Co., Ltd of Petrochemicals Group, and take the metformin hydrochloride tablets (trade name: gehuazhi) produced by Shanghai Shiguibao Pharmaceutical Co., Ltd of China and the United States as the reference preparation The bioequivalence test is also carried out in the first hospital of Jilin University Summary in the current public information query, we do not see the listed manufacturers applying for conformance test However, the new clinical approval manufacturers need to be consistent to obtain the production approval If all the above three products are approved, it means that non current listed manufacturers gain the competitive advantage of "coming from behind" through consistency test There is always a lag in the information of project declaration From the list of product projects of enterprises that re declare and re start immediately after withdrawal of clinical self-examination, we can know which enterprises have confidence in their own projects As soon as it is withdrawn, it will be tested immediately, which means that these enterprises believe that as long as the relevant tests are supplemented, the prospect is still promising On the other hand, from the fact that 99% of the projects returned through self-examination and verification have not yet been applied for clinical projects again, and that the consistency test still requires the mobilization of enterprises by the General Administration, it can be seen that most of the projects previously approved by most enterprises still need to be improved in terms of technical level At present, many enterprises are faced with "selection difficulty", which projects are to be abandoned and which are to be guaranteed are still in tangle In fact, the competitive environment is not closed In addition to the competition among the listed manufacturers, there is also the competition among the domestic manufacturers after the four kinds of be clinical record system of new chemical classification Even some foreign generic pharmaceutical manufacturers listed in Europe and America are looking for the path to enter the generic pharmaceutical market in China to participate in the competition For domestic enterprises, the consistency test needs to increase the construction of production lines, etc., while thinking about how to share the cost, we can consider the possibility of the export of Relevant generic drugs to foreign markets (for example, Japan recently proposed that the market share of generic drugs should rise to 80%), and we can also consider obtaining the production license of foreign generic drug manufacturers listed in Europe and the United States