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    Home > Medical News > Latest Medical News > [exclusive] consistency evaluation of generic drugs: in-depth analysis of 621 registered clinical trials

    [exclusive] consistency evaluation of generic drugs: in-depth analysis of 621 registered clinical trials

    • Last Update: 2018-08-24
    • Source: Internet
    • Author: User
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    With the introduction of the policy of "quality and efficacy evaluation of generic drugs", the attention of clinical trials has been increasing, and the data of drug clinical trial registration platform has been increasing rapidly As of August 22, 2018, the platform has obtained 9086 clinical trials with CTR number, of which 6410 have been publicized Up to now, 621 clinical trials have been registered in the conformity assessment of generic drugs The main pattern of clinical trials registered is as follows: as can be seen from the figure above, 134 clinical trials related to conformity assessment have been completed, and 42% of them have not yet been recruited Four clinical trials were suspended actively, except for ctr20171615, which was due to the change of the trial scheme, the other three were the reference preparations published by the original CFDA, so no additional study was needed 1 According to the statistics of the number of registered clinical trials for conformity assessment, we have screened out clinical trials for conformity assessment of generic drugs through the statistics of clinical trials from 2016 to 2018, comparing the drug listing information and registration information As of August 22, 2018, there are 621 clinical trials in total The figure below shows the statistical chart of the number of clinical registration of generic drug conformity assessment in each month: 2 The most concerned drugs in the clinical trials of conformity assessment According to the statistics of the drugs registered in the clinical trials of conformity evaluation, amoxicillin capsules were the most concerned drugs from 2016 to August 2018, with 33 clinical trials; amlodipine besylate tablets and metformin hydrochloride tablets were the second, with 31 and 30, respectively Amoxicillin Capsules, amlodipine besylate tablets, captopril tablets, glimepiride tablets, enalapril maleate tablets, risperidone tablets and other drugs have passed the consistency evaluation 3 In general, the number of be clinical registrations from 2016 to April 2018 is positively related to the overall strength of each enterprise Qilu Pharmaceutical Co., Ltd has the largest number of registrations with 14 registration numbers, followed by Yichang dongyangguang Changjiang Pharmaceutical Co., Ltd and the third is Ouyi Pharmaceutical Co., Ltd Top 10 enterprises are almost large domestic pharmaceutical enterprises It can be seen that large pharmaceutical enterprises pay more attention to the consistency evaluation of quality and efficacy of generic drugs, and show strong strength It is mentioned here that Ouyi Pharmaceutical Co., Ltd., the third ranked group of Sinopharm, as a subsidiary of the old pharmaceutical company Sinopharm group, has made remarkable performance in recent years In terms of conformity evaluation of generic drugs, eight acceptance numbers have been reviewed, four of which have been approved for production, including captopril tablets, azithromycin tablets and tramadol hydrochloride tablets In terms of new drug application in China, dozens of drugs are under review, and many of them are included in the priority review, such as paclitaxel for injection (albumin binding type) approved recently The enterprise takes "innovation" and "internationalization" as two driving engines At present, 17 andas have been approved by FDA, including 8 in 2017 4 With the development of bioequivalence test, the clinical trial institutions, which are popular in clinical trials of conformity evaluation, are particularly nervous, and become the object of cooperation between cro company and pharmaceutical companies The figure below shows the top 10 most popular clinical trial institutions among the registered clinical trials of conformity assessment, and the most popular clinical center of Shanghai public health, with 55 registration numbers 5 According to the registration data of 289 catalog consistency evaluation clinical trials, 402 clinical trials belonging to 289 catalog were newly registered from 2016 to August 2018, accounting for 64.7% of the total 621 On the other hand, the number of drug varieties in 289 catalogue of 389 registration numbers is 94, accounting for about 1 / 3 of the total 289 Of course, CDE has released a part of 289 catalog varieties that can be exempted from bioequivalence test Simply list the most popular drugs registered in the 289 directory consistency evaluation clinical trials, and it can be seen that they are basically the same as the overall consistency clinical trials, that is to say, the drugs registered most in the clinical trials basically belong to the 289 directory In general, the consistency evaluation of generic drugs is undoubtedly the hottest topic in the industry in the past three years, and dissolution, be test and clinical effectiveness test are the key to the consistency evaluation The data of this paper comes from the database of Chinese clinical trials and the platform of registration and information publicity of drug clinical trials According to the Convention, Amway finally added new functions to the database of Chinese clinical trials: the database added stock code and consistency evaluation search box The former can retrieve all clinical trial information of the listed company and its subsidiaries by inputting the stock code or enterprise name of the listed company The latter can quickly screen out the clinical trials corresponding to the consistency evaluation of generic drugs At the same time, there are also consistency evaluation screening conditions in the secondary screening Isn't it convenient? Let's experience it quickly!
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