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    Home > Active Ingredient News > Drugs Articles > Is self-examination of drug clinical trial data a double-edged strategy for CDE?

    Is self-examination of drug clinical trial data a double-edged strategy for CDE?

    • Last Update: 2015-07-23
    • Source: Internet
    • Author: User
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    Source: Xianda data / Jinglu 2015-07-23 introduction July 22, the State Food and Drug Administration issued the announcement on carrying out self inspection and verification of drug clinical trial data (2015 No 117), and the list of drug clinical trial data self inspection and verification varieties published 1622 acceptance numbers Xianda data v3.1 collates the acceptance numbers, 309 of which belong to 103 domestic listed companies On March 6, 2015, Sun Zhigang, deputy director of the national health and Family Planning Commission, expressed his opinion in the medical and health group of the CPPCC: "price is the only theory in drug bidding and purchase The quality is not the result of bidding, but of production, inspection and guarantee It is the responsibility of the drug administration " Since then, the drug administration has begun to improve the traditional Chinese medicine decoction pieces, Ginkgo biloba extract and biochemical drugs Flight inspection has become more and more common The news that GMP certificate has been cancelled can be seen in the industry news almost every day Now the drug administration has focused its work on the clinical trial data of drugs On July 22, the State Food and Drug Administration issued the announcement on the self inspection and verification of drug clinical trial data (No 117 in 2015) The list of drug clinical trial data self inspection and verification varieties published 1622 acceptance numbers, including 171 acceptance numbers for imports, 948 acceptance numbers for new drugs, and 503 acceptance numbers for national standards There are 1283 acceptance numbers for chemical drugs, accounting for 79.1% Most of the acceptance numbers of traditional Chinese medicine are from 2005 to 2006, a total of 237, accounting for 14.6% There are 102 acceptance numbers for biological products According to the monitoring of Xianda data v3.1 on the provinces, Jiangsu ranks first, 199 acceptance numbers need self-examination; followed by Shandong 136 acceptance numbers; Zhejiang ranks third, 120 acceptance numbers in total; Beijing 117 acceptance numbers rank fourth; Guangdong follows closely, 116 acceptance numbers in total; Shanghai ranks tenth with 47 acceptance numbers In terms of product generic name, 968 generic names are involved in this self-examination, among which amlodipine besylate tablets have the largest number of self-examination acceptance numbers, 19 in total; rosuvastatin calcium tablets have 17 self-examination acceptance numbers, ranking second; ornidazole tablets have 14 acceptance numbers, ranking third; Domperidone Tablets have 12 acceptance numbers, ranking third; lamivudine tablets and clopidogrel bisulfate tablets have 11 acceptance numbers respectively Four acceptance numbers are tied for the fourth place Dasatinib tablets, human immunoglobulin, faropenem sodium tablets, ornidazole tablets, palonosetron hydrochloride injection, amlodipine besylate tablets and cefotetan disodium for injection are the main products that need self-examination of domestic listed companies Each common name has four acceptance numbers and self-examination 309 of 1622 acceptance numbers belong to 103 listed companies in China Huahai pharmaceutical industry has the largest number of acceptance numbers (sh600521), including valsartan tablets, valsartan hydrochlorothiazide tablets, candesartan ester hydrochlorothiazide tablets, Telmisartan Tablets, levetiracetam tablets, migrainet calcium tablets, non Bustan tablets, escitalopram oxalate tablets and lamotrigine tablets If the number of drug names ranks first, Hengrui and Guoyao are the same, and each 14 product names need self-examination A total of 27 product names applying for class 1 or 1.1 need self-examination, 9 of which belong to listed companies, including p-toluenesulfonamide injection of Tianjin HongRi, repagliptin phosphate tablets and carbofloxacin hydrochloride glucose injection of Jiangsu Hengrui, astragaloside glucose injection of Guizhou Jingfeng, benalutide injection of Shanghai Renhui biology, etc Among the acceptance numbers that need self-examination, 13 belong to major special projects, and domestic listed companies account for 8 acceptance numbers 21 acceptance numbers belong to special channels, 11 of which are listed companies in China; there are 7 acceptance numbers of accelerated varieties to be self checked, one of which belongs to the domestic superior company The recombinant HPV (yeast) vaccine (6, 11, 16, 18) of MSD, which was not approved at one time, and the HPV adsorption vaccine of GSK are also in the list of this self-examination Similar products include Jingyuqinggan capsule, 13 kinds of multivitamin injection solutions and bailing tablets 102 acceptance numbers once in the status of "approved production" also face self-examination 11 acceptance numbers belong to domestic listed enterprises Summary in order to implement the four strictest requirements of "the strictest standards, the strictest supervision, the strictest punishment, the strictest accountability, and to ensure the safety of food and drug use of the people" of the Party Central Committee and the State Council, the drug regulatory bureau began to carry out the data verification of drug clinical trials for the registered application of drugs that have been declared for production or import If the applicant finds that the clinical trial data are untrue and incomplete through self inspection, he can apply to the State Food and Drug Administration for withdrawal of registration before August 25, 2015 "In the process of drug evaluation, if it is found that the applicant has any of the following circumstances, the registration application shall not be approved in accordance with the relevant provisions of Article 154 of the measures for the administration of drug registration Including: (1) refusing, evading or hindering the examination or destroying evidence; (2) the clinical trial data cannot be traced and the data are incomplete; (3) the authenticity is questionable without reasonable explanation and evidence; (4) the self-examination report has not been submitted For the applicants found in the verification that there are problems in the authenticity of clinical trial data, their applications will not be accepted within 3 years The State Food and Drug Administration will organize experts to analyze the data of the applicant's self inspection materials and carry out flight inspection as the case may be If it is found during the inspection that the clinical trial data are falsified, and the clinical trial data are incomplete and untrue, the applicant, clinical trial institution and contract research organization shall be investigated for their responsibilities in accordance with Article 78 of the drug administration law of the people's Republic of China and article 166 of the measures for the administration of drug registration, and the applicant and clinical trial institution shall be made public The contract research organization, its legal representative and relevant responsible personnel " Of the 1622 acceptance numbers, many were before 2008 CDE once promised to solve the problem of overstock of drug declaration within three years, but at present, its processing capacity is limited, which is far less than the enthusiasm of drug companies in declaring products According to the current high requirements for clinical data to self check the clinical projects declared before 2008, there are few projects that can meet the existing standards If the enterprise does not voluntarily withdraw the registration application, most of the historical data of the project are incomplete, and it is not realistic to redo it now According to the regulations, if the data is incomplete, it will also be punished After the game, the product enterprises that fail to pass the project data can only choose to retreat Through the self inspection of clinical data, drug companies retreated in spite of difficulties By the way, a large number of issues of backlog of acceptance numbers were also solved This move by the drug regulatory bureau can be described as a double shot As for enterprises, only those enterprises with long-term high standard requirements can cope with increasingly strict laws and regulations It is difficult to fish in troubled waters for those who have muddled along in the past.
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