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    Home > Medical News > Medical World News > 263 medical registration applications were withdrawn and Roche and Abbott were named

    263 medical registration applications were withdrawn and Roche and Abbott were named

    • Last Update: 2021-02-21
    • Source: Internet
    • Author: User
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    According to incomplete statistics, since June 8, 2016, when the CFDA issued a notice on the implementation of clinical trial supervision and spot checks on medical devices, a total of 122 enterprises have withdrawn 263 medical device registration applications, and the situation of drug registration applications being voluntarily withdrawn after the July 22 clinical self-examination and verification has been repeated.
    December 16, 2016, the CFDA announced that 27 companies had withdrawn 32 medical device registration applications for the period from October 20, 2016 to December 12, 2016.
    not the first time the CFDA has released information about a company's initiative to withdraw a medical device registration application. It goes back to June 8, 2016, when the CFDA announced, in the form of a notice, that it would conduct a spot check on clinical trials conducted before June 1, 2016 in the form of a "regressive examination" of clinical trials conducted before June 1, 2016. The scope of spot checks includes all domestic third-class and imported medical devices in China through clinical trials to obtain clinical trial data registration applications.
    the first batch of inspections, focusing on June to October 2016, CFDA in phases formed inspection teams to carry out on-site inspections in accordance with the on-site inspection procedures for clinical trials of medical devices. From October to November, the second batch of medical device clinical trials was monitored and tested.
    From 2014 to 2016, from the introduction of a number of medical device-related laws and regulations, to various types of product registration technical guidelines have been introduced, to the provincial bureaus of device clinical trial verification intensive release, are showing the increasingly strict supervision of the quality of device clinical trials trend. The spot check is also another move by the National Bureau of Medicine in clinical trials of medical devices after the drug self-examination and verification.Medy machine sampling, Roche, Abbott recruitment
    from the results, medical equipment spot checks are quite effective, some companies "unfortunately" were sampled, the results did find problems, was named and criticized.
    December 16, 2016, the General Administration issued a notice informed of the authenticity of clinical trials of three medical device registration applications, including Anhui Tongke Biotech Co., Ltd., Roche Dignostics GmbH of Germany and LSIMedience Corporation of Japan. The reason for the investigation was that sample reuse was found in all three registered project clinical trials, and sample reuse was not involved in clinical trial scenarios, and the experimental report did not specify sample reuse.
    the result of the problem being found is naturally serious. According to the relevant regulations on the registration of medical devices, the registration application items with authenticity problems mentioned above shall not be registered and shall not be re-accepted within one year from the date of non-registration, and the clinical trial institutions involved and the relevant responsible requests for investigation and treatment by the provincial food and drug regulatory bureaus shall be made.
    is not the only well-known pharmaceutical company in China. In the first batch of medical device clinical trial supervision spot checks, the human T lymphocyte virus I./II. type anti-medical test kit (chemical luminescent particle immunotestion method) applied by The German AbbottGmbH-Co.KG was also found to be authentic and eventually received the same penalty.Active recall, has been involved in 100 enterprises
    According to E drug manager incomplete statistics, since June 8, 2016, the CFDA issued a notice on the implementation of medical device clinical trial supervision and spot checks, a total of 122 enterprises on 263 medical device registration applications were withdrawn, July 22 clinical self-examination and verification of large-scale drug registration applications were voluntarily withdrawn after the situation was repeated.
    according to information made public by the CFDA, 51 companies withdrew 101 applications for medical device registration between August 26 and October 19, and 44 companies withdrew 130 applications from August 26 to October 19. The latest withdrawals were made between 20 October and 12 December, when a total of 27 companies withdrew 32 applications.
    , the German company with the largest number of withdrawal applications was ORGENTEC Dignostika GmbH, which involved 12 receiving numbers and was made in kits. Previously, the enterprise's anti-soluble liver antigen antibody determination kit (enzyme immunology method) was pointed out that in the clinical trial conducted by Tianjin People's Hospital, serum samples were not used in accordance with the clinical trial plan, and can not be traced, so the application was not registered.
    the largest number of domestic enterprises withdrawing applications were Jiangsu Zecheng Biotechnology Co., Ltd. and Nantong Delnos Biotech Co., Ltd., with 18 and 28 respectively. In a notice of non-registration by the CFDA on October 17, 2016, a total of nine acceptance numbers were not registered by Nantong Delnos. (E drug manager)
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