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    Home > Active Ingredient News > Drugs Articles > From international multi-center to global multi-region, from bridging to the whole, what are the key points of the E17 guiding principles related to the internationalization of all new drugs?

    From international multi-center to global multi-region, from bridging to the whole, what are the key points of the E17 guiding principles related to the internationalization of all new drugs?

    • Last Update: 2021-06-05
    • Source: Internet
    • Author: User
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    With the acceleration of the globalization of drug research and development, the clinical research and development model of new drugs has also changed.


    With the acceleration of the globalization of drug research and development, the clinical research and development model of new drugs has also changed.


    "In 2007, Article 44 of Chapter 3 of the "Administrative Measures for Drug Registration" (ie, the old regulations) clearly put forward the term'international multi-center clinical trials', and also proposed the application of international multi-center clinical trials in China.


    In the case analysis part, Wang Chaoyun shared with you the regional differences that have been found in the previous clinical trials and clinical practice of different types of drugs, and reminded that the implementation work group (IWG) of the ICH E17 guideline was finalized in 2017 and is also global The developers have written training materials, which can be downloaded from the ICH website.


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