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    Home > Medical News > Medical World News > Accelerate the integration with ICH release of regional implementation guide for individual safety report e2b (R3)

    Accelerate the integration with ICH release of regional implementation guide for individual safety report e2b (R3)

    • Last Update: 2019-11-26
    • Source: Internet
    • Author: User
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    On November 22, 2019, each big circle of friends and network platform was swiped by a "Notice of the drug evaluation center of the State Food and Drug Administration on the implementation guide for e2b (R3) region of individual safety report", which showed us once again the determination and action of the State Food and Drug Administration to accelerate the integration with ICH This article combed the individual safety report specification (ICH) for you E2b (R3)) As a very important international organization in the field of drugs, the International Conference for the technical coordination of human drug registration (ICH) is mainly to coordinate the technical requirements of drug registration in various countries, so that drug manufacturers can apply unified registration data and improve the efficiency of new drug research and development, registration and marketing Individual safety report is one of the main sources of adverse drug reaction signals, such as In the absence of a unified standard, individual safety reports will be multifarious and disordered ICH has standardized the clinical safety data management rules ICH e2b in detail, with a view to guiding individual medical record safety reporting norms in different countries Since the National Drug Administration (nmpa) officially joined the International Conference for the technical coordination of human drug registration (ICH) in June 2017, and became the eighth member of the global regulatory body, the relevant notices and specifications of ICH e2b (R3) have been arranged and implemented in an orderly manner to ensure clinical safety to the greatest extent On November 22, 2019, the drug evaluation center of the State Food and Drug Administration issued the Q & a document of regional implementation guide for individual safety report e2b (R3), which is a supplement to the content of the implementation guide The common questions and interpretations are as follows: 2.1 in what form should serious overseas reports be reported? 2.2 how to fill in a case safety report? 2.3 how to evaluate the relevance? 2.4 how to configure? How to handle transmission exceptions? reference:
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