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  • ICH Official web site : ICH
    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines
  • ICH Official web site : ICH
    ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years
  • ICH Official web site : ICH
    The ICH Harmonised Guideline was finalised under Step 4 in February 2002 This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline
  • ICH Official web site : ICH
    You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary
  • ICH Official web site : ICH
    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration
  • ICH Official web site : ICH
    The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law
  • Welcome to the ICH Official Website | ICH
    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines
  • ICH Official web site : ICH
    ICH Award Work with ICH Organisational Chart Members Observers Value of Membership Application Process Articles Procedures Work Plans Reports Work Products Process of Harmonisation Public Consultations Guideline Implementation All Guidelines Quality Guidelines Safety Guidelines Efficacy Guidelines Multidisciplinary Guidelines Index of
  • ICH Official web site : ICH
    In order to facilitate the implementation of the CTD General (M4) Guideline, the ICH Experts have developed a series of Q As The document which reached Step 4 of the ICH Process in June 2004, intends to clarify the key issues regarding the CTD
  • ICH Official web site : ICH
    The ICH Harmonised Guideline was finalised under Step 4 in November 2003 This document provides a standardised procedure for post-approval safety data management and the guidance for gathering and reporting information





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