Transcription of ORGANISATION OF THE COMMON TECHNICAL D …
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ORGANISATION OF THE COMMON TECHNICAL D …
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE ORGANISATION OF THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE M4 Current Step 4 version dated June 15, 2016 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, USA, Canada and Switzerland.
international council for harmonisation of technical requirements for pharmaceuticals for human use ich harmonised guideline organisation of the common technical document for the
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