What is the M4 organization?
M4: Organisation
The document primarily addresses the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products).What is M4 in ICH?
ICH guideline M4 (R4) on common technical document. (CTD) for the registration of pharmaceuticals for human. use - organisation of CTD.
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on November 8, 2000, this guideline is recommended for adoption to the three regulatory parties to ICH.What is the module 4 of the CTD?
Module 4 Non-clinical study reports
Although it is recognised that the non-clinical data help to address the safety of the product, there are non-clinical studies (primary, secondary pharmacology stating the effects of the active substance on the different organs showing or not showing the intended efficacy.- The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond.
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