For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific …

This document provides detailed guidance on the quality information to be included in module 2 and module 3 of the common technical document. Keywords: Common technical document …

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.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in …

Jan 31, 2017 · This document provides detailed guidance on the information to be included in the clinical overview sections of the common technical document. Keywords: Common technical …

The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review …

Dec 11, 2024 · This ICH guidance provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant …

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical …

Guidance on the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products). Keywords: Common …

The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory …