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

It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

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 …

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.

The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing …

Jan 14, 2025 · The ICH E6 (R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by …

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 …

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 …

CTD brings together all Quality, Safety and Efficacy information in a common, harmonised format, accepted by regulators in all ICH regions. It has revolutionised regulatory review processes for …

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