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

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 …

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 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 …

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the …

Jun 25, 2025 · The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period.

Nov 13, 2024 · The ICH continues to expand and welcomed with great pleasure CPPS, Uzbekistan; DIGEMID, Peru and Thai FDA, Thailand as new ICH Observers, bringing ICH to a …

About ICH Mission History Transparency Funding ICH Award Work with ICH Organisational Chart Members & Observers Value of Membership Application Process Articles & Procedures Work …

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 …

The ICH Harmonised Guideline was finalised under Step 4 in November 1996. This document gives guidance on the format and content of safety updates, which need to be provided at …