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).

May 11, 2022 · Guideline Training: • ICH is working to ensure that high quality training is available based upon scientific and regulatory principles outlined in its guidelines.

May 27, 2025 · The International Council for Harmonisation (ICH) guidelines are the global gold standard for clinical trial conduct, ensuring ethical integrity, data reliability, and patient safety.

Apr 4, 2024 · Following the UK’s exit from the EU, MHRA became a full Member of ICH in May 2022. This page serves as a directory for current ICH Guidelines which have been implemented by the …

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

Dec 4, 2025 · The U.S. Food and Drug Administration (FDA) has officially adopted the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidance 1. This long …

2 days ago · This harmonised guideline outlines general considerations about the use, design, conduct, analysis, and submission of PPS aimed at informing drug development, regulatory submission and …

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.

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 ICH regions …

3 days ago · Japan is taking a major step toward global regulatory harmonization with its newly released guidance on applying ICH (International Council for Harmonisation) guidelines to generic …