The Council for International Organizations of Medical Sciences (CIOMS) has published Version 10 of its Glossary of ICH Terms and Definitions, consolidating terminology from current ICH guidelines and supporting greater consistency in regulatory communication across the life sciences sector.

ICH has adopted E6(R3) Annex 2, introducing new Good Clinical Practice guidance for decentralised clinical trials, digital health technologies and real-world data. Learn what it means for medical device manufacturers.

The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.