ICH announces organisational changes

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

On its inaugural meeting on 23 October 2015 the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH),  announced organisational changes:

ICH emphasizes that it is a truly global initiative and more involvement of regulators around the world is welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland. This is aligned with the possibility of wider inclusion of global industry sectors affected by ICH Harmonisation.

In addition, a more stable operating structure is achieved through the establishment of an ICH association, a legal entity under Swiss law,  which will facilitate future growth through the participation of new members. 

For further information please visit the ICH official website.