Variations [Track version] (December 2023)

Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP  (January 2024) [Track version]

QP declaration [Track version] (February 2025) 

ICH is pleased to announce the publication of a Leaflet on ICH.

An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available. The updated guidance enters into force 1st February 2022.

Meeting 14-16 December 2021: Agenda - MinutesMeeting 09-11 November 2021: Agenda - MinutesMeeting 12-14 October 2021: Agenda - MinutesMeeting 14-16 September 2021: Agenda - MinutesMeeting 20-22 July 2021: Agenda - MinutesMeeting 22-23 June 2021: Agenda - Minutes - Correction 25/08/21Meeting 18-20 May 2021: Agenda - MinutesMeeting 20-22 April 2021: Agenda - MinutesMeeting 23-25 March 2021: Agenda - MinutesMeeting 23-24 February 2021: Agenda - Minute - Update 07/10/2021Meeting 26-27 January 2021: Agenda - Minutes

National recommendations for requests to act as RMS  (March 2024)

The Digital Application Dataset Integration (DADI) Network Project to replace electronic application forms is pleased to announce it's first public webinars which will take place on 18 January 2022, h. 10:30-12:00 Central European Time (CET) and on 25 January 2022, h. 10:30-12:00 Central European Time (CET).

New version 1.26.0.0 of all eAFs is now available on the eAF website. The forms for human applications (maa, variation and renewal) are ready for immediate use. The use of the v1.26.0.0 for human procedures becomes mandatory after a short one-month transitional period on 1st January 2022. The version v1.25.0.0 of the human forms has [...]

The International Council for Harmonisation (ICH) met virtually on 17 and 18 November. The Assembly meeting was preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.