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.

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.

Recommendations on submission dates in 2025 for Applications of the DCP (October 2024)Recommendations on submission dates in 2024 for Applications of the DCP (October 2023)

Template: Cover letter for new applications submitted through MRP/DCP (June 2024) [Track version]

Updated draft DES summary and draft XSD files for the Veterinary MAA and variation forms are now available on the eAF website.

CMDh Best Practice Guide on Multilingual Packaging (February 2024) [Tracked version]