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]

ICH is pleased to announce the publication of a 30th Anniversary document. This follows ICH’s 2020 celebration of 30 years of harmonisation activity.

The ICH Secretariat is pleased to announce that following the conclusion of the ICH E6(R3) EWG’s Public Web Conference on Good Clinical Practice in May 2021, a Report is available to download and a Video Presentation has been published on the ICH YouTube channel.

An updated version of the Questions and Answers document to support applicants and Marketing Authorisation holders in the implementation of the mandatory use of OMS for CAPs can be found. Please note that a training webinar on OMS will be held on 21st of October 2021, where registered participants will have the opportunity to clarify [...]

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The use of Organisational Maintenance Services (OMS) will become mandatory for Centrally Authorised Products (CAPs) from 1st of November 2021.

This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.