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.
The ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH process on 6 October 2021 and now enters the public consultation period.
New version 1.25.0.0 of all four eAFs is now available for immediate use. The main changes in this version of the forms relate to the implementation of the Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745 and include other changes as implemented in the latest version of the NTA application forms.
Paediatric Regulation [Track version] (June 2023) Further Q&As have been published on the EMA website
List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation (May 2023)
Paediatric Regulation: Article 45 and Article 46 Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (June 2023) [Track version]