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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]

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (October 2023) (If you experience any difficulties to open the documents, please check the local security options in your local system/PC and/or within your browser (see also the browser option "open with") The update of the CMDh List of safety concerns [...]

Examples for acceptable and not acceptable groupings for MRP/DCP products (October 2025) [Track version]