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 [...]

Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing (January 2020) [Track version] Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations (December 2022) [...]

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

In order to allow applicants and MAHs to timely register in OMS, the deadline for mandatory use has been further extended and the mandatory use of OMS Organisation Management Service (OMS) for CAPs now starts on 1st of November 2021. Early registration of site(s)/organisations in OMS is encouraged.

Call for review for chemically synthesised and biological medicinal products Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities. The call for review was extended to biological active substances in July 2020, as an outcome of CHMP's Article 5(3) [...]

Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.

Further to the ICH Q13 draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH Q13 EWG has been finalised.

DADI project update is now available. This update includes a timeline for the first forms to be released, a list of features of the human variation form and an updated questions & answers document.

An updated release schedule for the electronic Application Forms (eAF) is now available. The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with a short 1-month transitional period and mandatory use from 1st of November 2021. The release v1.25.0.0 will provide a major change into [...]