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 [...]
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) [...]