LEGAL FRAMEWORK Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use (Variation Regulation) has entered into force on 7 July 2024. It became applicable on 1 January 2025. This regulation revised the rules setting [...]

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

Best Practice Guide for the exchange of regulatory and administrative information regarding orphan medicinal products between EMA and National Competent Authorities (October 2016, correction March 2024) [Track version]

Overview of timetables 2024 (September 2023)Overview of timetables 2025 (September 2024)

Following the adoption of the E11A Guideline, a Step 4 Introductory Training Presentation has been developed by the E11A Expert Working Group.

Loperamide, loperamide/simethiconeEnd of procedure: 25/05/2024Date of publication: 25/09/2024

Added in October 2024 3 October UPDATE - Article 30 Tracking table  1 October UPDATE - Contact Points

Labelling requirements for metered dose inhalers containing fluorinated greenhouse gases (September 2024)

The ICH E11A Guideline “Paediatric Extrapolation” reached Step 4 of the ICH Process on 21 August 2024.

The ICH is announcing that it will be releasing a Request for Information (RFI) expected in October to determine interest and potential approaches to support the ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force’s initial assessment for a secure standardised regulatory platform.