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.
The ICH M13A Guideline and associated Q&As on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” reached Step 4 of the ICH Process on 23 July 2024.
Added in August 2024 2 August UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers