Following a public consultation carried out from 30 June 2025 to 30 November 2025, the EMA recently published the overview of comments on the ICH E20 guideline on adaptive designs for clinical trials. This document...
This guideline defines an harmonised framework for evaluating MIDD evidence and provides recommendations for related planning and regulatory interactions, implementation, reporting, and submission. In the rapidly evolving landscape of drug development, model-informed drug development (MIDD)...
This concept paper proposes to update Annex 3, Manufacture of Radiopharmaceuticals, of the Good Manufacturing Practice (GMP) guide. Annex 3 is common to the Member States of the European Union (EU)/European Economic Area (EEA) as...
Patient preference studies (PPS) aim to assess the relative desirability or acceptability of actual or potential health interventions, or their characteristics and outcomes. PPS can generate structured insights about the relative importance of characteristics, also...
The EMA recently issued a Draft guideline on quality of radiopharmaceuticals. This is meant to be the second revision of the guideline. The Draft guideline is currently under public consultation. The deadline for comments is...
The EMA recently issued a Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease. The latest revision of the guideline dates from...
This guideline provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation. The guideline provides general guidance on stability testing for type IA and...
This document provides guidance on the planning, conduct, analysis and interpretation of non-inferiority and equivalence comparisons in clinical trials. It replaces the ‘Guideline on the choice of the non-inferiority margin’ (EMEA/CPMP/EWP/2158/99) and ‘Points to consider...
The scope of the new and updated documents is the following: 1) Recommendations on criteria regarding the selection of a reporting Member State; 2) Recommendation paper on decentralised elements in clinical trials; 3) Recommendation paper...
The organisations representing stakeholders involved in GMP activities are encouraged to take part in the consultation and to receive all the comments of this consultation from their members, to compile and send the comments via...
