Today, the Accelerating Clinical Trials in the EU (ACT EU) initiative, jointly run by the European Commission, European Medicines Agency and Heads of Medicines Agencies of the Member States, is publishing new draft guidance on the...
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...
Enpr-EMA’s annual meeting is a unique opportunity for networks and other stakeholders of paediatric clinical trials, such as health care professionals, parents, carers, patient representatives as well as medicine developers and regulators, to learn about...
The 2025 annual meeting of the members of the European network of paediatric research at the EMA (Enpr-EMA) and its Coordinating Group focused on recent Enpr-EMA developments, collaboration with ACT EU, and future strategic priorities....
Factsheet published by the European Commission on the key changes under the New Biotech Act: increased competitiveness for Europe on clinical trials, enhanced support in the development of innovative medicines, lower administrative and operational burden,...
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 need for guidance on the use of external controls was prioritised by the Methodology Working Party (MWP) in its consolidated 3-year workplan 2025-2027 and work has started on the development of a reflection paper...
EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats. Under the new process, developers of medicines falling within the...
The draft ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials was subject to a public consultation between June and September 2025. The Overview of the comments received from the consultation...
This annual meeting of the Multi-stakeholder platform (MSP), established as part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, features four key thematic sessions addressing innovations in patient-oriented research, methodology and biotechnology, AI and...
