In the second quarter of 2026, the European Medicines Agency will launch a pilot programme to support breakthrough medical devices and in vitro diagnostics. The aim is to test a pathway that accelerates patient access...
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European Commission, European Medicines Agency and Heads of Medicines Agencies of the Member States, is publishing new draft guidance on the...
The European Medicines Agency (EMA) is hosting a workshop on supporting innovation in cardiovascular medicines and medical devices in the EU. This multi-stakeholder workshop will cover interdisciplinary discussions addressing a range of important topics including...
This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 6, Manufacture of Medicinal Gases, of the Good Manufacturing Practice (GMP) guide, that is common to the...
This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 15, Qualification and validation, of the Good Manufacturing Practice (GMP) guide, that is common to the Member...
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Ojemda (tovorafenib) to treat patients aged 6 months and older with paediatric low-grade glioma (a type of brain tumour). Ojemda can...
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)...
EMA has recommended extending the therapeutic indication of Zynyz (retifanlimab) to include treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally...
EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle. The principles give broad guidance on AI use in evidence generation...
