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...
Building on the previous work of the Big Data Steering Group over the last 5 years, this annual event – coordinated by the Network Data Steering Group – offers an opportunity to engage with regulators...
This joint hybrid HMA/EMA workshop on Patient Registries followed on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of Patient Registries held in 2024. The...
