EMA Updates
The latest guidances, approvals, and safety alerts from EMA, curated by automated regulatory intelligence.
Mandates ISO/ICH E2B(R3) formats for individual case safety reporting (ICSRs) in the EU, effective since 30 June 2022, and drives operational readiness through…
Facilitates an EMA bilateral dialogue with the ISCT to exchange views on topics of common interest, with a focus on how industry and regulators coordinate on…
Provides an EMA Q&A clinic format for companies to ask questions about the XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) service, with monthly…
Clarifies how the EMA Product Management Service (PMS) makes data available through the Product User Interface (PUI) and the PMS API for centrally authorised…
Provides a public update on the EMA’s SPOR (Substance, Product, Organisation, Referentials) and XEVMPD services, focusing on recent achievements and planned…
CTIS Walk-in clinic (Oct 7, 2026) provides sponsor organisations practical Q&A on CTIS system functionalities, with questions about the interpretation of the…
Provides an EMA regulatory data management Q&A session covering Substance, Organisation, Referentials (SPOR) management services, including how EMA’s services…
Committee for Advanced Therapies (CAT) is scheduled to convene 7–9 October 2026 at the European Medicines Agency in Amsterdam to support the EU’s assessment…
COMP scheduled meeting (6–8 October 2026) will review applications for orphan medicinal product designation for medicines intended for diagnosis, prevention…
CVMP is scheduled to meet on 6–8 October 2026 to prepare the European Medicines Agency’s opinions on veterinary medicines-related questions.
Establishes the agenda context for the EMA Management Board meeting on 30 September 2026, reaffirming its supervisory responsibilities for budgetary and…
Organizes an EMA/EMRN multistakeholder workshop to identify evidence gaps and practical actions to strengthen women’s health research and regulatory…
Sets the agenda window for the EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting held 28 September–1 October 2026 to assess and steer human…
Promotes structured collaboration to address gaps in real-world data (RWD) collection for Duchenne muscular dystrophy, with the goal of generating meaningful…
Joint FDA/EMA workshop on herbal medicinal and botanical drug product development, which may shape how sponsors design CMC, clinical evidence, and safety…
Sets out EMA CHMP/HAEMWP clinical development expectations for medicines targeting sickle cell disease, including how to design confirmatory efficacy studies…
Sets out EMA CHMP clinical evidence expectations for medicines for thalassaemia, including how confirmatory efficacy/safety studies should be designed, what…
Provides an EMA PMS Q&A session focused on expectations for Product User Interface (PUI) and Application Programming Interface (API) considerations in the…
Provides training on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) processes and expectations, which may help sponsors and marketing…
Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…