EMA launched a voluntary data submission pilot to facilitate sharing of data generated using New Approach Methodologies as alternatives to animal testing.
EMA - European Medicines Agency · EU-wideThe Accelerating Clinical Trials in the EU advice pilot, coordinated by HMA, becomes a permanent initiative from January 2027 to support sponsors in preparing clinical trial applications.
EMA - European Medicines Agency · EU-wide24 Sep 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – September 2026 Online Start date: 24 September 2026, 09:30 (CEST) End date: 24 September 2026, 10:30 (CEST)
EMA - European Medicines Agency · EU-wide19 Oct 2026 Clinical Trials Information System (CTIS) sponsor end user training programme - October 2026 Online European Medicines Agency, Amsterdam, the Netherlands Start date: 19 October 2026, 09:00 (CEST) End date:...
EMA - European Medicines Agency · EU-wideNewThis Walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical information about the Clinical Trials Information System by asking CTIS experts questions in advance.
EMA - European Medicines Agency · EU-wide10 Sep 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – September 2026 Online Start date: 10 September 2026, 09:30 (CEST) End date: 10 September 2026, 10:30 (CEST)
EMA - European Medicines Agency · EU-wide23 Jul 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026 Online Start date: 23 July 2026, 09:30 (CEST) End date: 23 July 2026, 10:30 (CEST)
EMA - European Medicines Agency · EU-wide12 Oct 2026 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system European Medicines Agency, Amsterdam, the Netherlands Start date: 12 Oc...
EMA - European Medicines Agency · EU-wide23 Sep 2026 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September 2026 Online Start date: 23 September 2026, 09:00 (CEST) End date: 25 September 2026, 13:30 (CEST)
EMA - European Medicines Agency · EU-wideEMA advises marketing authorisation holders on submission deadlines for type I variations to receive outcomes in 2026.
EMA - European Medicines Agency · EU-wide07 Oct 2026 Committee for Advanced Therapies (CAT): 7-9 October 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 7 October 2026 End date: 9 October 2026
EMA - European Medicines Agency · EU-wide20 Oct 2026 21st industry stakeholder platform - operation of European Union (EU) pharmacovigilance Online European Medicines Agency, Amsterdam, the Netherlands Start date: 20 October 2026, 13:00 (CEST) End date: 20 O...
EMA - European Medicines Agency · EU-wide07 Oct 2026 Q&A clinic on Substance, Organisation, Referentials Management Services - October 2026 Online Start date: 7 October 2026, 15:30 (CEST) End date: 7 October 2026, 16:00 (CEST)
EMA - European Medicines Agency · EU-wide28 Sep 2026 Pharmacovigilance Risk Assessment Committee (PRAC): 28 September - 1 October 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 28 September 2026 End date: 1 October 2026
EMA - European Medicines Agency · EU-wideThe Industry Standing Group (ISG) is a forum for interaction that has been established as part of the EMA's continuous improvement for engagement with industry stakeholders supply chain of human, veterinary and medica...
EMA - European Medicines Agency · EU-wideEMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today, EMA’s Executive Director Emer Cooke and...
EMA - European Medicines Agency · EU-wide13 Oct 2026 Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party European Medicines Agency, Amsterdam, the Netherlands Start date: 13 October 2026 End date: 14 October 2026
EMA - European Medicines Agency · EU-wide13 Oct 2026 Paediatric Committee (PDCO): 13-16 October 2026 Online European Medicines Agency, Amsterdam, the Netherlands Start date: 13 October 2026 End date: 16 October 2026
EMA - European Medicines Agency · EU-wideInformation session for veterinary students on pharmacovigilance.
EMA - European Medicines Agency · EU-wideThe Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.
EMA - European Medicines Agency · EU-wideThe Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.
EMA - European Medicines Agency · EU-wide23 Sep 2026 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2026 Online European Medicines Agency, Amsterdam, the Netherlands Start date: 23 September 2026, 10:...
EMA - European Medicines Agency · EU-wide22 Sep 2026 Committee for Herbal Medicinal Products (HMPC): 22-24 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 22 September 2026 End date: 24 September 2026
EMA - European Medicines Agency · EU-wide20 Oct 2026 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations Online European Medicines Agency, Amsterdam, th...
EMA - European Medicines Agency · EU-wide30 Sep 2026 Management Board meeting: 30 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 30 September 2026 End date: 30 September 2026
EMA - European Medicines Agency · EU-wide14 Sep 2026 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system European Medicines Agency, Amsterdam, the Netherlands Start date: 14 Se...
EMA - European Medicines Agency · EU-wide09 Sep 2026 Q&A clinic on Substance, Organisation, Referentials Management Services - September 2026 Online Start date: 9 September 2026, 15:30 (CEST) End date: 9 September 2026, 16:00 (CEST)
EMA - European Medicines Agency · EU-wide09 Sep 2026 Committee for Advanced Therapies (CAT): 9-11 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 9 September 2026 End date: 11 September 2026
EMA - European Medicines Agency · EU-wide17 Sep 2026 Quarterly System Demo - Q3 2026 Online European Medicines Agency, Amsterdam, the Netherlands Live broadcast Start date: 17 September 2026, 09:00 (CEST) End date: 17 September 2026, 11:30 (CEST)
EMA - European Medicines Agency · EU-wideDiscover how EMA is advancing women’s health in medicines development and regulation Developers can submit New Approach Methodologies data and receive tailored feedback Evidence based information addressing concerns, ...
EMA - European Medicines Agency · EU-wideThe ninth EMA-EFPIA bilateral meeting is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations.
EMA - European Medicines Agency · EU-wide15 Sep 2026 Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party Online Start date: 15 September 2026, 09:30 (CEST) End date: 15 September 2026, 13:00 (CEST)
EMA - European Medicines Agency · EU-wide14 Sep 2026 Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 14 September 2026 End date: 17 September 2026
EMA - European Medicines Agency · EU-wideThe fifth EMA and Affordable Medicines Europe bilateral meeting is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations.
EMA - European Medicines Agency · EU-wide17 Aug 2026 Committee for Medicinal Products for Human Use (CHMP): 17-20 August 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 17 August 2026 End date: 20 August 2026
EMA - European Medicines Agency · EU-wide12 Aug 2026 Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party Online Start date: 12 August 2026, 09:30 (CEST) End date: 12 August 2026, 13:00 (CEST)
EMA - European Medicines Agency · EU-wideBrussels, 14 July 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Dear Ms Jerkovic, dear…
EMA - European Medicines Agency · EU-wideEMA warns of serious health risks from illegal GLP-1 receptor agonist medicines marketed for weight loss and diabetes.
EMA - European Medicines Agency · EU-wide05 Oct 2026 First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting Online European Medicines Agency, Amsterdam, the Netherlands Start date: 5 October 2026, 15:...
EMA - European Medicines Agency · EU-widePRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata Desogestrel- and etonogestrel-…, Agenda Agenda of the PRAC meeting 6-9 Jul...
EMA - European Medicines Agency · EU-wideReview will assess risk of leukoencephalopathy, a condition affecting the brainEMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in…, Agenda Agenda of the...
EMA - European Medicines Agency · EU-wideEmer Cooke spoke about reimagining the future of medicines regulation as part of the Sir Alasdair Breckenridge Lecture Series
EMA - European Medicines Agency · EU-wideFeatured information for European Academics and researchers in the field of medicine development.
EMA - European Medicines Agency · EU-wide31 Aug 2026 Pharmacovigilance Risk Assessment Committee (PRAC): 31 August - 3 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 31 August 2026 End date: 3 September 2026
EMA - European Medicines Agency · EU-wideOur Medicine finder above helps you find information on medicines authorised for human or veterinary use. You can find these by including the medicine's name or its active substance. It shows you information on centra...
EMA - European Medicines Agency · EU-wideEMA announces a regulatory roadmap by end of 2026 to improve consideration of women's health in medicines development and regulation.
EMA - European Medicines Agency · EU-wideEMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…
EMA - European Medicines Agency · EU-wideReview will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agen...
EMA - European Medicines Agency · EU-wideAt its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 Septem...
EMA - European Medicines Agency · EU-wideThe first meeting organised with APIC in the context of in the context of EMA's annual bilateral meetings with industry stakeholder organisations.
EMA - European Medicines Agency · EU-wide