European Medicines Agency

The European Medicines Agency (EMA) was introduced in 1995, and is a decentralised agency of the European Union (EU), located in London. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.


News and press releases: Modernising the orphan designation process

19/06/2018 Modernising the orphan designation process EMA launches new submission portal today The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications. The portal, named ‘Iris’, provides a single space where applicants can submit and manage the information and documents related to their applications […]


News and press releases: Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

19/06/2018 Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU Publication of updated Q+As and practical guidance The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to […]


News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018

15/06/2018 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018 PRAC held public hearing on quinolone and fluoroquinolone antibiotics At its June meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed two ongoing safety reviews, as shown in the published agenda. As part of […]


News and press releases: Changes to submission and assessment of maximum residue limits of veterinary medicines in foods

07/06/2018 Changes to submission and assessment of maximum residue limits of veterinary medicines in foods Three new implementing regulations replace current guidance A set of three implementing measures will help strengthen the assessment of maximum residue limits (MRLs) of veterinary medicines in food-producing animals. They will also serve as key […]


News and press releases: Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience

07/06/2018 Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience Agenda and list of speakers for 13 June hearing available The European Medicines Agency (EMA) has published today the agenda and the list of speakers for its public hearing taking place on 13 June […]


News and press releases: Towards improved safety monitoring of veterinary medicines

06/06/2018 Towards improved safety monitoring of veterinary medicines Companies are encouraged to report all suspected side effects in EudraVigilance Veterinary The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted the first revision of its recommendation for the basic surveillance of medicines for animals in EudraVigilance […]


News and press releases: Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

01/06/2018 Two more EU Member States benefit from EU-US mutual recognition agreement for inspections Agreement now operational between 14 EU Member States and FDA The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made […]


News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

01/06/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018 Nine medicines recommended for approval, including two orphans The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines1, at its May 2018 […]


News and press releases: First monoclonal antibody therapy for prevention of migraine

01/06/2018 First monoclonal antibody therapy for prevention of migraine Aimovig recommended for marketing authorisation The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Aimovig (erenumab), the first human monoclonal antibody therapy for prevention of migraine. Aimovig belongs to a […]


News and press releases: New medicine for hereditary rare disease

01/06/2018 New medicine for hereditary rare disease Tegsedi addresses unmet medical need for treatment of hereditary transthyretin amyloidosis The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Tegsedi (inotersen), a medicine for treatment of […]


News and press releases: EMA restricts use of Keytruda and Tecentriq in bladder cancer

01/06/2018 EMA restricts use of Keytruda and Tecentriq in bladder cancer Data show lower survival in some patients with low levels of cancer protein PD-L1 Early data from two clinical trials1 show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of […]


News and press releases: Construction of new EMA building in Amsterdam on track

29/05/2018 Construction of new EMA building in Amsterdam on track Foundation stone-laying ceremony takes place at Zuidas                            The laying of the foundation stone for the European Medicines Agency’s (EMA) new building in the Zuidas area of Amsterdam was marked with a ceremony on Monday, 28 May 2018. Speaking to representatives […]


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

28/05/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018 New vaccine to reduce the incidence of intramammary infections in cows/heifers recommended for approval CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Ubac, […]


News and press releases: Development of antibiotics for children – towards a global approach

24/05/2018 Development of antibiotics for children – towards a global approach Workshop with regulators from EU, Japan and US open for registration The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss […]


News and press releases: Working together for people with rare and complex diseases

22/05/2018 Working together for people with rare and complex diseases Live broadcast of workshop with European Reference Networks on 29 May The European Medicines Agency (EMA), together with together with RD-ACTION (the European Joint Action for Rare Diseases) and the European Commission’s Directorate General for Health and Food Safety (DG SANTE), is […]