Information for you
On this page, we highlight information of partcular relevance for media, including news, events and featured information for journalists with a professional interest in the development and availability of medicines in the European Union.
For more information and details relevant for media, see our News & events section.
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Human medicines highlights for 2016
EMA has released an overview of its key recommendations in 2016 on the authorisation of new medicines. EMA recommended 81 medicines for marketing authorisation. This includes recommendations for 27 new active substances.
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News for media
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017
Six medicines recommended for approval, including one orphan ... Read more
Orphan medicine Natpar recommended by CHMP for conditional marketing authorisation ... Read more
SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information
Diabetes patients reminded of importance of preventative foot care. ... Read more
Cytopoint treats dogs against atopic dermatitis ... Read more
CVMP opinions on veterinary medicinal products ... Read more
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Events of interest
This information day will provide an update of the key elements related to the signal detection and management activities in the EU essential to the overall surveillance and risk management process of a medicinal product. We will explore the final guidance provided upon finalisation the good vigilance practice Module IX on Signal Management where the different aspects of the EU pharmacovigilance legislation on the topic will be covered. We will also drill down to the EudraVigilance access by marketing authorisation holders and the tools and training provided by the EMA to support the stakeholders. The approaches and perspectives from the different stakeholders involved in the signal management process will be also explored and discussed. ... Read more
European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting
This meeting between European Medicines Agency (EMA) and the Association of the European Self-Medication Industry (AESGP) is being organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and promote dialogue on topics of common interest. ... Read more
The ninth annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) aims to bring relevant stakeholders together to discuss requirements, barriers and opportunities for high-quality clinical studies in children. Among the highlights of this year’s workshop are the recent efforts to increase cooperation between the European Union and the United States to facilitate global paediatric trials and medicine developments. ... Read more
29/03/2017 - 30/03/2017
Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop
Three projects, Asterix, IDeAl and InSPiRe, are funded by the EU within the Seventh Framework Programme (FP7)to develop new methodology on design and analysis of small population clinical trials since 2013. The projects are in their final phase, and are ready to discuss their results to date. The aim of the workshop is to translate and promote results and novel methodologies into tangible recommendations to advance the clinical research and development of medicines and new treatments for patients with a rare disease and personalized medicine. The results to date and draft recommendations for application will be discussed by international representatives of patient organisations, pharmaceutical industry, academic statisticians and clinical trial methodologists, clinical researchers, pharmaceutical industry and regulators. ... Read more
European Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs
The fifth annual regulatory conference organised by European Biopharmaceutical Enterprises (EBE), with the collaboration of the European Medicines Agency (EMA), will discuss initiatives to improve advanced therapy medicinal products (ATMPs) access to patients, specific requirements for gene-therapy medicinal products, meeting specific standards for development and commercialisation of ATMPs and listening to the stakeholders of innovative medicines. It will bring together speakers and panellists from a broad range of public and private stakeholders, including patients, academia, regulators, investors and industry. ... Read more
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