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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All about medicines
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Funding, statistics and key operating information
News for media
Eleven medicines recommended for approval, including four orphans ... Read more
Brineura reviewed under accelerated assessment ... Read more
Revised guidelines to encourage development of veterinary medicines for minor uses and minor species
Guidelines clarify data needed for authorisation of medicines for treatment of minor-use-minor-species/ limited-market ... Read more
CVMP opinions on veterinary medicinal products ... Read more
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Events of interest
29/03/2017 - 30/03/2017
Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop
The European Union funds three projects, Asterix, IDeAl and InSPiRe, 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. The workshop will discuss their results to date. The aim 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 personalised 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
The tenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will discuss good pharmacovigilance practices, periodic safety update reports and registries. ... Read more
This SME info day provides an overview on the key features and objectives of the new clinical trial regulation. It also covers the future clinical trial authorisation process, the functionalities of the EU CT portal and database, transparency aspects of the new regulation and safety reporting requirements. The event is for companies that have been assigned SME status by the EMA and representatives of stakeholder organisations. ... Read more
16/03/2017 - 17/03/2017
The European Medicines Agency veterinary medicines info day, organised in collaboration with International Federation for Animal Health Europe (IFAH-Europe), provides first-hand information on the latest developments in the scientific review, regulation and marketing authorisation procedure in the field of veterinary medicine regulation. For the first time, this year, European Medicines Agency (EMA) will have dedicated information points on esubmissions, veterinary application submissions and veterinary medicines innovation. ... Read more
The European Medicines Agency (EMA) launched the PRIME (PRIority Medicines) scheme in March 2016. The scheme provides early and enhanced support to medicines that have the potential to address patients’ unmet needs. This meeting is organised by EMA to review the experience gained with PRIME one year after it was launched. The aim of the meeting is to receive feedback from users and potential users of the scheme, provide information on how the rules on eligibility have been applied and what types of support applicants have received so far and discuss practical examples that illustrate the benefits of PRIME and how it builds on the existing tools. ... Read more
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