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.
For enquiries from media, please contact the EMA press office.
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.
Search for all press releases, news items and other media materials.
All about medicines
Search for information on medicines and browse the European database of suspected adverse drug reaction reports.
Find out more about EMA's scientific committees and working parties
Funding, statistics and key operating information
News for media
Six medicines recommended for approval, including three orphans ... Read more
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Medicines where suitable alternative data are available can remain on market ... Read more
EU vaccine composition advice is based on WHO recommendations ... Read more
Task force to establish roadmap and recommendations for use of big data in assessment of medicines ... Read more
EMA to set up technical group in the context of the publication of clinical data ... Read more
- See all News for media
Events of interest
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
Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines
The European Medicines Agency (EMA) held a public consultation a concept paper which outlined the major areas for revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’, from July to September 2016. Subsequently, EMA published a draft revised guideline for public consultation, from November 2016 to February 2017. This technical workshop aims to finalise the guidance with further involvement of stakeholders including from other regulatory agencies, pharmaceutical industry, contract research organisations and academia. The focus of the workshop will be on discussing comments received during the public consultations, therefore participation of external stakeholders is limited to those individuals and organisations who submitted comments. The output of the workshop will be reflected in the final revised guideline and the published overview of comments. ... Read more
First 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
The Enpr-EMA coordinating group contributes to the short and long-term strategy of the network, discusses and solves operational and scientific issues for the network, reports to the Paediatric Committee, which acts as the scientific committee of Enpr-EMA, and acts as a forum for communication. The group meets three times every year. ... Read more
This information day will provide an update on essential signal detection and management activities in the European Union (EU) for the overall surveillance and risk management of medicines. It will explore the final guidance provided following the finalisation of the good pharmacovigilance practices module IX on signal management and related aspects of the EU pharmacovigilance legislation. It will also cover marketing authorisation holders’ access to EudraVigilance and the resources and training the Agency provides to support stakeholders. Finally, it will discuss stakeholders’ approaches and perspectives on signal management. ... Read more
- See all Events of interest