Working with the media
Welcome to the European Medicines Agency’s online media centre. This page highlights information which is of specific interest to media professionals.
The page is kept updated with news, events and information for journalists with a professional interest in the development and availability of medicines in the European Union.
For more information, please contact the EMA press office.
Human medicines highlights for 2015
EMA has released an overview of its key recommendations in 2015 on the authorisation of new medicines and the safety monitoring of authorised medicines. EMA recommended 93 medicines for marketing authorisation. This includes recommendations for 39 new active substances.
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All about medicines
Search for information on medicines and browse the European database of suspected adverse drug reaction reports.
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Pharmacovigilance, inspections, falsified medicines
News for media professionals
Study is the main trial supporting use of Xarelto in atrial fibrillation ... Read more
Watch live broadcast of expert discussion at EMA ... Read more
Revised guideline is expected to facilitate development of more effective medicines ... Read more
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 2016
Six medicines, of which two have been fast-tracked, receive positive opinions from the Committee ... Read more
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Events of interest
04/02/2016 - 05/02/2016
Immunotherapy is becoming a fast growing area of new medicinal products in oncology. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice. Appropriate patient population selection, new clinical trials designs, rational for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of the key issues that we propose to address in a workshop organised with the Cancer Drug Development Forum (CDDF). The aim is to address these highly relevant issues and their impact on the regulatory environment. ... Read more
This workshop aims to help clarify the concept and demonstrate the significant benefit of new orphan medicines over existing treatments. It will discuss existing methodologies for comparative efficacy and effectiveness and for major contribution to patient care, including patient preferences, and how these could be applied in demonstrating significant benefit at marketing authorisation as well as the impact of significant benefit on health-technology-assessment (HTA) evaluation, pricing decisions and patient access. The workshop is targeted at medicine developers, regulators, healthcare professionals, academia, patients, HTA bodies and healthcare payers. ... Read more
Stakeholder meeting on product shortages due to manufacturing and quality problems: developing a proactive approach to prevention
In October 2013, a workshop held at the European Medicines Agency (EMA) led to the formation of an inter-industry association taskforce to propose possible solutions to the root causes of shortages due to manufacturing and quality problems. EMA is hosting a follow-up workshop on 9 October 2015 to discuss the solutions proposed by industry associations. Registration by invitation only. A live broadcast of the workshop will be available. ... Read more
First annual bilateral meeting between the European Medicines Agency and the European Generic and Biosimilar Medicines Association
This meeting between the European Medicines Agency (EMA) and the European Generic and Biosimilar Medicines Association (EGA) takes place in the context of EMA’s 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
European network of paediatric research-European Medicines Agency meeting on rare gastrointestinal and liver diseases
The European network of paediatric research (Enpr-EMA) is organising a one-day meeting. The morning session is dedicated to the Paediatric European Digestive Diseases Clinical Research Network (PEDDCReN) to present to industry representatives their planned initiative to prospectively identify the incidence and prevalence of rare and very rare diseases in the field of paediatric gastroenterology and hepatology by establishing a European registry for these rare diseases and to discuss with industry how best to use this to work for developing research in these unique groups of patients. The afternoon session is organised together with the European Cystic Fibrosis Society and will focus on gastrointestinal outcome measures for clinical trials with new medicines targeting the basic defect in cystic fibrosis, so-called CFTR modulators. ... Read more
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