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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.
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News for media professionals
EMA Management Board and Heads of Medicines Agencies endorse EU Telematics Strategy and Implementation Roadmap 2015-2017 ... Read more
Summaries to help people make informed choices when taking herbal medicines ... Read more
Expressions of interest to represent civil society at PRAC and CAT to be submitted to European Commission by 30 September 2015 ... Read more
12-month pilot will support design of high-quality safety studies ... Read more
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Events of interest
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
The primary rationale for extrapolation is to avoid unnecessary studies in the target population for ethical reasons, for efficiency, and to allocate resources to areas where studies are most needed. In situations where the feasibility of studies is restricted, extrapolation principles may be applied for rational interpretation of the limited evidence in the target population in the context of data from other sources. As per the published European Medicines Agency (EMA) concept paper on extrapolation of efficacy and safety in medicine development, EMA is developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. With the aim of developing the regulatory framework the Agency is holding an EMA experts workshop on 30 September. This workshop aims to bring together experts from the European medicines regulatory network. Registration by invitation only. ... Read more
The European Medicines Agency (EMA) is hosting the first meeting of a new industry stakeholder platform on paediatric procedures. This is the first in a series of upcoming annual meetings between regulators and representatives of industry stakeholder organisations. It aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The first meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the class waiver list review, the early interaction process, public summaries and paediatric investigation plan (PIP) compliance check during validation. Registration closed. ... Read more
01/10/2015 - 02/10/2015
Nearing a decade of the European Union (EU) Paediatric Regulation, with close to 2,000 submitted paediatric investigation plans, paediatric needs are recognised as an integrated part of drug development with the inclusion of children now accepted as standard procedure. However, challenges remain, which can result in delayed access by children to innovative medicines. This year’s joint Drug Information Association (DIA)/ European Forum for Good Clinical Practice (EFGCP)/ European Medicines Agency (EMA) annual paediatric conference will focus on ways to overcome these challenges, such as through collaboration, extrapolation, modelling & simulation and adaptive pathways. The conference will provide an opportunity to interact with EMA paediatric coordinators, members of the Paediatric Committee and other stakeholders interested in paediatric drug development. Patients’ and Healthcare professionals’ views will complement the reports of practical experience. ... Read more
On 8 June 2015, the European Medicines Agency is organising a workshop on the therapeutic use of bacteriophages, bringing together experts and stakeholders from the academic, industrial and regulatory sectors to discuss different aspects of using bacteriophages to treat bacterial infections. The aim is to proactively discuss current issues and open questions and reflect on potential ways forward for this therapy with various stakeholders. ... Read more
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