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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.
For more information, please contact the EMA press office.
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News for media professionals
Joint workshop with International Society for Cellular Therapy to take place on 25 September 2015 in Seville, Spain ... Read more
Ten new medicines, including two enzyme replacement therapies for rare diseases, recommended for approval ... Read more
Kanuma is first treatment for rare life-threatening genetic disease causing multiple organ damage ... Read more
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Events of interest
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
Committee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (ISCT) workshop: challenges and opportunities for a successful development and approval of advanced therapy medicinal products
The workshop is co-organised by the European Medicines Agency's (EMA's) Commitee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (ISCT) and will take place during the ISCT Europe 2015 regional meeting. During this workshop, CAT wants to reach out to advanced therapy medicinal products (ATMP) developers from academia, hospitals and industry with a programme aiming to provide insight of CAT's considerations and expectations on quality development and manufacturing issues, non-clinical testing and clinical development of ATMPs. The programme includes also a talk on the EMA/CAT support available to ATMP developers and will allow interacting directly with the regulators in an open forum discussion. Registration by invitation only. ... Read more
Current status of European Medicines Agency policy on publication of clinical data - Stakeholder webinar
The European Medicines Agency (EMA) is organising a webinar on the implementation of its policy on publication of clinical data for medicinal products for human use, which came into effect on 1 January 2015. The aim of the webinar is to update stakeholders on the progress the Agency has made on the implemetation of the policy. The topics covered by the webinar will include an explanation of the principles for the submission of redacted clinical reports, the redaction consultation process, as well as guidance on what is and is not considered commercially confidential information and on the anonymisation and redaction of personal data in clinical reports. Registration closed. ... 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
CAT engages in active dialogue with its interested parties on a regular basis. During its December 2014 annual meeting CAT and its interested parties discussed the following scientific topics: the revision of the CAT reflection paper on classification with a special emphasis on CAT’s current considerations on ‘substantial manipulation’ and ‘non-homologous use’; the application of the concept of risk-based approach during the development and marketing authorisation of advance-therapy-medical products (ATMPs); the CAT work plan for 2015-2016 and other procedures and support to ATMP developers. Other issues and questions from the participating interested parties were also addressed. Registration by invitation only. ... Read more
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