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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

Featured information

News for media

Events of interest

  • 18/05/2018

    EMA

    Third industry stakeholder platform on research and development support

    This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine development programmes, co-development with companion diagnostics and cross-decision maker collaboration in the space of horizon scanning activities. It also provides an opportunity for updates on post-authorisation evidence generation activities, paediatric medicines and the PRIME scheme. ... Read more

  • 26/10/2018

    EMA

    Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers

    The SME info day provides an update on regulatory affairs topics for developers of human medicines and combined devices. It covers subjects such as data exclusivity and market protection, orphan and paediatric rewards, legal basis for submission of a marketing authorisation application, conditional marketing authorisations and approvals under exceptional circumstances, classification of advanced therapies and EMA activities in relation to the new medical device legislation. An update on Brexit-related activities will also be provided at the end of the event. The 'Meet EMA' event will provide an opportunity for SMEs to engage with EMA staff from different departments to increase awareness of the range of support available at EMA. The event is open to companies that have been assigned SME status by EMA and to representatives of stakeholder organisations. It will be broadcast and recorded for interested parties to follow the proceedings. ... Read more

  • 23/03/2018

    EMA

    Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products

    The purpose of this meeting is to update European Union trade associations on the Agency's Brexit preparedness activities. ... Read more

  • 04/05/2018

    EMA

    Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

    The aim of this workshop is to inform thinking on big data and related challenges as the HMA/EMA Joint Big Data Task Force is planning to make recommendations in this field in November 2018. In 2017, the task force undertook detailed landscaping of the entire big data field (genomics through to m-health) as viewed through the lens of the regulator. It also performed online surveys of both national regulatory agencies and the pharmaceutical industry on perspectives, expertise and challenges. This work helped develop an understanding of the challenges and the current state of expertise in the regulatory network. The taskforce now aims to move onto considering solutions. The task force was established in March 2017 to identify the emerging challenges created by the increasing availability of data and related opportunities for supporting regulatory decision-making. ... Read more

  • 20/04/2018

    EMA

    Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure

    The European Medicines Agency is holding this meeting to inform veterinary companies on Brexit regulatory preparedness for centrally authorised products and address any specific questions they may have further to the publication of European Commission and EMA questions and answers document and EMA procedural guidance. This event is targeting small and medium enterprises’ needs (SMEs) and is also open to all companies and stakeholders developing veterinary medicinal products. ... Read more

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