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This section of the website contains the European Medicines Agency's news and press releases, information on meetings and events, public consultations and related information.

For a scrolling feed of all of the new and updated information published on the website, see the what's new page.

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This month's events

November 2017

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  • 2017-11-23 - 2017-11-24 :

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    This eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course has been prepared to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

  • 2017-11-23 - 2017-11-23 : CHMP

    Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

    The term ‘prior knowledge’ can refer to both a company’s proprietary knowledge of formulation and manufacturing development of medicinal products and external knowledge from published scientific literature. The use of such prior knowledge to support the development of product formulations, manufacturing processes and control strategies, could be justifiable in certain circumstances. Through a combination of presentations, industry case studies and panel discussions, this joint workshop with regulators and the pharmaceutical industry aims to reach an agreed understanding on what is (and isn’t) considered to be prior knowledge, how can such prior knowledge be used in regulatory submissions, how to justify its use and how to present it in the dossier. EMA will publish a report with conclusions from the workshop. It may also consider further follow-up guidance.