EMA (EUROPEAN MEDICAL AGENCY) COMMUNICATION

EMA launches new corporate website

The European Medicines Agency (EMA) has launched a new version of its corporate website today: https://www.ema.europa.eu/en/news/ema-launches-new-corporate-website

The website has a number of new features to improve user experience, including:

  • an improved search, allowing users to find content easily and to filter their search results. EMA plans to further refine this functionality in the future;
  • a ‘responsive’ design for cleaner display on mobile devices;
  • a simpler URLs based on the location and title of webpages or documents;
  • an updated visual design offering users a clearer reading experience and simpler navigation.

The website’s content and structure remain unchanged. Although the site’s URLs are new, URLs from the previous website will continue to work for every page and document, thanks to one-to-one redirects. Although these redirects will be available for an indefinite period, EMA encourages users who have bookmarked any URLs to consider updating them at their convenience now that the new site is live.

The new website has been designed to work optimally on the latest web browsers. EMA carried out the project to relaunch the website in collaboration with the European Commission’s Directorate General for Informatics (DIGIT).

DIGIT will also host and maintain the new website on behalf of EMA.

To provide general feedback on the new EMA’s corporate website or to make suggestions for future improvement, please write to newwebsite@ema.europa.eu. EMA will take all feedback and suggestions into account, but will not be able to reply to individual email messages.

EMA Consultation: Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products – Revision 1

The European Medicines Agency has released for public consultation a draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products – Revision 1.

The aim of this guideline is to provide the guidance for the Safety and Efficacy (S&E) follow-up and risk management for advanced therapy medicinal products (ATMPs) according to Article 14(4) of Regulation (EC) No 1394/2007. This regulation requires the European Medicines Agency (EMA) to develop a detailed guideline relating to the post-authorisation follow-up of efficacy and adverse reactions, and risk management for these products.

This is the 1st revision of the original ATMP guideline on safety and efficacy follow-up and risk management; the guideline has been revised to take into consideration the experience gained with the authorisation of these products and to define their risks and their risk minimisations measures. In addition, guidance on methodology in order to design post-authorisation S&E follow-up studies is provided.

The draft guideline is available by clicking here:http://www.ema.europa.eu/ema/doc_index.jsp? curl=pages/includes/document/document_detail.jsp? webContentId=WC500242959&murl=menus/document_library/document_library.jsp&mi d=0b01ac058009a3dc

Comments should be provided using this template :http://www.ema.europa.eu/docs/en_GB/document_library /Template_or_form/ 2009/10/WC500004016.doc
and sent to atmpguideline@ema.europa.eu by 30/04/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations.

For more information, see Specific privacy statement for public consultations http://www.ema.europa.eu/ema/pages/includes/docum ent/open_docume nt.jsp?webContentId=WC500127419
For more information on the European regulatory system for medicines, please consult our brochure: http://www.ema.europa.eu/docs/en_gb/document_library/leaflet/2014 /08/w c500171674.pdf