EMA (European Medical Agency) communication


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


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