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EMA (European Medical Agency) communication

EMA


We are pleased to inform you that the European Commission has published 6 new language versions of the patient information document "What you need to know about biosimilar medicines", so that patients now have access to unbiased and reliable information in English, French, German, Italian, Polish, Portuguese and Spanish. The information document can be downloaded and printed here: Commission publishes Q&A on biosimilar medicines for patients:
http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9066

More information on activities related to biosimilars can be found on the European Commission website:
https://ec.europa.eu/growth/sectors/healthcare/competitiveness/corporate- responsibility_en

Please also note that the next European Commission multi-stakeholder workshop on biosimilars will be held on 5 May 2017 in Brussels.
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The European Medicines Agency has published an overview of its key recommendations of 2016 in relation to the marketing authorisations of new medicines and the safety monitoring of authorised medicines. In 2016, EMA recommended 81 medicines for marketing authorisation, including 27 new active substances:
http://www.ema.europa.eu/ema/index.jsp? curl=pages/news_and_events/news/2017/01/news_detail_002678.jsp&mid=WC0b01ac 058004d5c1

A selection of these recommendations can be found in the human medicines highlights document available by clicking here:
http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/01/WC500 219736.pdf

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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The European Medicines Agency has released for public consultation a concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products'.

The current guideline mainly focuses on non-clinical aspects of drug development and the use of animal data and reflects the practice at the time it was developed which focused on a single ascending dose (SAD) design for first-in-human (FIH) trials. Since then, integration of the non-clinical data available before FIH administrations and the pharmacokinetic (PK), pharmacodynamic (PD) and human safety data emerging during a trial has also evolved. Consequently, the practice has evolved and many FIH trials are now performed with integrated protocols potentially combining a number of different study parts, e.g. single and multiple ascending doses (SAD and MAD), food interaction, different age groups and early proof of concept or early proof of principle parts. FIH and early phase CTs with multiple study parts are, therefore, increasingly being submitted for regulatory review to National Competent Authorities as part of a single CT application.
The document open for consultation is available by clicking here:
http://www.ema.europa.eu/ema/doc_index.jsp? curl=pages/includes/document/document_detail.jsp? webContentId=WC500210825&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/W C500004016.doc


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We would like to draw your attention to the publication of the European Commission call for expression of interest related to the appointment of alternates representing clinicians at the Committee for Advanced Therapies (CAT) of the European Medicines Agency.

For more information, please click here:
http://ec.europa.eu/health/documents/public_call/call_index_en.htm

Expressions of interest must be submitted to the European Commission by 30 September 2016 at the following address: SANTE-CONSULT- A3@ec.europa.eu

EMAS

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