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EMA (European Medical Agency) communication

EMA

As you may know, the European Medicines Agency (EMA) launched the clinical data website on 20 October 2016 in line with its policy on the publication of clinical data(Policy 0070). EMA is dedicating a significant amount of time and effort to this activity. Whilst extensive stakeholder consultation on the policy took place during its development, it is important to get more information on the experience gained during the first few months following the launch of the website. Concrete information on who is accessing the clinical data, why users access the data, and how useful the data have been could help to further develop EMA’s transparency policies. In addition, it will be useful to gather feedback on the usability of the new website.

Clinical data website: https://clinicaldata.ema.europa.eu/

Policy on publication of clinical data: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000555.jsp&mid=WC0b01ac05809f363e

Therefore, EMA has launched a survey to collect the views of the users of the clinical data website and to gather feedback on the usability of the website. The survey should take no more than 10 minutes to complete and is available until 31 August 2017.

Thank you for disseminating this message and participating in the survey.

Start the survey: https://ec.europa.eu/eusurvey/runner/clinical_data_publication_survey (click on the "questionnaire" tab)
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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

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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

EMAS

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