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)
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:
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
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