European Medicines Agency - News and Events - EMA’s proactive publication of clinical data a success

acavaminombre's bookmarks 2018-07-17

Summary:

"The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). Under this policy citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorisation applications for new medicines as of 1 January 2015. Clinical reports give information on the methods used and results of clinical trials conducted to demonstrate the safety and efficacy of medicines. The report covers one year from the launch of EMA’s clinical data website on 20 October 2016 and lists the 50 medicines for which clinical data were published, including orphan, paediatric, biosimilar and generic medicines, as well as the corresponding 54 regulatory dossiers. These data have attracted a total of 3,641 users, resulting in 22,164 document ‘views’ and 80,537 ‘downloads’ for non-commercial research purposes."

Link:

http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fnews_and_events%2Fnews%2F2018%2F07%2Fnews_detail_002990.jsp&mid=WC0b01ac058004d5c1

From feeds:

Open Access Tracking Project (OATP) » acavaminombre's bookmarks

Tags:

Date tagged:

07/17/2018, 14:00

Date published:

07/17/2018, 10:00