Published by EMA on 05-May-2014 The European Medicines Agency has published an updated list of active substances contained in authorised medicines for which a lead Member State has been appointed to monitor data in EudraVigilance, in order to validate and confirm signals…

Published by EMA on 19-Feb-2014   The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on pharmacovigilance (medicine safety) topics. Building on the experience of previous regular videoconferences between the EMA and the FDA in…

Published by EMA on 31-Jan-2014 Over 40% of innovative medicines recommended for marketing authorisation in the European Union (EU) between 2010 and 2012 originated from small or medium-sized enterprises (SMEs), academia, public bodies and public-private partnerships, according to an article published today…

Some of the Pharmacovigilance-related Guidances planned to be Published in 2014 (New & Revised) Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Providing Regulatory Submissions in Electronic Format – Postmarketing Safety Reports Adverse Events: Collection and…