EFPIA CALLS FOR MORE ROBUST RULES ON PHARMACOVIGILANCE STUDIES
April 1st, 2013
THE EUROPEAN Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Union (EU) to solidify rules for staging post-authorisation efficacy studies, saying the pharma industry needs more clarity on when they are held and their potential consequences.Commenting on a European Commission consultation paper on such pharmacovigilance assessments, the EFPIA called for new legislation. It said: “Obtaining clarity and predictability on expectations for when PAES [post-authorisation efficacy studies] may be required and ensuring that ...
Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.