RAPS: EMA Updates Two Pharmacovigilance Guidelines

Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU.The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2), which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1), which takes effect on 12 August 2015.