Posted by Michael Wonder on 11 Dec 2019
Six-year review shows success of the EU signal management system in improving safe use of medicines
11 December 2019 - In the first six years since the implementation of the 2012 EU pharmacovigilance legislation, the EU network has demonstrated its ability to reliably detect, assess and manage safety signals for medicines, opening a new era for patient protection and transparency in medicines safety, highlights an article published in Clinical Pharmacology & Therapeutics.
Pharmacovigilance systems ensure proactive monitoring of all authorised medicines throughout their lifecycle in clinical use. Signal detection and management are core activities in pharmacovigilance, rapidly delivering new information on the safety of medicines in real-world use which helps to fill knowledge gaps.
At the heart of this process is a strong collaboration based on expertise from the national competent authorities and EMA, with the contribution of the pharmacovigilance systems of marketing-authorisation holders, combined with a culture of continuous improvement.
