Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the current European system in 1995. The background to the forthcoming changes dates back to 2003 when the European Commission decided to undertake an assessment of the pharmacovigilance system. Independent review and public consultation followed, as well as further work at the Commission, the European Medicines Agency (EMA) and EU member states, resulting in the publication of Regulation (EC) 1235/2010 and Directive 2010/84/EC on 31 December 2010.
The overriding purpose of the new package is to strengthen the public health system through better pharmacovigilance. All areas of post-marketing activities are subject to revision from ADR reporting, signal management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post Authorization Safety Studies (PASS).
As well as the public health angle the new legislation also seeks to improve efficiency by having improved decision-making processes, reducing duplication and making better use of IT through the use of centralized systems and standards.
However, not all of the new measures will come into effect immediately and a period of transition will apply in a number of areas.
Marketing Authorization Holders (MAHs) and other stakeholders should refer to the EC Implementing Measures and the Good Vigilance Practice Modules produced by the EMA and member states.
This article hopes to highlight areas of interest to medical writers, identifying what the major changes are and when they come into play.