European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan.

The new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate mainly to the reporting of adverse drug reactions (ADRs) for the detection of safety and efficacy defects. They also cover quality problems such as deficiencies in manufacturing, inadequacies in formulations, including excipients, as well as faulty drug-delivery technologies.

EMA claims that the new pharmacovigilance legislation, implemented in mid-2012 in both the EU and the two non-EU countries of Norway and Iceland, has “brought about the biggest change to the legal framework for human medicines” in Europe since the creation of the central agency itself in 1995. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has already “made great strides towards a new era in protecting public health,” according to its chair June Raine.

Nevertheless, as the pharmacovigilance infrastructure gradually becomes more entrenched in Europe, drug manufacturers and other marketing authorization holders (MAHs) are complaining that they are shouldering an unfair proportion of its high costs.

For more on this Pharm Tech article by Sean Milmo, click here.