Health policy news

Fees for drug safety checks

Added: Monday 5 August 2013

The European Commission has adopted a proposal for pharmaceutical companies to pay specific fees for drug safety activities. The new drug safety (pharmacovigilance) legislation increases the responsibilities of the European Medicines Agency (EMA) and these activities need to be financed. Reductions will be available for small and medium-sized enterprises (SMEs). There will also be an annual flat fee for all companies holding marketing authorisation for medicinal products on sale in the EU. The full text of the proposal can be read here.