The European Union has agreed major changes to new pharmacovigilance legislation, which came into force this July, to strengthen monitoring procedures used across the continent to ensure the safety of drugs.

The trigger for the latest package of amendments, which was endorsed by the European parliament on 11 September, was the drug safety inquiry launched in France last year (after the EU legislation had been agreed in December 2010) into the drug Mediator.1 Produced by the French company Servier, its main active ingredient was benfluorex to treat type 2 diabetes.

Despite the emergence of adverse reaction reports …