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EU Raises Pharmacovigilance Fees
Drugs Regulatory Affairs
The European Commission raised fees that pharmaceutical companies must pay for pharmacovigilance activities by 1.7 percent to keep up with inflation.
For drugmakers, the fee increase is rounded to the nearest €10 ($11.68), with the exception of the annual fee for literature case and IT system monitoring, which is rounded to the nearest €1 ($1.17).
The European Medicines Agency charges two types of fees for pharmacovigilance activities, including procedure-based fees and an annual fee. The procedure-based fees are for periodic safety update reports, assessments of post authorization safety study (PASS) protocols and study results, and pharmacovigilance-related referrals.