EMA Raises Industry Fees For EU Pharmacovigilance Services
Companies using the European Medicines Agency’s drug safety services will be paying more from 3 October.
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The publication of a draft EU Regulation governing the fees paid by the pharmaceutical industry to the European Medicines Agency is the latest step in a long process aimed at ensuring that the payment system better reflects the actual costs of the regulatory work carried out or coordinated by the EU regulator.
This year’s new fee structure at the EMA takes account of the inflation rates in 2020 and 2021 and includes changes relating to inspections and companion diagnostics.
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.