Medicines for Europe, the trade body for generics and biosimilars companies in the region, has called for “a fair, cost-based approach” to regulatory fees.
The group is arguing for a simpler fee structure, as well as adequate financing and “transparent evaluation of costs,” during the regulatory process for medicines.
Stressing the increased significance of regulatory fees for medicines which attract a lower price, Medicine for Europe said this approach would help avoid the withdrawal of older medicines from national markets, which may be essential for healthcare needs.
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