European Commision (EC) proposal for regulation of EMA fees
The process of obtaining marketing authorization for a medicine requires companies to pay a fee to the EMA for their assessment services. This fee covers not only the evaluation conducted by the agency but also the compensation provided to national authorities involved in the assessment.
In recent months, EMA has proposed a new regulation concerning the fees charged for its services. The proposal aims to establish a more transparent and predictable fee system for the pharmaceutical industry.
The current fee system of the European Medicines Agency (EMA) is intricate due to the diverse range of services and activities it undertakes, often in collaboration with national authorities.
Within this system, fees are categorized into three types: procedural fees, administrative fees, and annual fees.
Procedural fees pertain to specific services offered before or after the granting of a marketing authorization for a medicinal product. The fee amount is determined by the complexity of the data evaluation required and the type of product (human or veterinary). There are approximately 90 different basic procedural fees for human and veterinary medicinal products, with the possibility of additional charges.
Annual fees are associated with horizontal activities related to marketing authorizations. There are two types of annual fees:
- An annual fee for centrally authorized products (CAPs) intended for human and veterinary use.
- A pharmacovigilance annual fee for nationally authorized products (NAPs) designed for human use. The amount payable by each market authorization holder for pharmacovigilance annual fees depends on the number of “chargeable units.”
Administrative fees are applicable for administrative services such as document processing, certificate issuance, cases of negative validation of applications, and checks for parallel distribution.
The primary objective of the EC proposal for the regulation of EMA fees is to ensure a fair and sustainable funding model for the agency’s activities. By implementing a transparent fee structure, the EMA aims to provide predictability and clarity to the pharmaceutical industry regarding the costs associated with the evaluation and authorization of medicinal products.
In conclusion, the EC proposal for the regulation of EMA fees presents a positive step toward enhancing transparency, predictability, and fairness in the pharmaceutical regulatory landscape. By striking a balance between cost recovery and affordability, incentivizing innovation, and collaboration, and ensuring quality and efficiency, the proposed regulation has the potential to benefit both the pharmaceutical industry and patients. It is imperative that all stakeholders engage in constructive dialogue to refine and implement this regulation, ultimately contributing to the advancement of public health in Europe.
