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Today, the Commission launches a public consultation as a part of a study supporting the evaluation of the fee system for the European Medicines Agency’s (EMA) activities relating to the approval and monitoring of medicines for people and animals. Input will help the study team to assess the extent to which the current fee and remuneration system of the EMA is cost-based, fair, proportionate and not unduly complex.
If you are a citizen, business, administration, association or other organisation with an interest in the EMA fee system and its implementation, you are invited to contribute to this consultation by filling in the online questionnaire* by 02/08/2018. Please note that some of the questions are more specifically addressed to the pharmaceutical industry, academia and research organisations that have active experience with the operation of the EMA fee system.
Background
The European Medicines Agency is the EU’s central regulatory body operating centralised pre- and post-authorisation procedures for medicinal products for human and veterinary use across the EU and the European Economic Area (EEA). The EMA works in close collaboration with national competent authorities (NCAs) in the EU and EEA Member States. NCAs are represented in the EMA committees and working parties and in this setting they carry out assessments of medicinal products for human and veterinary use in the context of EU-wide marketing authorisations.
EMA is funded by contributions from the EU budget as well as fees paid by businesses. EMA remunerates NCAs for provision of services related to centralised procedures at EU-level. The rules are laid down in the Fee Regulation and the Pharmacovigilance Fee Regulation. Fee incentives are provided for specific types of products (including medicines for rare diseases, medicines for children, advanced therapies, and veterinary medicines for minor use/minor species) and specific applicants and marketing authorisation holders such as micro, small and medium-sized enterprises (SMEs).
This public consultation is part of a study supporting the evaluation of the EMA fee system. The study, including the public consultation, is carried out by the contractor, RAND Europe. It aims to gather information, views and concerns of all groups having an interest in the EMA fee system and its implementation.
For more information:
* French: https://ec.europa.eu/eusurvey/runner/evaluation_ema_fee_system?surveylanguage=fr
German: https://ec.europa.eu/eusurvey/runner/evaluation_ema_fee_system?surveylanguage=de
