Evaluation of EMA fee system for the approval and monitoring of medicines: public consultation has been launched

Evaluation of EMA fee system for the approval and monitoring of medicines: public consultation has been launched

The European Commission has launched 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. The study, including the public consultation, is carried out by the contractor, RAND Europe and aims to gather information, views and concerns of all groups having an interest in the EMA fee system and its implementation.

The EMA fee system is set up by Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 and implementing arrangements. It provides fee incentives 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 authorization holders such as micro, small and medium-sized enterprises (SMEs). Overall, 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 public consultation will help to assess the extent to which the current fee and remuneration system of the EMA is cost-based, fair, proportionate and not unduly complex.

Each citizen, business, administration, association or other organization with an interest in the EMA fee system and its implementation, is invited to contribute to this consultation by filling an ad hoc online questionnaire by 02/08/2018. However we noted that the majority of the questions requiring direct expertise on the regulatory procedures and EMA fee system seem to be specifically addressed to the pharmaceutical industry while academia and research organisations are not allowed to provide their opinion using this kind of questionaire.More information are available at this link.

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