IA Study & Consultation Material

Stakeholder consultation in the form of a targeted survey constitutes an important part of the study to support the Commission IA of the EMA fee system. The targeted survey aims to elicit information, views and concerns of all interested stakeholders regarding the impact of the potential revisions to the EMA fee system.

You have been invited to contribute to this consultation and will have received a request to complete the survey through an email sent by the contractors, ICF and RAND Europe. You may have also received the request to complete the survey from your organisation or a representative organisation in your sector.

If you do not have a link to the survey, and believe you should have received one, please contact the study team at EMAFeeSystem_Study@icf.com .

The information provided here is intended to be used to support your completion of the survey.

The supporting materials are as follows:

• A description of the policy options and sub-options, including information on the revisions to the options in light of the feedback to the IIA and subsequent changes to the EMA fee system.
• These provide additional detail to the summary tables provided in the survey (and are also reproduced in the files below):
     - Unitary cost-based fee and remuneration tables for the main options (policy options 1-3): interim result of study model
     - Unitary cost-based fee and remuneration tables for the sub-options (policy options 1-3): interim result of study model
     - EMA budget summary tables: estimated impacts under the options: interim result of study model


• A table of country coefficients to assist respondents with questions about remuneration where the coefficients are introduced
• A methodology note, describing the modelling approach and assumptions underlying the impacts as presented in the survey and other supporting materials.

The study team is compiling a list of frequently asked questions, which will be updated as the consultation progresses. You can find the latest FAQs here.