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February 2019

EURORDIS response to European Ombudsman strategic inquiry into pre-submission activities organised by the European Medicines Agency

The European Ombudsman has requested the opinion of interested parties on how the European Medicines Agency conducts pre-authorisation activities on medicines. This document is the EURORDIS response to that inquiry, setting out why the current system is robust and vital to ensure that clinical development is well designed and with input of patients.

(January 2019)