Table 1.

Major Objections

Questions raised by the EMA on evaluating a new drug are addressed to the applicant in the form of a major objection or “other concern.”47 In order to get a marketing authorization, all major objections need to be satisfactorily resolved by the applicant.47 The ARs were screened for major objections referring to the dose. A dose‐ or schedule‐related major objection may include an unestablished optimal dosing regimen, the unexplored impact of (non)fasted state or of ethnicity on dosing, unjustified dose proposals, or inconsistency of extrapolation from pharmacokinetic dose‐finding evidence to the final proposed dose.47

AR, indicates assessment report; EMA, European Medicines Agency.