EMA Issues Guide on Defining Therapeutic Indications During Application Reviews

The European Medicines Agency (EMA) has issued guidance for reviewers to use to define therapeutic indications during their reviews of applications for new indications and new active substances.

Therapeutic indications serve as the starting point for assessing relative effectiveness, but concerns have been raised “that therapeutic indications may be worded inconsistently and can contain varying levels of detail,” the EMA said.

The eight-page guidance lists components that assessors should keep in mind when defining a therapeutic indication, including the target disease or condition, target population, use in monotherapy/combination therapy, and the place in therapy, whether first line or second line.