European Medicines Agency’s new guide on the wording of therapeutic indication

On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in therapeutic indications. The therapeutic indication is the primary information concerning the use of a medicinal product. The guide provides that therapeutic indications should clearly state the disease/condition and population that a medicinal product is intended to treat. The objective of the guide is to provide a consistent approach in defining therapeutic indication. Therefore, it provides guidance concerning appropriate wording that may be applied across therapeutic areas.

Click here to view the full article.

Share Back to main blog
Loading data