Blog: Focus On Regulation | 12 November 2019

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.

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