Euroope – EMA Issues Guide on Consistency of Indication Wording

The European Medicines Agency (EMA) on Monday released a guide developed by its Committee for Medical Products for Human Use (CHMP) on factors reviewers should consider to ensure the wording of therapeutic indications is consistent across products.

“Stakeholders, who rely on this information for their work, have raised concerns that therapeutic indications may be worded inconsistently and can contain varying levels of detail,” EMA writes, noting that more consistent and detailed indications can benefit healthcare professionals, health technology assessment (HTA) bodies and payers.

Specifically, the eight-page guide is aimed at providing reviewers with a more consistent approach to defining therapeutic indications and clarifying the framework for assessing indications to promote more consistent wording of therapeutic indications in Section 4.1 of the summary of product characteristics (SmPC).

Within the guide, EMA lays out five elements of the indication for reviewers to consider, including the target disease or condition; target patient population; the product’s place in therapy; whether the product is intended for monotherapy or use in combination with other therapies; and whether there are any other mandatory conditions for the product’s use…