EMA Issues Guide on Consistency of Indication Wording

Regulatory NewsRegulatory News | 21 October 2019 |  By 

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.
For instance, when defining the disease or condition, EMA says reviewers should define the target “in a way that is well recognized in clinical practice” and explains how the effect of the product should be defined.
Similarly, when discussing a product’s place in therapy, EMA stresses that reviewers should consider whether the product was studied in a “defined treatment pathway” and consider whether it is appropriate to specify if the product is intended for first- or second-line use.
EMA says that defining a product’s therapeutic indication “requires a multidimensional analysis” and should take into account the data included in the application, the therapeutic context and whether the benefits and risks identified in studies apply to the target population.
The agency emphasizes that “the scientific basis for and the reasoning behind the final wording of the indication should be clearly documented in the CHMP assessment report.”
The guide also provides a template for wording the therapeutic indication that takes the various components into account:
“<Diagnostic use >or <Preventive> or <Symptomatic, curative or disease modifying (if applicable)> <treatment of> <{severity criteria if applicable}> <{target disease or condition}> in <{age group}> patients < {restrictions to patient population, if applicable}> <{restrictions in terms of therapeutic option or prior therapy, or other restrictions, if applicable}> <in combination with other medicinal products <{list relevant combinations, if applicable}><in monotherapy><{Mandatory conditions of product usage not covered more appropriately in other parts of the SmPC}>”
EMA, Guide


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