Posted by Michael Wonder on 21 Oct 2019
Enhancing consistency in wording of therapeutic indications to support health care decision-making
21 October 2019 - EMA’s human medicines committee has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines.
The document is intended to guide assessors in the national competent authorities who are responsible for evaluating marketing authorisation and extension of indication applications received by EMA. It outlines key elements that assessors should consider when evaluating the therapeutic indications proposed by the applicant, for example, whether a medicine is considered as first- or second-line treatment and whether it should be used in combination with another product.
In this context, the paper takes into account some of the needs of healthcare decision-makers such as healthcare professionals and health technology assessment bodies.
