Clinical overview – eCTD module 2.5

The Clinical Overview is one of the most important documents on your way to Marketing Authorisation. It is an in-depth critical analysis of your complete drug development programme and its results, including discussion and interpretation of clinical findings.

The overview presents the strengths and limitations of your programme and study results and analyse clinical benefits and risks. It describes how study results support the critical parts of the prescribing information, such as indication, dosage, safety profile and more.

A clinical overview is needed also for generic- and hybrid applications but in these cases the key messages could generally be based on the reference product.
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