Module232025

07/05/2025

Determining the condition

 Elements to consider: 1. Indication proposed by the applicant (or authorised indications) 2. Treatment, diagnosis, prevention? 3. “Properties of the medicinal product” (mechanism of action) 4. Independent classification of diseases and conditions (e.g. MedDRA) 5. Paediatric needs

The Organisation for Professionals in Regulatory Affairs

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One possible classification system:

(therapeutic areas)

(conditions)

(indications)

Slide from Janina Karres, EMA

The Organisation for Professionals in Regulatory Affairs

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