EMA: Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products

This guideline describes the intention of the risk-based approach and details its methodological application. The methodology is based on the identification of risks and associated risk factors of an advanced-therapy medicinal product and the establishment of a specific profile for each risk. With the use of the identified risk profile the applicant shall justify the extent of data presented in the various sections of the marketing-authorisation application dossier.