Risk assessment and early documentation

Due to the specific nature of ATMPs, a risk-based approach is necessary to determine the extent of quality, non-clinical and clinical data (including risk management plan and pharmacovigilance activities) to be performed.

Due to the risk aspect, early contact with Läkemedelsverket and EMA is important. A strategy to determine risk according to the marketing process is to follow the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to ATMP.