How to use this guide

Photo by: Cell and Tissue laboratory, Sahlgrenska University Hospital

This regulatory guide will provide useful information and insights throughout the Advanced Therapy Medicinal Product (ATMP) development process. In general:

– It is important to document all steps from the start and throughout the whole process from the initial idea to an ATMP.
– Contact Läkemedelsverket or the European Medicines Agency (EMA) at an early stage for advice on your process development plan.

Throughout the process guide, the following topics are presented for each class of ATMP:

– General: information
– Quality (including manufacturing): characterisation, consistency, potency and comparability
– Non-clinical (pre-clinical): adequate animal models, mechanism of action, bio-distribution and safety
– Clinical: safety, long-term efficacy, general endpoints + specific endpoint and duration of follow-up