ATMP regulatory guide

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

Contact Läkemedelsverket or the European Medicines Agency (EMA) at an early stage for advice on your process development plan.

This guide for ATMPs will help you through the important steps from process development to clinical use. In this guide you have the possibility to navigate through the general steps for clinical trial and all the different classifications.

For more information on the guide or for comments and suggestions please contact Ann Novotny

You can learn more about the Swelife-ATMP regulatory project that are developing these resources on their Project page