Guides and Documents

We hope that these guides will assist you in the development and approval of your ATMP!

The following guidance documents have been created by the Swelife-ATMP project SDP1-regulatory and the ATMP2030 Innovationmilieu.

The absence of detailed guidance for Advanced Therapy Medicinal Product (ATMP) development initiated the development of these guidance documents which we suggest should be used in combination with our public regulatory guide. Please, remember that each ATMP is unique.

Guides for ATMP

GMP checklist for ATMP manufactures:


Guide for Investigator´s Brochure for ATMP:


Guide for Investigational medicinal product dossier for ATMP:


Guide for Clinical study protocol for ATMP:

Word-Clinical study protocol, PDF-Clinical study protocol

Guide: Märkning av celler och vävnader inklusive ATMP:

PDF-Märkning av celler och vävnader

Guide: Tillståndskarta för hälso- och sjukvård


Guide: Sjukhusapoteksfunktionens roll vid Avancerade cell- och genterapier

PDF Sjukhusapoteksfunktionens roll

Guide: Ansvar och roller för ATMP

PDF-Ansvar och roller ATMP