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

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:

Word-format 1.0, PDF-format 1.0 

Guide for Investigator´s Brochure for ATMP:

Word-format 1.0, PDF-format 1.0

Guide for Investigational medicinal product dossier for ATMP:

Word-format 1.0, PDF-format 1.0

Guide for Clinical study protocol for ATMP:

Word-format 1.0, PDF-format 1.0

If you have input on these guides, please Contact SDP1 Project leader Ann Novotny