Guides and Documents
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
Guides & Documents in English
GMP checklist for ATMP manufacturers – 2020-03-21 (English) – Word
Guide for Investigator´s Brochure for ATMP – 2020-05-08 (English) – Word
Guide for Investigator´s Brochure for ATMP – 2020-05-08 (English) – Online PDF
Guide for Investigational medicinal product dossier for ATMP – 2020-05-08 (English) – Online PDF
Guide for Investigational medicinal product dossier for ATMP – 2020-05-08 (English) – Word
Guide for Clinical study protocol for ATMP – 2020-03-31 (English) – Online PDF
Guide for Clinical study protocol for ATMP – 2020-03-31 (English) – Word Download
Guides & Documents in Swedish
Guide: Labelling of Cells and Tissues Including ATMPs – 2020-11-13 (Swedish) – Online PDF
Guide: Authorisation Map for Health and Medical Care (Swedish) – Online PDF
Guide: Responsibilities and Roles for ATMPs – 2023-01-11 (Swedish) – Online PDF
Guide: Governance and Preparation of Gene Therapies – 2025-07-01 (Swedish) – Online PDF
Guide: Implementation of CAR-T Cell Therapy – A Guide for Hospital Pharmacies (Swedish) – Online PDF