Links
GMP Publishing Peither, Inc.:
https://www.gmp-publishing.com/content/en/gmp-info/what-is-gmp
Paul-Ehrlich-Institut:
Arzneimittel für neuartige Therapien // ATMP – Advanced Therapy Medicinal Products
Regulatorische Anforderungen und Praktische Hinweise
European Commission:
EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
https://data.consilium.europa.eu/doc/document/ST-5389-2024-INIT/en/pdf
EMA - European Medicines Agency:
CAT’s views on classification of ATMPs: homologous use
Advanced therapy medicinal products (ATMPs) and ATMP Regulation