Advanced therapy medicinal products: Regulatory framework, hospital and pharmaceutical circuits in Europe and France

Miryam Mebarki; Isabelle Madelaine; Jérôme Larghero; Romain de Jorna

doi:10.1016/j.therap.2021.11.005

Advanced therapy medicinal products: Regulatory framework, hospital and pharmaceutical circuits in Europe and France

Therapie. 2022 Mar-Apr;77(2):185-190. doi: 10.1016/j.therap.2021.11.005. Epub 2021 Nov 26.

Authors

Miryam Mebarki¹, Isabelle Madelaine², Jérôme Larghero³, Romain de Jorna²

Affiliations

¹ Unité de thérapie cellulaire, université de Paris, hôpital Saint-Louis, AP-HP, 75010 Paris, France; Inserm, centre d'investigation clinique de biothérapies CBT501 et U976, 75010 Paris, France. Electronic address: [email protected].
² Pharmacie à usage intérieur, université de Paris, hôpital Saint-Louis, AP-HP, 75010 Paris, France.
³ Unité de thérapie cellulaire, université de Paris, hôpital Saint-Louis, AP-HP, 75010 Paris, France; Inserm, centre d'investigation clinique de biothérapies CBT501 et U976, 75010 Paris, France; Centre MEARY de thérapie cellulaire et génique, université de Paris, hôpital Saint-Louis, AP-HP, 75010 Paris, France.

PMID: 34895758
DOI: 10.1016/j.therap.2021.11.005

Abstract

Advanced therapy medicinal products (ATMPs) represent a new class of biological medicines. The European regulation has classified ATMPs into three categories: gene therapy medicinal products, somatic cell therapy medicinal products, and Tissue-Engineered products. If one of these categories incorporates a medical device, the medicine is defined as a Combined ATMP. The specificity and complexity of these innovative drugs have required a complete reorganization of hospital and pharmaceutical circuits, from patient eligibility to drug administration. Indeed, increased interaction and collaboration between different healthcare professionals are essential in order to guarantee quality and safety of these innovative medicines.

Keywords: Advanced therapy medicinal products; European and French regulation; Pharmaceutical and hospital circuits.

MeSH terms

Europe
European Union
France
Genetic Therapy*
Hospitals*
Humans
Pharmaceutical Preparations

Substances

Pharmaceutical Preparations