Induced Pluripotent Stem Cell Therapies in Poland from a Public Health Perspective: Regulatory Deficit and the Untapped Potential of Pharmacists

Iwona Wrześniewska-Wal

doi:10.21697/ejhp.0112.01

Published: 2026-06-30

Vol. 6 No. 1 (2026)

Induced Pluripotent Stem Cell Therapies in Poland from a Public Health Perspective: Regulatory Deficit and the Untapped Potential of Pharmacists

Iwona Wrześniewska-Wal

European Journal of Health Policy, Humanization of Care and Medical Ethics

Section: Articles

https://doi.org/10.21697/ejhp.0112.01

Abstract

A substantial part of this study consists of an analysis of the legal framework governing advanced therapy medicinal products (ATMPs), including the hospital exemption mechanism. The author highlights the lack of uniformity in the regulatory framework across the European Union and the differences in the approaches adopted by jurisdictions such as the United States, Japan and Switzerland. The aim of the paper is to evaluate Polish regulations against the international background and to identify possible directions for their further development, particularly in the context of planned legislative changes and the potential role of the pharmacist within the system.

Keywords:

induced pluripotent stem cells, iPSCs, pharmacist, advanced therapy medicinal products, ATMPs

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