Live biotherapeutic products and their regulatory framework in Italy and Europe

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Abstract

In Italy and Europe, live microorganisms-containing products meant to be used by vulnerable or sick people for preventing or curing a disease are defined as live biotherapeutic products and are regulated as biological drugs. As such, they must undergo extensive quality, safety and efficacy testing and evaluation before receiving a marketing authorization. This review describes the regulatory framework of live biotherapeutic products with special focus on the European Pharmacopoeia monograph 3053 that set mandatory requirements for this kind of medicines, including verification of the number of live microorganisms and absence of certain contamination indicator microorganisms. The other product categories that may contain live microorganisms are also described, with brief references to the overlaps possibly occurring between the different categories.

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Authors

Giovanna Franciosa - Istituto Superiore di Sanità

Serena Guida - Ageniza Italiana del Farmaco

Maria Jesus Gomez Miguel - Istituto Superiore di Sanità

Christina Von Hunolstein - Istituto Superiore di Sanità

How to Cite
Franciosa, G., Guida, S. ., Gomez Miguel, M. J., & Von Hunolstein, C. (2023). Live biotherapeutic products and their regulatory framework in Italy and Europe. Annali dell’Istituto Superiore Di Sanità, 59(1), 56–67. https://doi.org/10.4415/ANN_23_01_09
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