Giovanna Franciosa, Serena Guida, Maria Jesus Gomez Miguel, Christina Von Hunolstein
{"title":"Live biotherapeutic products and their regulatory framework in Italy and Europe.","authors":"Giovanna Franciosa, Serena Guida, Maria Jesus Gomez Miguel, Christina Von Hunolstein","doi":"10.4415/ANN_23_01_09","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"59 1","pages":"56-67"},"PeriodicalIF":1.1000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annali dell'Istituto superiore di sanita","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4415/ANN_23_01_09","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
Annali dell’Istituto Superiore di Sanità is a peer reviewed quarterly science journal which publishes research articles in biomedicine, translational research and in many other disciplines of the health sciences. The journal includes the following material: original articles, reviews, commentaries, editorials, brief and technical notes, book reviews.
The publication of Monographic Sections has been discontinued. In case you wish to present a small number of coordinated contributions on specific themes concerning priorities in public health, please contact the Editorial office.
The journal is in English.
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