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Ph. Eur. consults on new quality standards for Live Biotherapeutic Products

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European Pharmacopoeia
Standard Terms
Press release
06 April 2017
Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is consulting the public on three new texts, which for the first time in Europe, propose harmonised quality standards for Live Biotherapeutic Products (LBPs) used in human healthcare.

LBPs are medicinal products containing living micro-organisms such as bacteria or yeasts, which have a positive influence on the health and physiology of the host. The most common species are the bacteria Lactobacilli, Bifidobacteria, some Streptococcal species, Bacillus clausii, and the yeast Saccharomyces cerevisiae var boulardi. However, while many LBPs are available on the European market, there are currently no standards at European level ensuring their quality and thus protecting the health and safety of patients across the Ph. Eur. Member States.

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