Reclassification of Vaginal Probiotics in the EU as Pharmaceutical Drugs

The field of microbiome-based therapeutics is flourishing. The recent approval of Seres Therapeutics’ drug, Vowst, against C. difficile infections has spearheaded the interest in microbiome-based therapeutics. 


The recent development of microbiome-based therapeutics may have contributed to a rising trend of reclassifying microbiome probiotics as pharmaceuticals. The European Union (EU) is witnessing significant progress in the reclassification of vaginal probiotics as pharmaceutical drugs. 


The Spanish Medicines Agency (AEMPS) recently granted authorization for the country’s first-ever drug based on live microorganisms for vaginal application. Muvagyn®, a product of Casen Recordati laboratories harbor live L. gasseri and L. rhamnosus. 


The two Lactobacillus species present in the drug has been approved for recovering the altered vaginal microbiota post-antibiotic treatment of bacterial vaginosis. Moreover, its approval grants its usage for maintaining a healthy vaginal microbiota in cases of recurrent vaginal infections, too. This achievement marks a successful transition for Muvagyn®, which was previously categorized as a medical device and paves the way for other microbiome probiotics.


Germany also underwent a similar reclassification process in 2022 when the product, known as Vagisan ProbioFlora® of Dr. Wolff Group, obtained drug status. These two exapmles of vaginal probiotics that previously existed in the market marks a transition from probiotics status to therapeutical status. 


Nonetheless, they were subject to regulatory discrepancies, with some marketed as drugs and others registered as medical devices. 


This inconsistency led to disputes between companies and even between different EU national authorities and branding of many live-microbe probiotics. The situation of live-microbe probiotics was addressed by the Court of Justice of the European Union, prompting an update in the regulatory framework for medical devices throughout Europe.


The recent developments in Spain and Germany bring much-needed relief to companies in the field of vaginal probiotics and the broader microbiome-based drug industry. Previously, the lack of clear regulatory pathways for these products posed a significant challenge. 


The inconsistent categorization of vaginal probiotics as either drugs or medical devices created ambiguity in the market, leading to uncertainties for manufacturers and developers. Beyond the EU, but in the Europe, Switzerland approved Softigyn®, a vaginal product containing L. plantarum, in 2022. 


The Swiss authorities based their approval on the existence of a medicinal product with the same active substance that had been available in Italy for over 10 years. This decision also highlights the growing trend of reclassifying vaginal probiotics as valuable therapeutic options.


The reclassification of vaginal probiotics as drugs in Spain, Germany and Siwtzerland signals a positive shift in the microbiome therapeutics regulatory landscape. It establishes a clear path to market for these products and provides guidance to companies developing microbiome-based drugs. 


The harmonization of regulations across the EU ensures a level playing field and facilitates innovation in this sector. In conclusion, the reclassification of vaginal probiotics as pharmaceutical drugs in the EU, along with Switzerland’s approval, represents a significant step forward in recognizing the therapeutic potential of these products.


The positive impact of these developments extends beyond vaginal probiotics, fostering innovation and benefiting the broader microbiome-fueled pharmaceutical industry, as well.

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Barış Özdinç

Barış Özdinç analyzes microbiome research with his educational background in genetics and evolution. As a research analyst for CosmosID, he combines metagenomics and data analyses to identify microbial biomarkers in disease cohorts and evaluate microbiome research tools. His work involves curating microbiome data and creating interesting microbiome content for newsletters and blog posts. Barış Özdinç received his bachelor’s degree in genetics and master’s degree in biodiversity, evolution, and conservation from University College London (UCL). Currently, he lives in Istanbul, Turkey, where he lives with his cat, Delight, and mentors female students in their STEM career pursuits.