The microbiome is an emerging field with huge opportunities for the development of new probiotic products, but also many regulatory challenges to face. In fact, in Europe, the existing rules regulate drugs or food supplements without providing specific indications for probiotics, which are “live biotherapeutic products” and fall halfway between these two categories.
In this context, planning a roadmap for the developement of probiotics is essential: a company that doesn’t follow an optimal workflow, especially at the beginning, risks to compromise the launch and the future development of its product.
We discussed this major issue with Clara Desvignes, Senior Regulatory Scientist of Voisin Consulting Life Sciences (VCLS).