Microbiome-based products, such as Live Biotherapeutic Products (LBPs) are very innovative, therefore associated with many challenges. Navigating the complex regulatory pathway is one of these major considerations. They can fall under several regulatory statuses, in both the food and medical arenas. Their intended use, target population, presentation form, composition, mode of action and route of administration will be key in determining the corresponding status.
In this “Ask the Experts” session, our experts answered questions related to microbiome product development within the European regulatory framework, from early product positioning, clinical development to regulatory implementation, such as:
- Which agencies are more experienced with development of LBPs?
- Are there any regulatory limitations to incorporate bacteria in a medical device cream?
- Which end points can be used to evaluate the impact of a product on patients’ microbiome?