Luis Gosalbez
Biopolis S.L.
Spain
Title: Key regulatory issues in the development of pharmabiotics in Europe
Biography
Biography: Luis Gosalbez
Abstract
Microorganisms as drugs are not regulated consistently among EU Member States, which makes investment in R&D too risky for companies. Both the industry and regulators are interested in working on legislation together in order to enable developments in this area. Pharmabiotics / Live Biotherapeutic Products are a novel regulatory category in the European pharmaceutical landscape. Challenges in terms of the scope of the regulation, safety and efficacy standards are amongst the most important to be dealt with in these early discussions.