Regulatory aspects and approval of biopharmaceuticals for mucosal delivery: Quality, toxicology, and clinical aspects

Abstract

Regulation of products for mucosal application has many points in common with products for other routes but also some that are unique. Identifying regulatory pitfalls is of tremendous importance early in development as this saves time, money, and nerves. There is a huge amount of regulatory advice available from the different players in the field (governments and related organizations) that is partly very general or exceptionally specific. This chapter is meant to provide guidance on what to find, where and who to ask if certain questions arise. It also provides a description of common and known problems differentiated by the three major parts: quality, preclinical, and clinical development. Finally, special key points focusing on pediatric use, use of genetically modified organisms or products classified as advanced therapy medicinal products are discussed.