Recent scientific and technical developments create novel opportunities for
; vaccine development. Regulatory compliance has to be ensured from preclinical
; research to market authorization, whereby different legal frameworks that go
; beyond quality, efficacy or patient safety aspects need to be taken into account.
; As academia and start-ups are often focused on gathering scientific evidence,
; the regulatory maze is often regarded by applicants as challenging in the overall
; pathway to clinical translation. This is particularly true for applications concerning
; vaccine candidates containing or consisting of genetically modified organisms
; (GMOs). Active communication between applicants and competent authorities or
; advisory bodies early in the development stages facilitates a correct implementation
; of the regulatory frameworks and is of utmost importance to identify challenges
; or hurdles in order to avoid unnecessary delay in scientific review. Based on the
; state-of-play in Belgium, this chapter discusses examples of regulatory journeys of
; applications with genetically modified viral vectors and novel vaccine candidates
; that have been reviewed by GMO national competent authorities in Belgium and in
; Europe. They highlight the need of having a comprehensive view of global perspectives
; early in the development to facilitate the translation of research to clinical
; development or even market authorization.