Clinical trials (CTs) with investigational medicinal products (IMPs) that contain or consist of genetically modified organism(s) (GMO-IMPs) have significantly increased in Europe over the past few years.
Initiation of such CTs should comply with both CT and GMO regulatory frameworks and requires applications to various competent authorities (CAs). Coordinating these submissions, considering the heterogeneity of national GMO requirements, as well as selecting sites, are part of the numerous challenges faced by sponsors when seeking authorisation for the use of GMO-IMPs within CTs.
In this article, an overview is provided on the articulation between CAs involved under each framework in a selection of EU countries, as well as on new challenges inherent in the new EU CT Regulation (No 536/2014) on the CTs involving GMO-IMPs.
In addition, the recently published EU harmonised GMO requirements, and national considerations for compiling a biosafety dossier in the frame of CTs are discussed.
Finally, an insight is given on the implementation of the GMO regulatory framework at clinical sites.