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Clinical Trials with GMOs in the EU – From Regulatory to Sites

Post thumbnail Clinical Trials with GMOs in the EU – From Regulatory to Sites

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.

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publication by

Elena Gueudar Delahaye thumbnail
Elena Gueudar Delahaye
Regulatory Scientist, Clinical Trials Submissions and Operations
As a Regulatory Scientist, in the Clinical Trials Submissions and Operations team Elena has responsibility for managing submission and maintenance of clinical trial applications.
Julie Liberman thumbnail
Julie Liberman
Regulatory Scientist, Clinical Trial Submission & Operations
As a Regulatory Scientist within the Clinical Trial Submission & Operations Team at VCLS, Julie has been participating for 3+ years in the regulatory project management of a variety of clinical studies, including clinical trials with gene therapy drug products.
Marie Michel thumbnail
Marie Michel
Senior Regulatory Scientist – Clinical Trial Submissions and Operations
As a Senior Regulatory Scientist within the Clinical Trial Submissions and Operations Group at VCLS, Marie is responsible for the regulatory project management of a variety of clinical studies on behalf of clients. This includes provision of strategy in the submission of clinical trial applications, especially for clinical trials with GMO drug products.