Environmental risk assessment of advanced therapies containing
genetically modified organisms in the EU
Abstract
Gene therapy medicinal products have the potential to provide curative
treatment to many diseases with current limited therapeutic options. As
advanced therapy medicinal products (ATMPs), these therapies undergo a
centralised, single European Union authorisation by the European
Medicines Agency, but the risks, and potential harm to the environment
and population at large are weighted in each application, and different
interpretations at national level exist. A streamlined procedure is now
in place to facilitate a consistent approach for the assessment of the
environmental risks of medicines containing genetically modified
organisms. This article provides an overview of basic requirements
across the EU, an overview of the new streamlined process and discusses
available guidance for developers. All these initiatives are aimed to
remove hurdles for ATMP developers and facilitate faster access to
patients.