Environmental risk assessment for medicinal products containing genetically modified organisms

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
B AnlikerC J Buchholz

Abstract

Many gene therapy medicinal products and also some vaccines consist of, or contain, genetically modified organisms (GMOs), which require specific consideration in the environmental risk assessment (ERA) before marketing authorisation or clinical trial applications. The ERA is performed in order to identify the potential risks for public health and the environment, which may arise due to the clinical use of these medicinal products. If such environmental risks are identified and considered as not acceptable, the ERA should go on to propose appropriate risk management strategies capable to reduce these risks. This article will provide an overview of the legal basis and requirements for the ERA of GMO-containing medicinal products in the context of marketing authorisation in the EU and clinical trials in Germany. Furthermore, the scientific principles and methodology that generally need to be followed when preparing an ERA for GMOs are discussed.

References

Jun 1, 2005·Trends in Immunology·Marianne M Stanford, Grant McFadden
Sep 21, 2007·The Journal of Gene Medicine·Ellen A M Schenk-BraatLeonie C M Kaptein

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Citations

May 4, 2002·Toxicology Letters·Reinhard Länge, Daniel Dietrich
Jan 18, 2012·Human Gene Therapy·Christian J BuchholzSilke Schüle
Apr 17, 2015·Bioengineered·Petra ZadravecAleš Berlec
Mar 28, 2018·Radiation Oncology Journal·Jeong Il YuHee Chul Park
Aug 14, 2019·Environmental Toxicology and Chemistry·Philipp Uhl, Carsten A Brühl
Apr 14, 2021·Nature Protocols·Tatjana WeidnerChristian J Buchholz

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