Environmental risk assessment for medicinal products containing genetically modified organisms
Anliker, B.; Longhurst, S.; Buchholz, C. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 2009 · Heft 11 · S. 52 bis 57
Bibliografische Angaben
Zusammenfassung
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…
