Ensure full compliance for conducting clinical research with genetically-modified organisms
The EU legislation governing the authorization of clinical trials (EU CTR 536/2014) does not address environmental aspects. If a medicinal product contains or consists of a Genetically Modified Organism (GMO), there are additional requirements for the use of the product.
As defined by EUR-Lex, GMOs are organisms (apart from human beings) whose genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
Clinical trials in the EU with GMO products must comply with requirements under either the deliberate release (Directive 2001/18/EC) and/or the contained use (Directive 2009/41/EC) GMO framework. Many countries outside of the EU/EEA have similar requirements when conducting clinical trials with GMO products.
The use of GMO-containing Investigational Medicinal Products (IMPs) in clinical trials often requires separate applications to distinct national authorities, who are responsible for the environmental assessment of the IMP. Although harmonized documentation has been endorsed by several countries in the EU, there are national requirements to consider (additional forms, language requirements) which vary significantly between countries.
VCLS is able to support you with the following activities regarding your trials with GMO products:
- Identification of applicable regulatory framework(s) and country-specific submission requirements
- Draft and review of Environmental Risk Assessments and application forms
- Preparation and submission of applications to applicable authorities
- Follow up and maintenance of GMO authorization