European regulations concerning the development of Advanced Therapeutic Medicinal Products (ATMPs) are complex and provide a number of additional challenges to sponsors developing gene therapies, somatic cell therapies and tissue engineered products.
Genetically Modified Organisms (GMOs)
Gene therapies and gene modified somatic cell therapies are subject to additional regulation in relation to the manufacture and use of genetically modified organisms. The regulations to be applied depend on the member state and if use of the GMO is considered “contained use” or “deliberate release”. Table 1 illustrates how this classification can vary between member states.
Additionally, the authority responsible for GMO applications may not be the same health authority that reviews clinical trial applications (CTAs). For example in the UK two agencies, the Heath & Safety Executive (HSE) and the Dept. for Environment & Rural Affairs (DEFRA), are responsible for GMO applications considered contained use and deliberate release respectively.