Advanced Therapy Medicinal Products (ATMPs) are an innovative type of medicines for human use, based on genes, cells or tissues. The multiplicity of clinical studies involving ATMPs and more especially GMO products has brought us to focus on the specific requirements for these type of clinical trials.
The aim of this article is to synthesize the European regulation of the ATMPs and particularly to discuss some of the European national specific procedures for clinical trials with Genetically Modified Organisms (GMOs). Because the use of GMOs in clinical trials falls under two directives in Europe, national implementation has led to a lot of differences between the European countries regarding regulatory framework, and administrative requirements for clinical trials with GMOs.
Key learning objectives :
Define the GMO frameworks “contained use” and “deliberate release” and understand the specific requirements resulting from it.
Provide an overview of the national regulatory framework in France, Germany, Italy and United Kingdom.
Emphasize the differences to open the discussion on the harmonization of the ATMP’s regulation among EU countries.
Marie MICHEL, Senior Regulatory Scientist, Regulatory clinical trials
Elena GUEUDAR DELAHAYE, Regulatory Scientist, Regulatory clinical trials
Narayanan GOPALAN, Vice-President, Disruptive Biologics
Emmanuelle Sabbah-Petrover, Director, Complex Biologics