Comparison of Additional Regulatory Requirements for Conducting Clinical Trials on Genetically-Modified Microorganisms and Recombinant DNA in Europe, the United States, and Canada

Abstract

The number of clinical trials related to genetically-modified organisms and recombinant DNA will increase exponentially in the next decade. This article describes and compares the European, United States, and Canadian regulatory requirements for conducting clinical trials related to genetically-modified organisms and recombinant DNA. In Europe, the additional regulatory requirements include submissions and approvals from the local and national genetically-modified organisms safety committees, and the gene therapy committee (if applicable). If the genetically-modified organism is imported from another country, an “importer” certification is also required. In the United States, the additional regulatory requirements include review/approval by the institutional biosafety committee and the Recombinant DNA Advisory Committee. For gene therapy, additional information is required by the Food and Drug Administration. In Canada, review by the institutional biosafety committee (for biological hazards) and Canadian Institutes of Health Research (for research it funds) is required.