Chapter 13 - Institutional Biosafety Committees and Regulation of Genetically Modified Organisms

Abstract

Many biotechnology products are made from or are themselves genetically modified (engineered) organisms (GMOs), which have been generated by recombinant DNA technology. Therefore, many of them are subject to an additional regulatory process beyond that of National Regulatory Authorities (NRAs) for medicines. This additional regulatory oversight varies by country. In Europe, all biotech medicines go through the centralized procedure of the European Medicines Agency (EMA). In the United States, gene therapies or gene transfer products being studied in human clinical trials may be regulated by the Recombinant DNA Advisory Committee of the U.S. National Institutes of Health, as well as the U.S. FDA. In addition to ethics committees with oversight of clinical trials, recombinant DNA technology research is overseen by Institutional Biosafety Committees (IBCs). Many countries have separate agencies (from the NRA) responsible for regulation of GMOs. Hence, regulation of biotechnological medicines may have a separate and parallel regulatory process to that of other medicines.