Comparison of Additional Regulatory Requirements for Conducting Clinical Trials on Genetically-Modified Microorganisms a
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
COMPARISON OF ADDITIONAL REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS ON GENETICALLY-MODIFIED MICROORGANISMS AND RECOMBINANT DNA IN EUROPE, THE UNITED STATES, AND CANADA KINGC. LEE,PHD, RAC Won Pharmaceuticals, Inc., New Haven, Connecticut
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. Key Words: Genetically-modified organisms; D N A ; Clinical trials; Europe;United States; and Canada
INTRODUCTION THE USE OF GENETICALLY-modified organisms (GMOs), DNA, gene therapy, and therapies directly and indirectly associated with gene modifications is on the horizon. Numerous pharmaceutical and biotechnology companies are at various stages in the development of these novel therapies, which
Reprint address: King C. Lee. PhD. Aton Pharma. Inc., 777 Old Saw Mill fiver Rd., Suite 205, ~ q NY 10591. E-mail: [email protected].
have potential applications for a variety of diseases, including cancer, metabolic diseases, cardiovascular diseases, pulmonary diseases, and so forth. Accordingly, the number of clinical trials related to GMOs and recombinant DNA undoubtedly 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 GMOs and recombinant DNA that are in addition those required for ~ to~ ~ , the traditional small molecules or biologics. It is not the
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intent of this article to provide detailed regulatory requirements for conducting clinical studies of.GMOs, gene therapy products, and recombinant DNA. Readers should refer to the specific guidelines from the regulatory bodies for specific guidance.
EXTRA REGULATORY REQUIREMENTS FOR CLINICAL STUDIES OF GMOs IN EUROPE, WHEN COMPARED TO TRADITIONAL SMALL MOLECULES AND BIOLOGICS The term GMOs is used by the European regulatory bodies. According to European regulatory bodies, GMOs are organisms that have been genetically modified through one
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