Control of therapeutic goods produced by recombinant DNA technology.

The Therapeutics Division of the Commonwealth Department of Health is responsible for ensuring the quality, safety, and efficacy of rDNA products intended for human therapeutic use in Australia. The National Biological Standards Laboratory evaluates information on production and quality control submitted by manufacturers, and the Drug Evaluation Section examines the clinical safety and efficacy aspects of product applications. rDNA production methods are considered to be biological processes requiring control of source materials, production methods, and final product for adequate quality assurance of products. The Department has recently prepared guidelines on appropriate methods of manufacture and testing of rDNA products and the requirements for product applications. The guidelines emphasize several areas of particular regulatory concern with rDNA derived products, including non-identity with the equivalent natural protein and contamination with host cell components.