Product Registration and Regulatory Change

Abstract

The enactment of the FDA Good Laboratory Practices (GLPs) into law by the FDA has led to major changes throughout industrial toxicology programs. One major addition to toxicology studies, as specified in the GLPs, includes the requirement of a quality assurance (QA) program. Initially, the role of QA was that of monitor or auditor. This role has expanded in a practical sense, however, to include a working knowledge of regulatory affairs and principles of toxicology. Since 1978, new GLPs and test standards have been issued by several countries, including the United States. The requirements and guidelines set forth by various countries, while similar in content, are different in their specific details. The development of comprehensive, scientifically sound protocols to meet these new requirements necessitates a continual assessment of the regulations in effect in the countries where registration is sought. Thus, the role of QA has expanded to include the assessment of guidelines and protocols to assure that toxicology studies conducted to support registration are in compliance with these guidelines. © 1984, SAGE Publications. All rights reserved.