Current International Harmonization Efforts

Abstract

Efforts towards international cooperation or harmonization can occur at varying levels – at the level of technical and scientific requirements, of dossier format and content, or of assessment and review practices. Three contrasting models for regional cooperation in drug regulation harmonization, the corporate , populist , and cooperative , are described and compared. Utilizing a specific case, drug stability testing requirements in Climatic Zone IV, the author explores each organizational model in action, reviews recent history of a key stability debate among harmonization initiatives from different climatic zones, discusses benefits and disadvantages seen in organizational models, and proposes the best practices approach to global harmonization efforts for the future.