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Current International Harmonization Efforts

Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

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.

Keywords

Drug Stability Cooperative Model Drug Regulatory Authority Corporate Model Harmonization Effort 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Food and Drug AdministrationCenter for Drug Evaluation and Research, International ProgramsRockvilleUSA

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