Current Edition

The Role of Regulatory Agencies in New Drug Development: A Global Perspective

Regulatory agencies worldwide play a critical role in healthcare as independent reviewers and approvers of applications made by sponsors to conduct clinical trials, and ultimately to market a drug for a particular indication. J. Rick Turner, Theo J. Hoofwijk, and Robin Huff of Quintiles present an overview of the regulatory landscapes for new drug development in the United States (US), Japan, and the European Union (EU); the three geographic regions that came together to form the International Conference on Harmonisation of the Technical Requirements for Registration of Pharmaceuticals for Human Use.