Publication

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators


Released:

Report at a Glance

  • Report Highlights (HTML)
  • Report Recommendations (HTML)

Promoting and protecting public health was, is, and always will be central to the missions of medicines regulatory authorities. How to achieve this goal without stunting innovation at a time of unprecedented advances in drug development and supply chain complexity, however, is a major challenge for regulatory authorities worldwide. For many, the answer lies within reliance. Maximizing reliance and cooperation efforts with other trusted regulators is key to ensuring the quality, safety and efficacy of medicines in today’s globalized world.

It is within this context that the National Academies of Sciences, Engineering, and Medicine assembled an expert committee to examine the challenges and opportunities facing medicines regulatory authorities, particularly in the context of mutual recognition agreements and other forms of regulatory reliance. The resulting report, Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators, provides an overview of the landscape and presents the committee’s strategy for improving regulatory cooperation in ways that place the public’s interest at the center of its efforts.