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Regulatory Convergence and Global Trends in Expedited Regulatory Pathways

Regulators in both established and maturing agencies are facing challenges in their effort to provide faster access to medicines to patients that need them.

In the US, companies have regularly been using available expedited pathways such as priority review, breakthrough designation, and fast track for many years.

The US Food and Drug Administration (FDA) regulatory advances have an impact outside the US, showing a wide readjustment of priorities in the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.

This effect has also been emulated in other agencies such as Health Canada, China FDA, and Korea MFDS with their recent establishment of pathways to accelerate the review of certain types of products or to establish conditional approval based on a more limited clinical data package.

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