HM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)

HM8

Many regions and countries have regulatory frameworks that can be applied to potentially bring medicines to patients in an expedited way, for example, fast track and breakthrough designations in the US and the accelerated assessment or PRIME designation in the EU. Usually, such mechanisms are applied to address unmet medical needs for serious or life-threatening diseases or conditions, and bring several benefits such as, expedited development and review, rolling reviews or intensive guidance during development.

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