약학회지

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Table. 2.

Table. 2. Overview of expedited programs in FDA or EMA. The main objective of each program is provided in Description
Agency Program Description
FDA Fast Track To streamline drug development and review to address serious conditions and unmet medical needs
Breakthrough Therapy To accelerate the development and review of drugs showing potential for substantial improvement over current therapies in treating serious conditions, based on preliminary clinical evidence
Accelerated Approval To enable earlier approval of drugs for serious conditions addressing unmet medical needs via surrogate endpoints
Priority Review To prioritize resources for evaluating applications for drugs with significant improvements in treating serious conditions compared to standard ones, taking action on an application within 6 months
EMA Marketing Authorization Exceptional Circumstance To grant medicines when comprehensive efficacy and safety data are lacking due to rare conditions or ethical limitations.
PRIME To boost support for medicines targeting unmet medical needs through enhanced interaction and early dialogue with developers.
Accelerated Assessment To shorten the EMA's Committee for Medicinal Products for Human Use review timeframe for marketing-authorisation applications.
Conditional Approval To grant conditional marketing authorization for such medicines with limited clinical data, prioritizing immediate availability over the need for additional data.
Yakhak Hoeji 2023;67:342-53 https://doi.org/10.17480/psk.2023.67.6.342
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