The European Medicines Agency's PRIME scheme to accelerate the development of promising drugs that address unmet medical needs has enrolled 19 products in its first year, showing considerable overlap with FDA breakthrough therapy designees but also key differences.
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Mullard, A. PRIME time at the EMA. Nat Rev Drug Discov 16, 226–228 (2017). https://doi.org/10.1038/nrd.2017.57
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DOI: https://doi.org/10.1038/nrd.2017.57
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Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019
International Journal of Clinical Pharmacy (2023)