EFPIA:2025年欧洲准入壁垒门户:第三份外部报告摘要报告(英文版).pdf |
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Of all new products approved by international regulators between January 2021 and June 2024, EMA approval came later, on average, than the US and by Japan by 252 days and 24 days respectively; this represents the comparative speed of EMA approvals improving since the 2024 report o For oncology drugs, EMA approval happened, on average, 69 days earlier than in Japan and 303 days later than in the US. This represents a positive trend versus 2024, where EMA approval came 204 days after PMDA o For
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