EFPIA:2025年通过依赖解锁效率-解读欧洲药品管理局的上市后授权框架报告(英文版).pdf |
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• Framework for transparency is embedded in EU legislation. • EMA publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through our evaluation of authorisation applications, RMPs, post-authorisation changes, safety reviews and withdrawals. • This guidance helps stakeholders know what kind of publications to expect on medicines undergoing evaluations and many other regulatory procedures. • This transparency enables many reg
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