*题图来自网络,仅作示意用。 世界卫生组织(WHO)于5月份更新了“WHO eCTD 门户和指南”页面,并宣告其药品预认证(Prequalification,PQT)将全面引入eCTD提交机制。 WHO实施时间表:2025自愿,2026强制,2027全面转换 WHO为eCTD的全面实施制定了详细的过渡时间表。
All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...
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