A comparative analysis of regulatory policies of ICH Q12 for post-approval chemical, manufacture and control changes of chemical drugs in China and Europe

ZHANG Hui-lan, HUANG Zhe

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Chinese Journal of New Drugs ›› 2026, Vol. 35 ›› Issue (16) : 1689-1693. DOI: 10.20251/j.cnki.1003-3734.2026.16.002

A comparative analysis of regulatory policies of ICH Q12 for post-approval chemical, manufacture and control changes of chemical drugs in China and Europe

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{{article.zuoZheEn_L}}. {{article.title_en}}. {{journal.qiKanMingCheng_EN}}. 2026, 35(16): 1689-1693 https://doi.org/10.20251/j.cnki.1003-3734.2026.16.002

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