Navigating drug registration in China: accelerated review policies and pathways

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Since joining the International Council for Harmonisation (ICH) in 2017, China has been committed to reforming its drug registration system to simplify application procedures and align with international standards. Despite significant progress, challenges remain. To address urgent clinical needs, China has introduced accelerated review policies and pathways for the registration of drugs for urgent clinical use, rare diseases and breakthrough therapies. This article provides an overview of the standard drug registration process in China and offers a detailed analysis of these accelerated pathways, outlining their requirements, benefits and timelines. Additionally, practical tips and strategic advice are shared to assist pharmaceutical companies in navigating these policies for faster market access in China.

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