China’s updated framework on the segmented manufacturing of biological products provides further regulatory clarification following the entry into force of the revised Implementing Regulations of the Drug Administration Law. The Notice refines the legal requirements governing quality management, manufacturing oversight and regulatory review, while also addressing the conditions applicable to cross-border manufacturing arrangements. These developments are of particular relevance to pharmaceutical and biotechnology companies operating in, or supplying, the Chinese market, as they may affect licensing strategies, contractual structures and ongoing compliance obligations. A careful assessment of the new regulatory framework is therefore essential to ensure alignment with the evolving requirements of Chinese pharmaceutical law. The links below provide access to a detailed legal analysis of the Notice, together with the complete official regulatory text for direct consultation