关键词: 生物制品, 分段生产, 监管政策, 试点探索

Abstract:

Under the background of rapid development in the biomedical industry and strong support from national policies， the segmented production model for biological products in China has gradually emerged as a critical pathway to overcome industry bottlenecks and optimize resource allocation. This study systematically reviews the evolution of China's regulatory policies for the segmented production of biological products， elucidating the logic of the institutional transition from "prohibiting contract manufacturing" to "pilot exploration." However， risks such as cross-regional coordination， responsibility tracing， and cold chain logistics continue to constrain industry development. Guangdong province， through proactive services， facilitated the segmented production pilot project for pharmaceutical enterprises in the province， significantly expediting drug registration， approval， and the commencement of commercial production. This study analyze， the background of segmented production for biological products and the risks and challenges encountered during the implementation of its regulatory policies， reviews the development process of China's regulatory policies on the segmented production of biological products， summarize， the pilot implementation and outcomes in Guangdong province. Furthermore， it proposes recommendations focusing on three key aspects： the quality management system， product technology，and communication and coordination.Additionally， based on current regulatory practices， the study offers insights on key issues related to digital applications， tiered supervison， dynamic risk control， and cross-border collaboration so as to provide valuable experience for the comprehensive nationwide promotion of this model.

Key words:  , Biologics； , Segmented production； , Regulatory policies； , Pilot exploration