全国首个医疗机构制剂产业政策推出 打造生物医药创新“超级节点”

Core Viewpoint - The Guangdong Province has launched a comprehensive policy to support the high-quality development of the medical institution preparation industry, marking the first specialized policy in the nation for this sector [1][2] Group 1: Policy Implementation - The policy is part of the implementation of the national comprehensive reform demonstration zone for traditional Chinese medicine, aiming to leverage Guangzhou's medical resource advantages and establish a biopharmaceutical innovation "super node" [1] - The initiative is designed to enhance the collaborative development of the preparation industry across the province by utilizing Guangzhou's strengths in medical resources, industrial foundation, and market scale [1] Group 2: Challenges in the Industry - The medical institution preparation industry faces multiple obstacles, including low automation levels in production, insufficient detection accuracy, and reliance on manual operations that can lead to contamination [1] - Regulatory challenges arise from limited resources that hinder comprehensive sampling inspections and an incomplete adverse reaction monitoring system [1] - Cost issues are exacerbated by significant increases in the prices of traditional Chinese medicinal materials, while the pricing of preparations is restricted, leading to "price inversion" that halts some product varieties [1] Group 3: Specific Measures - The new policy includes 19 specific measures across five key areas: accelerating R&D transformation, restructuring the manufacturing system, expanding resource capacity, enhancing service levels, and cultivating a financial ecosystem [2] - This framework aims to provide a model for Guangdong to pioneer and test innovative practices in the medical preparation industry [2]