浙江：监管改革“破”发展堵点 药品产业“迸”创新活力

Core Viewpoint - The innovation in the pharmaceutical industry is a long and challenging process that brings significant returns for patients and societal development, with Zhejiang province focusing on regulatory reforms to enhance high-quality development in the sector [1]. Policy Empowerment: Releasing Financial Benefits - Regulatory reforms in Zhejiang aim to reduce institutional transaction costs for enterprises, thereby alleviating development burdens and broadening growth prospects [3]. - From January to September 2025, the biopharmaceutical and medical device industry cluster in Zhejiang achieved a revenue of 236.43 billion yuan and a total profit of 30.52 billion yuan, with a profit growth of 4.4% year-on-year, ranking second in profit margin among 12 industry clusters in the province [3]. - The implementation of significant policies, such as the "14th Five-Year Plan" and the "35 Drug Policies," has created a comprehensive policy ecosystem for innovation [3]. Continuous Release of Benefits in Reform Areas - Reforms have led to a 77% acceleration in the review time for supplementary applications, a nearly 30% reduction in provincial enterprise inspections, and over 90% paperless administrative approval rates [4]. - Various pilot reforms, including optimized review and approval processes for drug applications and production licenses, have accelerated innovation in Zhejiang's pharmaceutical companies [4]. Service Support: Streamlining Result Transformation - The Zhejiang Provincial Drug Administration provides comprehensive support to companies in the innovation process, facilitating communication and problem-solving [7]. - During the "14th Five-Year Plan" period, Zhejiang approved 22 innovative drugs and achieved breakthroughs in traditional Chinese medicine [7]. Technical Support: Establishing a Comprehensive Network - Zhejiang has established six municipal and county-level pharmaceutical innovation and review service institutions, along with 32 flexible review service stations, creating a technical support network across the province [9]. - The Zhejiang Provincial Food and Drug Inspection Research Institute has set up drug registration inspection laboratories, speeding up registration inspection timelines by 50% [9]. Localized Support for Enterprises - Local service centers are effectively addressing the needs of enterprises by integrating resources for registration consultation and review guidance, significantly increasing the number of drug registration checks since 2025 [10]. - The Zhejiang Drug Administration is committed to continuous regulatory reforms to ensure the pharmaceutical industry becomes a key driver of high-quality development in the province [10].