重磅！2025年中国及31省市中硼硅玻璃行业政策汇总及解读（全）

Core Insights - The article outlines the evolution of policies in China's borosilicate glass industry, emphasizing a clear trajectory from standard establishment to regulatory enhancement, domestic substitution, and innovation upgrades [1][3]. National Policy Summary and Interpretation - Recent years have seen increased emphasis on the quality and selection of pharmaceutical packaging materials and containers, with the National Medical Products Administration reiterating that the quality and performance of packaging materials for injectable drugs must meet or exceed that of reference formulations [3][4]. - The "14th Five-Year" Pharmaceutical Industry Development Plan, issued by multiple government departments, aims to establish a robust standard system and quality specifications for pharmaceutical excipients and packaging materials, facilitating compliance with consistency evaluation and internationalization requirements for formulations [3][4]. - Although the consistency evaluation policy does not mandate the use of borosilicate glass for injectable drug generics, domestic companies are inclined to adopt similar materials due to the prevalence of borosilicate glass in reference formulations used by foreign original drug manufacturers, thus promoting the domestic substitution process [3][4]. Key Development Policies and Plans (2012-2025) - A comprehensive table outlines significant policies and regulations from 2012 to 2025, detailing the publication dates, issuing bodies, and main content of each policy, which collectively support the development of the borosilicate glass industry [4][5][6]. - Policies include optimizing drug supplementary application review processes, enhancing the resilience and modernization of the pharmaceutical industry, and establishing quality management systems for pharmaceutical packaging materials [5][6]. Provincial Policy Summary and Interpretation - Various provinces have implemented policies focusing on improving the quality of pharmaceutical excipients and packaging materials, encouraging the use of new materials and technologies, and enhancing quality supervision [17][18]. - Specific initiatives include the promotion of research and development in pharmaceutical packaging materials, the introduction of advanced technologies, and the establishment of quality standards for drug packaging [18][21]. - The policies aim to support the development of the borosilicate glass industry while addressing environmental standards and promoting technological upgrades [18][21].