2025年中国中硼硅玻璃关联评审现状 “A”类评审结果占优【组图】
Qian Zhan Wang·2025-08-12 09:27

Core Insights - The revised Drug Administration Law in China mandates that the State Council's drug supervision department reviews chemical raw materials, excipients, and packaging materials together with drug approvals, ensuring comprehensive quality standards and production processes are evaluated [1] Group 1: Review Process - The new law specifies that the approval process for drugs will include a joint review of raw materials, excipients, and packaging materials [1] - The registration platform will now indicate two types of review results: "A" for approved materials and "I" for those not yet approved [1] Group 2: Review Results Distribution - As of 2025, the distribution of review results for Chinese borosilicate glass packaging shows that "A" class results total 239, accounting for 47%, while "I" class results account for 53% [2] - In the "A" class results, there are 164 domestic products and 75 imported products, while the "I" class results include 203 domestic and 65 imported products [4] Group 3: Product Categories - The "A" class results for injection bottles show a significant number, with 116 for injection bottles, 77 for ampoules, 3 for infusion bottles, and 43 for others [4] - Conversely, the "I" class results for injection bottles are also substantial, with 164 for injection bottles, 85 for ampoules, 14 for infusion bottles, and 5 for others [7]

2025年中国中硼硅玻璃关联评审现状 “A”类评审结果占优【组图】 - Reportify