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国家药监局关于启用《出口欧盟原料药证明文件》和《药品出口销售证明》电子证明的公告 （2022年第95号）-2022/10-31
2022-11-14查看详情 > -
国家药监局药审中心关于发布《药物临床试验期间安全性数据快速报告常见问答（2.0版）》的通告（2023年第17号）-2023/03/17
2023-03-17查看详情 > -
Final Guidance: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health -2023/9/20
2023-09-21查看详情 > -
Document: Checklist for initial notifications for parallel distribution: guidance for industry-2025/1/6
2025-01-07查看详情 > -
Document: Agenda of the PRAC meeting 10-13 February 2025-2025/2/10
2025-02-11查看详情 > -
Document: ICH M11 Technical Specification - Updated step 2b-2025/3/18
2025-03-19查看详情 > -
Document: Business process description for committee management-2025/4/22
2025-04-23查看详情 > -
Document: Organisation chart: Advisory functions-2025/6/2
2025-06-03查看详情 > -
Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications-2025/7/8
2025-07-09查看详情 > -
Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2-2025/8/8
2025-08-10查看详情 >
