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关于公开征求《药物临床试验方案审评工作规范(征求意见稿)》意见的通知-2022/10/27
2022-11-14查看详情 > -
国家药监局关于发布化学仿制药参比制剂调整程序的公告(2023年第35号)-2023/03/24
2023-03-24查看详情 > -
Final Guidance: Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”-2023/9/29
2023-10-07查看详情 > -
Document: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products-2025/1/7
2025-01-08查看详情 > -
Page: Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance-2025/2/12
2025-02-13查看详情 > -
Document: Release notes - production release version 1.7.2514-3 - 21 March 2025 - Veterinary Medical Products Regulation: Union Product Database-2025/3/21
2025-03-24查看详情 > -
Document: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)-2025/4/22
2025-04-23查看详情 > -
Document: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2-2025/6/4
2025-06-05查看详情 > -
Document: Annex II questions and answers – Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal products-2025/7/10
2025-07-11查看详情 > -
Document: QRD PSUR annex IV template-2025/8/18
2025-08-19查看详情 >