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他达拉非片生物等效性研究技术指导原则-2022/11/25
2022-11-25查看详情 > -
国家药监局综合司再次征求《药品标准管理办法（征求意见稿）》意见-2023/5/5
2023-05-06查看详情 > -
Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)-2023/11/13
2023-11-15查看详情 > -
Document: PRAC work plan 2025-2025/1/16
2025-01-17查看详情 > -
Document: DARWIN EU data partners onboarded in phases I, II and III-2025/2/20
2025-02-21查看详情 > -
Document: List of centrally authorised products with safety-related changes to the product information-2025/3/31
2025-04-01查看详情 > -
Document: Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status-2025/5/6
2025-05-07查看详情 > -
Page: Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations - Scientific guideline-2025/6/16
2025-06-17查看详情 > -
Document: Highlights from the 13th meeting of the Nitrosamine Implementation Oversight Group (NIOG)-2025/7/21
2025-07-22查看详情 > -
Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)-2025/9/4
2025-09-05查看详情 >
