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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 > -
Page: EU enlargement-2025/10/7
2025-10-08查看详情 > -
Document: Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species-2025/11/14
2025-11-17查看详情 >