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Page: List of medicines under additional monitoring-2026/3/25
2026-03-26查看详情 > -
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC-2026/4/29
2026-04-30查看详情 > -
Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements for production environment
2026-06-15查看详情 > -
Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry (Final)-2022/10/5
2022-11-15查看详情 > -
Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs-2023/4/12
2023-04-13查看详情 > -
《国家药监局关于无参比制剂品种仿制研究的公告》政策解读-2023/10/13
2023-10-13查看详情 > -
Document: Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs-2025/1/8
2025-01-09查看详情 > -
Document: QRD veterinary product-information template version 9.1-2025/2/14
2025-02-18查看详情 > -
Page: Pre-authorisation guidance-2025/3/25
2025-03-26查看详情 > -
Page: Measles-2025/4/28
2025-04-29查看详情 >
