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药你知道 | 《国家药监局关于发布优化全生命周期监管支持高端医疗器械创新发展有关举措的公告》系列解读(十)-2025/10/16
2025-10-17查看详情 > -
Page: Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)-2025/11/20
2025-11-21查看详情 > -
Page: Extensions of marketing authorisations: questions and answers-2025/12/15
2025-12-16查看详情 > -
Document: Report - Highlights of the 15th Industry Standing Group (ISG) meeting-2026/1/28
2026-01-29查看详情 > -
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection-2026/3/6
2026-03-09查看详情 > -
Document: European Medicines Agency's data protection notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme-2026/4/7
2026-04-08查看详情 > -
Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 4-6 May 2026-2026/5/20
2026-05-21查看详情 > -
Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)-2022/12/16
2022-12-19查看详情 > -
Final Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements-2023/6/27
2023-06-28查看详情 > -
Final Guidance: Rare Diseases: Considerations for the Development of Drugs and Biological Products-2023/12/22
2024-01-03查看详情 >