不良事件报告
- IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current Annexes and Appendix release: IMDRF/AE WG/N43FINAL:2025 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
- IMDRF/AET WG/N85 FINAL: 2024 Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators