历期数据
HSA post-marketing vigilance guidance Version 6
HSA post-marketing vigilance guidance Version 6
记录详情
- 数值
- HSA uploaded Version 6 of the post-marketing vigilance guidance on 1 April 2026, revising scope, contact requirements, serious-adverse-event criteria, identifiable-patient examples, literature reports, lack-of-efficacy reports, clinical safety study reports and eCTD submission references
- 单位
- guidance revision
- 数值类型
- observation
- 适用人群
- Companies responsible for post-marketing surveillance of therapeutic products and CTGTP in Singapore
- 分母口径
- Guidance scope; not a marketing-authorisation decision and not a declaration that every adverse event is reportable
- 统计期间
- Version 6 uploaded 1 April 2026
- 检索日期
- 2026-09-02
- 发布日期
- 2026-04-01
- 地理范围
- sg.geo.country.singapore
日期表示本记录的统计期间与适用范围。核验日期并不代表规则目前已经生效。
资料来源
知识库资料截至 2026-10-07 · 知识库持续扩充中。发布数量表示现有内容，并不代表已覆盖新加坡的全部知识。