全球药物警戒报告：五大主要监管机构不良事件义务的比较分析。
PMID：42180407 ·
C, a, r, l, o, s, , G, , B, e, r, n, a, u, s, ;, , M, a, r, i, a, , L, i, l, i, a, , B, o, u, r, n, i, s, s, e, n
广告
期刊Frontiers in drug safety and regulation
年份
PMID42180407
摘要
As pharmaceutical development spans multiple continents, marketing authorization holders must simultaneously comply with distinct adverse event reporting frameworks of major health authorities. Although International Council for Harmonisation guidelines provide shared foundations, meaningful differences persist in reporting timelines, case thresholds, and special-situation obligations across jurisdictions. A narrative review of primary regulatory legislation, guidance documents, peer-reviewed li
广告
官方来源
在 PubMed 上查看 →数据来自 PubMed / NCBI。有关全文和最新信息，请始终参阅官方记录。