提高ICH《E6:药物临床试验质量管理规范》(GCP)是涉及人类参与者的临床试验的国际性伦理和科学质量标准。遵循 GCP 开展临床试验将有助于确保试验参与者的权益、安全和健康得到保护,并且确保临床试验结果可靠。GCP 是各国药品监管部门对药物临床试验监督 ...
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...
In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15 November 2018 also was informed of progress made on a ...
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma ...