香港药剂业及毒药管理局辖下的药剂业及毒药委员会于周五宣布,已有条件批准瑞德西韦的药物注册,注册证书持有人为美国药厂吉利德科学公司(Gilead Sciences)。卫生署药物办公室会负责向管理局及其委员会提供专业和行政支援。
为了加快新冠肺炎药物的注册批准,药剂业及毒药委员会召开特别会议,以评估相关申请。委员会认为,虽然目前关于瑞德西韦治疗新冠肺炎的功效及安全性数据有限,但基于现时公共卫生紧急事态、当地的医疗需要、以及现时没有其他已注册为治疗新型冠状病毒的药物,认为使用瑞德西韦的效益大于风险,故有条件地批准相关注册申请。
在有条件批准注册下,吉利德需要按规定,通过正在进行的临床研究和上市后报告(post-marketing report),向卫生署药品办公室提交更多有关安全性,功效和质量的数据。
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