新西兰药品安全局首次经「二元规则」快速通道批准药物：帕利哌酮获批
新西兰卫生副部长 David Seymour 2026年11月12日在惠灵顿宣布，精神分裂症治疗药物帕利哌酮（Paliperidone）成为首个经新西兰「二元规则」（Rule of Two）快速通道获批的药物，批准由新西兰药品安全局 Medsafe 作出。
「二元规则」是新西兰的加速审批路径设计：已获两个受认可海外监管机构批准的药物，可在新西兰走简化评估，以缩短新药进入本国市场的时间。帕利哌酮是这条通道启用后的首个获批品种。
Seymour 分管卫生事务，他在政府发布的声明中公布了这一首例批准。新西兰政府的卫生发布平台 Beehive 当日刊出该消息。（来源：新西兰政府）
New Zealand's Medsafe Approves First Medicine via Rule of Two Pathway: Paliperidone
New Zealand Associate Health Minister David Seymour announced in Wellington on November 12, 2026, that paliperidone has become the first medicine approved in New Zealand via the expedited Rule of Two pathway, with the approval granted by Medsafe, the country's medicines regulator.
The Rule of Two is an accelerated approval route under which medicines already approved by two recognised overseas regulators can undergo a streamlined assessment in New Zealand, shortening the time for new medicines to reach the local market. Paliperidone, a treatment for schizophrenia, is the first approval under the pathway.
Seymour, the Associate Minister of Health, announced the first approval in a government release published on the Beehive platform the same day. (Source: New Zealand Government)
来源：新西兰政府
发布：GSM·美国（发布链接）
图片来源：图：新西兰议会大厦（惠灵顿）。照片：Tom Ackroyd，CC BY-SA 4.0，经 Wikimedia Commons。 / New Zealand Parliament Buildings in Wellington. Photo by Tom Ackroyd, CC BY-SA 4.0, via Wikimedia Commons.
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