抗癌药多国同步获批！造福全球病患的Orbis计划又有俩国家加入(2)

2020-04-27  未知 admin

ACSS协作体成立于2017年，成员包括TGA、Health Canada、新加坡卫生科学局（Health Science Agency）与瑞士药品管理局（Swissmedic）。该协作体旨在通过工作分享机制（work-sharing），促进监管机构之间的监管合作和协同增效，解决医疗产品相关的新兴科学与监管问题。

如果Orbis计划成功扩容，将有望实现癌症用药申请在美国、澳大利亚、加拿大、新加坡、瑞士的同步获批，也有利于不同国家药品监管机构间的交流、互动。

参考文献：

[1] FDA. Project Orbis. Sept 17, 2019. Retrieved Nov 14, 2019 from https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

[2] FDA. FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma. Sept 17, 2019. Retrieved Nov 14, 2019 from https://www.fda.gov/news-events/press-announcements/fda-takes-first-action-under-new-international-collaboration-australia-and-canada-designed-provide

[3] TGA. Australia-Canada-Singapore-Switzerland (ACSS) Consortium. Retrieved Nov 14, 2019 from https://www.tga.gov.au/australia-canada-singapore-switzerland-acss-consortium

[4] TGA. International work-sharing pilot - Apalutamide (Erlyand). July 5, 2018. Retrieved Nov 14, 2019 from https://www.tga.gov.au/media-release/international-work-sharing-pilot-apalutamide-erlyand

[5] Zachary Brennan. FDA’s Project Orbis May Expand to Singapore and Switzerland. Nov 12, 2019. Retrieved Nov 14, 2019 from https://www.raps.org/news-and-articles/news-articles/2019/11/fdas-project-orbis-may-expand-to-singapore-and-sw

[6] Government of Canada. Terms of Reference. Australia, Canada, Singapore, Switzerland Consortium (ACSS Consortium). June 20, 2007. Retrieved Nov 15, 2019 from https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/head-agencies-australia-canada-singapore-switzerland-consortium-terms-of-reference.html

原标题：视点 | 抗癌药多个国家同步获批！造福全球病患的这个计划，又有两个国家要加入