【奥译言】澳大利亚扩大医疗器械申请中可接受外国监管机构的范围

2018-08-23 09:59 阅读数：4279 标签：

2018年8月21日 Ana Mulero

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从本月起，澳大利亚治疗用品管理局（TGA）将扩大其在医疗器械申请方面可接受的国际评估和批准的范围。

本周一，TGA表示，具有可比性的国外监管机构（COR）的数量将不再只包括欧盟公告机构，也将会包括美国食品药品监督管理局（FDA），加拿大卫生部，受医疗器械单一审核程序管辖的审计机构，以及日本厚生省及其药品医疗器械机构。

这一决定是TGA对澳大利亚政府之前基于对其药品和医疗器械管理条例的评估，要求加强对某些国外市场批准上市的医疗器械的使用所提出的建议而做出的回应。

作为该决定的一部分，TGA本周一发布了新的指导原则，以帮助适用的企业缩小此前已获得的海外评估和批准和纳入澳大利亚治疗用品注册（ARTG）之前的差距。

指导原则中明确了TGA接纳国外文件，包括FDA的决定和加拿大卫生部的批准和许可，作为其自身评估的证据的要求。例如，提交的文件应是关于同一器械且为相同的预期目的和适应症所设计。

该监管机构表示:“这将使TGA减少必须按照特殊申请来进行的评估数量。”

此前，该监管机构已经在6月份的时候，在药品申请的工作分工上，执行了一种新的COR程序。

英文原文

Australia Expands Range of Acceptable ForeignRegulators for Device Applications

Posted 21August 2018 | By Ana Mulero

Beginningthis month, Australia’s Therapeutic Goods Administration (TGA) will expand itsrange of acceptable international assessments and approvals on medical deviceapplications.

TGA saidMonday the number of comparable overseas regulators (COR) will start to includenot just EU notified bodies, but also the US Food and Drug Administration(FDA), Health Canada, auditing organizations under the Medical Device SingleAudit Program, as well as Japan’s Ministry of Health, Labour and Welfare andits Pharmaceutical and Medical Devices Agency.

The decisioncomes as TGA’s response to a previous recommendation from the Australiangovernment, which was based on its review of the medicines and medical devicesregulation, for the regulator to enhance its use of certain marketing approvalsfor devices in foreign markets.

As part ofthe decision, TGA released new guidance on Monday to aid industry in bridgingthe gap between previously obtained overseas assessments and approvals and theinclusion of medical devices in the Australian Register of Therapeutic Goods(ARTG) as applicable.

The guidancedocument sets forth the requirements for TGA to take into considerationoverseas documentation, including on FDA decisions and Health Canada approvalsand licenses, as evidence for its own assessments. For example, the proposeddocumentation should be on the same device and design for the same intendedpurpose and indications.

“This will result inthe TGA being able to reduce the amount of assessment that it must undertake ona particular application,” the regulator said.

Theregulator implemented a new COR process for work-sharing on drug applicationsin June.

A separatenotice posted by TGA on Monday provides additional guidance on applicationsrequirements for medical devices to pass preliminary assessments for inclusionin the ARTG.

内容来自：RegulatoryAffairs Professionals Society (RAPS)