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【奥译言】澳大利亚政府接受建议:为医疗器械建立多个上市批准途径

阅读: 2016年09月19日


要点概述:


  • 澳大利亚卫生部已经接受专家组的建议,为必赢亚娱乐官网申请人建立多个上市批准途径。

  • 加快审批和澳大利亚药品管理局(TGA)认可国外监管机构的上市批准包含在了这些建议之中。

  • 澳大利亚政府计划于2016年和2017年开始实施监管改革。


针对一系列新的医疗器械和药品监管改革的建议,澳大利亚政府已经表示对医疗器械的多个上市批准途径的支撑,以便有更多的新器械可供患者和用户使用。


从2014年底开始,由政府委托的专家组对澳大利亚当前的药品和医疗器械监管体系进行了评估,随后,这些建议便应运而生。澳大利亚卫生部就58条专家组的建议做出了官方回应。


为提高澳大利亚药品管理局(TGA)对医疗器械的监管,专家组提议,为那些想进入澳大利亚市场的医疗器械制造商建立三个主要的上市批准途径:

  • 第一,若想进入澳大利亚市场,注册申请人需接受澳大利亚的符合性评估,该评估由TGA或TGA指定的其它机构实行。

  • 第二,倘若注册申请人已经在其他国家接受了监管当局认可机构的符合性评估或者已经直接获得其他国家监管当局的上市批准,那么注册申请人可以使用在其他国家获得的上市批准来满足TGA的要求。

  • 第三,在某些情况下,器械可获得TGA的加快审批。


澳大利亚政府已经正式接受这些建议,并表示,实现多个上市批准途径可以“简化医疗器械的上市流程,为申请人提供更多的灵活性,并且符合政府的监管改革和可竞争性议题。”


根据澳大利亚卫生部的官方回应,澳大利亚卫生部计划于2016年和2017年针对专家组的建议开始实施监管改革。


英语原文


Australian Government Accepts Proposals for Multiple Market Pathways for Medical Devices


September 16, 2016 by Stewart Eisenhart


EMERGO SUMMARY OF KEY POINTS:


  • The Australian Department of Health has accepted expert panel recommendations to establish multiple market pathways for medical device registrants.

  • Expedited approvals and Therapeutic Goods Administration recognition of market authorizations from foreign regulators are included in the recommendations.

  • The Australian government plans to begin implementing regulatory reforms in 2016 and 2017.


Responding to a series of new medical device and pharmaceutical regulatory reform proposals, the Australian government has expressed support for more than one pathway to market authorization in order to boost patient and user access to new devices.


The proposals follow an assessment of Australia’s current drug and medical device regulatory system starting in late 2014 by a government-commissioned expert panel. The Australian Department of Health officially responded to 58 panel recommendations.


Among recommendations for improving the Therapeutic Goods Administration (TGA) oversight of medical devices, the panel proposed establishing three major market pathways for manufacturers to commercialize their products in Australia:

  • First, Australian market registrants would undergo conformity assessments in the country either by the TGA or another entity designated by the TGA to perform such assessments.

  • Second, registrants could use marketing approvals obtained in other markets to satisfy TGA requirements, provided that those registrants have either undergone conformity assessments by regulator-accredited organizations in those other markets or obtained their approvals directly from a market regulator.

  • Third, devices may obtain expedited TGA approval under certain circumstances.


The government has officially accepted these recommendations, stating that implementing multiple market pathways would “streamline access to medical devices for consumers, provide additional flexibility for sponsors, and is consistent with the Government’s regulatory reform and contestability agendas.”


The Department of Health plans to implement “early opportunities” of the expert panel’s recommendations in 2016 and 2017, according to its official response.


来自:Emergo

整理:奥咨达





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