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99 result(s) found, displaying 1 to 25
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PageThese historical guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants in the Australian Register of Therapeutic Goods (ARTG).
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PageTGA presentation slides from Regulatory Affairs for Medical Devices Workshop, NSW (17 March 2022).
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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ConsultationThe TGA sought comments on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019
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ConsultationDiscussion paper outlining different approaches to access and safety controls for alkyl nitrites
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ConsultationClosing date extended to 14 December 2018
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Corporate reportsARGMD landing page updated with links to new guidance.
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ConsultationThe IMDRF sought comments on a proposed document and its annexes
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ConsultationThe IMDRF sought comments on a proposed guidance document and two information documents
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ConsultationThe IMDRF is seeking comments on a proposed guidance document
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ConsultationThe TGA sought comments on the proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard to allow them to be advertised direct to consumers. Closing date 9 July 2018
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ConsultationConsultation on proposed process for pre-market evaluation of HCNs. Closing date: 12 January 2018
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ConsultationConsultation on future options for the regulation of personalised and 3D printed medical devices. Closing date: 22 December 2017
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ConsultationConsultation on proposed changes to up-classify surgical mesh medical devices and to provide patient implant cards for implantable medical devices. Closing date: 25 August 2017
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ConsultationConsultation on comparable overseas regulators. Closing date: 30 June 2017
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ConsultationOptions for the reform of the SPF and advertising controls of Schedule 3 medicines. Closing date: 28 April 2017
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ConsultationConsultation on discussion paper. Closing date: 11 January 2017.
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ConsultationConsultation on discussion paper. Closing date: 11 January 2017
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ConsultationIMDRF consultation document. Closing date: 2 December 2016
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ConsultationConsultation on draft guidelines. Closing date: 10 June 2016
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Media releasesInformation about the TGA operations over the 2015/16 Christmas/New Year period
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Media releasesStage two report for the Review of Medicines and Medical Devices has been released
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Media releasesThe Therapeutic Goods Administration has published an interim decision on a proposal to up-schedule codeine
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Media releasesThe TGA has imposed two new conditions on the inclusion of the SynchroMed II Programmable Pump in the Australian Register of Therapeutic Goods