Category TGA (Australia)

TGA updates on GMP clearance for an overseas manufacturing site

This post the following TGA updates on GMP clearance for an overseas manufacturing site: 1. GMP clearance sponsor information dashboard and guidance updates This update concerns sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site…

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Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies

Last updated: 18 March 2023 See updates at the end of this post. This post is an attempt to provide some basic information on Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies. An important limitation…

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TGA Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey for medicine sponsors

The TGA is conducting a Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey for medicine sponsors. The survey is now open for medicine sponsors to complete.  Background to the survey The survey is designed to inform the TGA about the following…

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TGA responds to the Report on ‘Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives’

The TGA has responded to the issues raised in the 2021 Report on Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives Background First introduced in May 2011, the regulatory framework for biologicals provides the legislative basis for the…

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TGA publishes new guidance on the GCP inspection of clinical trial sites for investigational products

The TGA has published new guidance entitled Good Clinical Practice (GCP) inspection program – Guidance for GCP inspection of clinical trial sites for investigational biologicals and medicinal products Clinical trials of medicines and biologicals regulated under the Clinical Trial Notification…

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TGA updates guidance on aspects of Australian manufacturing licences and overseas GMP certification

The TGA, Australia has updated several updated guidance documents on aspects of Australian manufacturing licences and overseas GMP certification. 1) Applying for a manufacturing licence for an Australian manufacturing site This updated step-by-step, 47 page guide (version 2.2, Dec 2021) with…

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TGA update on GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic

The TGA, Australia has provided an update on its GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. The update concerns certain temporary measures introduced in 2020 for overseas manufacturers. The following items are addressed: On-going…

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