medicines-medical devices-regulatory affairs
This post concerns the introduction of temporary new arrangements by the TGA, for GMP inspections of: When were the temporary new arrangements for GMP inspections introduced and what are they called? The temporary new arrangements for GMP inspections were introduced…
The TGA has published a list of changes to medical device regulations. The table below is an attempt to present the information in a manner such that it can be read easily. Devices or audit application requirements Changes already in…
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…
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…
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…
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…
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…
The TGA is conducting a follow-up consultation on the repurposing of medcines. What is repurposing? TGA defines repurposing of medicines as the process of identifying potential new therapeutic uses (or ‘indications’) for older medicines through new research and evidence. This…
The TGA, Australia is consulting on a proposed priority pathway for assessment of certain novel and life-saving biologicals. Who is the consultation for? The consultation is for consumers, healthcare professionals and the industry. What is the purpose of the consultation? The…
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…