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…
Last updated: 26 March 2025 To see updates, click the’+’ sign below: 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 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…
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, 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…
Last updated on: 24 November 2021. See update at the end of the post. TGA, Australia is consulting on the remaking of some TGOs and other legislative instruments for human cell and tissue (HCT) products. What are Therapeutic Good Orders…
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…
TGA, Australia has published guidance on the imminent reclassification of certain medical devices. Which medical devices are going to be reclassified? The following medical devices are going to be reclassified: Medical devices in direct contact with the heart, central circulatory…