TGA Launches Pilot of Medical Device Single Audit Program
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TGA Launches Pilot of Medical Device Single Audit Program

The Therapeutic Goods Administration (TGA) launched the Medical Device Single Audit Program (MDSAP) pilot program, starting from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration (USFDA). The TGA and MDSAP participation The MDSAP is designed to ensure a single audit of a medical…

Consultations on adoption of EU guidelines in Australia
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Consultations on adoption of EU guidelines in Australia

EU guidelines A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below: Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture. Guideline on the requirements for quality documentation…

What impact does the recently published ‘blood and tissues’ code of GMP have on the life sciences industries?
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What impact does the recently published ‘blood and tissues’ code of GMP have on the life sciences industries?

In April 2013, the Australian Therapeutic Goods Administration released the first version of its much anticipated Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. These requirements commenced on 31st May 2013 with a 12-month grace period requiring full compliance by 31st May 2014. Within…

History of TGA Proposal for Automatic Adoption of New Versions of the PIC/S Guide to GMP
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History of TGA Proposal for Automatic Adoption of New Versions of the PIC/S Guide to GMP

TGA adoption of PIC/S GMP Guide for Medicinal Products Which version of the PIC/S GMP Guide does the TGA refer to? PIC/S Version 14, PIC/S Version 15, or PIC/S Version 16? PIC/S GMP Guide PE 009-15 (PIC/S Version 15) was published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in May 2021. This version (Version 15)…

TGA releases: Reform of Medical Device Regulation (TGA historical documents)
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TGA releases: Reform of Medical Device Regulation (TGA historical documents)

TGA REFORMS – HISTORICAL DOCUMENT (blog originally published 21 May 2013): The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January. The RIS provides details on…