Australian regulatory action on breast implants and breast tissue expanders

Australia – Standard for serialisation and data matrix codes on medicines

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in...

Australia – Melbourne-made COVID-19 vaccine now available

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the Therapeutic Goods Administration (TGA) this evening approving the release of the first four...

Australia – Medicine labels: Guidance on TGO 91 and TGO 92

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders. There are different risks...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Third Japanese company begins COVID-19 vaccine trials

Japan’s KM Biologics Co said on Monday it had started a human trial for its COVID-19 vaccine, becoming the country’s third candidate to advance...
Australian regulatory action on breast implants and breast tissue expanders

Australia – New legislation to support medicine substitutions

New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's usual medicine has been declared to be in...

Australia – TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines...

TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the United Kingdom. The guidance lays...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – TGA collecting COVID-19 vaccine side effect reports

Australia's safety monitoring system for COVID-19 vaccines is operating and weekly reports will be published from this Wednesday. The Therapeutic Goods Administration (TGA) is collecting...

Australia – The TGA’s risk management approach

Version 5.0, February 2021 This guidance outlines the broad approach adopted by the Therapeutic Goods Administration (TGA) to identify and manage risk associated with therapeutic goods...
Australian regulatory action on breast implants and breast tissue expanders

Australia – Advertising COVID-19 vaccines to the Australian public

The advertising of prescription medicines (including vaccines) to consumers is generally prohibited in Australia. However, the use of specific promotional materials to advertise COVID-19...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – TGA one of only five non-European regulators invited to participate on European...

Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA) on the...

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