Articles

This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations

Access Consortium guidance for strain changes to COVID-19 vaccines

Invitation to the National Measurement Institute's mask/respirator testing forum.

Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021.

Updated to include new section on Reprocessing of PPE by Healthcare facilities

Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.

The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.

The TGA is warning consumers that off-label use of so-called smart drugs, such as Modafinil, is not a wise choice.

The Regulation Impact Statement (RIS) and the regulatory burden costing have been published alongside the delegate's final decision on the scheduling of nicotine.

The Access Consortium regulatory authorities have pledged their collective support in countering the COVID-19 global pandemic

The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.

The electronic application form for a Conformity Assessment Certificate has been updated

On 16 November 2020 the TGA granted a provisional determination to Janssen in relation to its COVID-19 vaccine, Ad26.COV2.S.

On 6 October, as part of the 2020-2021 Budget, the Australian Government announced it will establish a Unique Device Identification (UDI) database for medical devices

Changes to the process for responding to post market reviews.

The heads of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium are pleased to announce that the MHRA is joining as a new member

The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA]

The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant]

In Australia, a sports supplement can be classified as either a food or a medicine

TGA has launched the new Early Scientific Advice service, allowing applicants to request advice on biowaiver justifications

Medicine labels started to change in 2020 to be more consistent, highlight key information and align with medicine labels used in other countries.

Information on generic prescription medicines

The independent review is complete and the report now published

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia.

Pharmacies can return children's paracetamol liquid formulations to front-of-counter, but the one unit limit on sales remains in place