Articles

The Prescribing Medicines in Pregnancy database has now been updated.

The Generic Medicines Work-Sharing Initiative has updated its Operational Procedures document and Expression Of Interest form.

Before you take a weight loss supplement or medicine, there are things to consider.

A warning to social media influencers and advertisers not to advertise this prescription medicine.

Find out about the requirements starting on 1 January 2023 for medicines that are serialised or include a data matrix code.

The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.

Tell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.

TGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.

The TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.

The TGA has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'.

The TGA is providing guidance on surrogate viruses that may be used to test disinfectants making claims of efficacy against Monkeypox.

COVID-19 vaccines that have received a provisional determination from the TGA.

The Prescribing Medicines in Pregnancy database has now been updated.

On 10 July 2020 the Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19

On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

The TGA has now approved an application from the sponsor for an extension of shelf-life to 18 months when stored at 2°C to 8°C.

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its tixagevimab and cilgavimab (EVUSHELD) for the treatment and prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19.

The TGA has granted a second provisional determination to Gilead Sciences Pty Ltd in relation to its COVID-19 treatment, VEKLURY (remdesivir).

On 18 January 2022 the TGA granted provisional approval to Merck Sharp & Dohme (Australia) Pty Ltd for its oral COVID-19 treatment, LAGEVRIO (molnupiravir).

On 18 January 2022 the TGA granted provisional approval to Pfizer Australia Pty Ltd’s oral COVID-19 treatment nirmatrelvir + ritonavir (PAXLOVID).

The new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022