Articles

The TGA completed a desktop review of selected listed sunscreen products.

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Our annual survey measures satisfaction with a range of services and activities including our role and performance

Apalutamide (Erlyand) is the first medicine approved via ACSS Consortium’s NCE working group

Consumers can now report dodgy ads for medicines and medical devices through a single online form

Oral methotrexate dosing, medicines associated with a risk of neuropsychiatric adverse events, and clozapine and gastrointestinal effects

Caitlin's story explains how a patient in Australia can legally access medicinal cannabis.

List of OTC codeine-containing products moving to prescription only

This instrument applies to an application to list a complementary medicine under section 26AE of the Act.

This instrument applies to an application to list a medicine under section 26 or 26A of the Act.

This instrument applies to an application to register a complementary medicine

How TGA uses joint replacement registry data; Focus on skills for vacuum-assisted births; TGA reviews product safety of ventilators

Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form.

This instrument applies to the online form titled Prescription Medicines Designation/Determination Application in the TGA's electronic lodgement facility, completed in accordance with the relevant instructions in that form.

Information about influenza vaccines for use in 2018

In reference to the ABC’s Fact Check article “Will the move to make codeine prescription-only save a100 lives a year” the Therapeutic Goods Administration (TGA) would like to clarify:

Information to help sponsors understand the provisional approval pathway for prescription medicines.

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Preventable alarm issues; Review into cochlear implants; NHS cylinder alert; recent safety alerts

s23 instruments supporting the new COR process have been updated.

s23 instruments supporting the new COR process have been updated.

The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids

The TGA has issued a discussion paper on the use and misuse of prescription strong opioids, such as oxycodone, and whether there is a need for specific regulatory responses

Inappropriate use of scalpel removers; ransomware named as 2018's 'top hazard'; joint registry data; recent safety alerts

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under paragraph 61(2)(a)(iii) of the Act to release information from the Adverse Event Management System to the World Health Organization.