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- GMP Clearance: Extension processing timesNoticesDelays in processing timeframes of applications to extend GMP Clearances.
- Updates to the Prescribing Medicines in Pregnancy database, May 2023NewsThe Prescribing Medicines in Pregnancy database has now been updated.
- TGA targets unlawful importation of prescription medicinesMedia releasesThe TGA has issued 5 infringement notices to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines.
- Important safety information for Janus kinase (JAK) inhibitorsSafety updatesNew warnings for baricitinib, tofacitinib and upadacitinib follow a TGA review of a randomised safety trial called the ORAL Surveillance Study.
- TGA publishes updated guidelines for sunscreensNewsThe TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination
- EU MDR transition extensionNewsThe TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
- COVID-19 vaccine safety report - 04-05-23COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Live vaccines – what are the contraindications?Safety updatesMedicines Safety Update - Information for health professionals
- Removal of prescribing restrictions on ivermectinMedia releasesFrom 1 June 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists.
- TGA makes final decision to reduce paracetamol pack sizesMedia releasesThe TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.
- Update to listed medicine ingredients in May 2023NoticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.
- Surveys - Medical devices manufactured at the Point-of-CareNewsWe are conducting surveys to collect information about medical devices manufactured at the point-of-care.
- Moderna’s COVID-19 vaccine SPIKEVAX receives approval for full registrationMedia releasesThe TGA has approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.
- COVID-19 vaccine safety report - 20-04-23COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Infringement notices totalling $66,600 given to three Sydney-based companies and two individuals for alleged unlawful importation of nicotine vaping productsMedia releasesThe TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products.
- First Mpox (monkeypox) test kit approved for AustraliaNewsThe TGA has approved the first commercially supplied test kit for the detection of Mpox (monkeypox) virus.
- COVID-19 vaccine safety report – 06-04-23COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Dual labelled medicines begin transition to sole medicine ingredient names soonNewsFind out about new transition arrangements for dual labelled ingredient names.
- Therapeutic Goods (System for Australian Recall Actions) (Arrangement for Computer Programs) Instrument 2023NoticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
- Understanding the changes to MDMA and psilocybin accessBlogFrom 1 July 2023, authorised psychiatrists can prescribe psychedelic medicines to people with specific mental health conditions under strict controls.
- Changes to medical device essential principles for nanomaterialsNewsEssential principle 7 now mentions nanomaterials explicitly (see EP 7.7)
- Company director sentenced to 2 years imprisonment with personal and company fines of over $2.5 million for selling illegal SARMsMedia releasesChristopher Ramsey, the Director of AusLabs, Smart Labs and iSARMs, has been sentenced 2 years imprisonment and fined $300,000 for his role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. Mr Ramsey’s three companies also received significant fines totalling $2,225,000.
- Product Information safety updates - March 2023Safety updatesMedicines Safety Update - Information for health professionals
- TGA’s new powers will help reduce the impact of medicine shortages on patientsNewsFrom 22 March 2023 changes to the Therapeutic Goods Act 1989 will help alleviate the effects of medicine shortages on patients.
- COVID-19 vaccine safety report - 23-03-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.