Guidance on submitting prescription medicines applications has been updated to reflect recent reforms.
Submissions received on the Therapeutic Goods Advertising Code have been published
Role of the ACMD The Advisory Committee on Medical Devices (ACMD) provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, performance and manufacturing of medical devices supplied in Australia including issues relating to pre-market conformity assessment and post-market monitoring. […]
Therakos cellex photopheresis system safety advisory – risk of blood clots under investigation
Added a link to the eCTD validation tool
The TGA provide clarification to the recent article from Pharma in Focus.
The Therapeutic Goods Administration (TGA) engaged Deloitte to undertake a review of its current Good Manufacturing Practice (GMP) fees and charges for medicines and Active Pharmaceutical
The proposed reforms are designed to give greater certainty and protection for consumers
A recent media report suggesting that half of TGA approvals for prescription medicines in 2017 exceeded statutory timeframes is incorrect
Proposed changes intended to be incorporated into the Permissible Ingredients Determination for March 2018 and June 2018.
The TGA is seeking comments from interested parties on a proposal to remake TGO No. 77 – Microbiological Standards for Medicines (TGO 77).
Current regulation of autologous human platelet-rich plasma and conditioned serum
Alectinib (ALECENSA) is the first medicine to be registered on the Australian Register of Therapeutic Goods (ARTG)(link is external) via TGA’s new Priority review pathway, which came into effect on 1 July 2017. The application extends the previously registered indications to include the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally […]
Perfect Slim capsules by Peenuch pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Perfect Slim capsules by Peenuch and found that: The capsule contains the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only […]
Throughout the year we publish information on new generic and biosimilar prescription medicines when they are approved. Please note that the sponsor name reflects the information in the Australian Register of Therapeutic Goods (ARTG) at the time of registration. As sponsors may change over time, please consult the ARTG for […]
The Poisons Standard(link is external) is a Legislative Instrument for the purposes of the Legislative Instruments Act 2003. The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. The Poisons Standard also includes model […]
This list comprises of previously available over-the-counter (S2, S3) codeine-containing products that have been up-scheduled to prescription medicine (S4) via application to the TGA. You should contact the sponsor to confirm their intention to continue marketing their goods in Australia, after 1 February 2018. Products containing other codeine derivatives, such […]
The TGA’s Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete. The survey will remain open until 31st March 2018. Background The TGA’s PVIP Risk Assessment Survey is designed to inform the TGA about a sponsor’s medicine portfolio, pharmacovigilance processes and compliance with Australian […]
34 New chemical or biological entity registrations 46 New or extended uses, or new combination registrations 21 Orphan Drug registrations 101 New generic medicine registrations 69 AusPAR publications New chemical or biological entity registrations by year New generic medicine registrations by year On this page: Introduction | Some innovative and […]
The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids