Technical Alerts

An amendment order to amend the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) has now been registered on the Federal Register of Legislation. Please click here for more information.

Includes the updated Therapeutic Goods Permissible Ingredients Determination No.3 of 2017 and a reminder to register for the SME Assist Workshop. 

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Today’s Technical Alert provides the Therapeutic Goods Administration response to  and submissions received from the February 2017 public consultation ‘Reforms to the regulatory framework for complementary medicines: Assessment pathways’. 

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Today the draft list of permitted indications and a list of associated evidence qualifiers were made available on the TGA website.
Members now have the opportunity to review, comment and propose additional indications and evidence qualifiers, at no cost, until 31 October prior to the permitted indications reform coming into effect 1 January 2018. 

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Updates to the Medicines Advisory Statements Specification and the removal of requirements that apply solely to listed medicines. 

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The Pharmacovigilance and Special Access Branch (PSAB) of the TGA has recently drafted a revision of the Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines, also known as the Pharmacovigilance Guidelines.

CMA members are invited to participate in a targeted consultation for this revision Please provide your feedback via email to submissions@cmaustralia.org.au by close of business Friday 14 July 2017.

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Today’s Technical Alert includes information on Review and Appeal rights for ingredient applicants and calls for items of interest for TGA's Inaugural GMP Industry Forum.

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This Technical Alert includes information on the TGA’s targeted listing compliance review project in the area of macular degeneration and an update on the Pharmacovigilance Inspection Program.

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Today Australian Ministers, the New Zealand Minister responsible for food safety and the Australian Local Government Association met and agreed the priority areas for the food regulation system for both countries for 2017-2021.

Ministers discussed a range of food regulation issues, including finalising their investigation into low-tetrahydrocannabinol (THC), approving the draft standard that will allow low-THC hemp seeds to be sold as a food.

The Medicines and Medical Devices Regulation Review (MMDR) recommended (RX 37) that the TGA develop and maintain, in real time, a catalogue of approved ingredients for use in listed medicinal products that is readily accessible to sponsors and the general public.

CMA is pleased to announce that the online catalogue of ingredients approved for use in listed medicines has been finalised and is now available.