Australians Rewrite Complementary Medicine Rulebook

Times are changing in the world of Australian complementary medicine regulations and New Zealand producers will need to act fast or risk losing out to their competitors for sales across the ditch. That is the advice Australian regulatory consultant Robert Forbes gave the audience at the Natural Health Products New Zealand Suppliers Day in Auckland. Recent TGA changes include removal of the free text option when making product claims/indications (applicants will need to select their product claims/indications  from a drop-down list of over 1000 approved indications) and changes to regulations related to new ingredient assessments. There is a new approval pathway for non-prescription medicines to be sold in Australia (called Aust L Assessed; AUST L A whichsits in between Listed and Registerd medicine categories and allows manufacturers to make slightly more powerful claims about their products’ health effects if they have the supporting evidence.   Source: Jonathan Chilton Towle, (Subscription) Australian V NZ regulations

TGA Rules on the Implementation of a ‘Claimer for Efficacy Assessed Non-Prescription Medicines’

The TGA has ruled on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. Eligible products will be ableto carry higher level health claims than current Listed (AUST L) products, including health benefits for more serious health conditions. Government-recognised status of the efficacy of Complementary Medicines (CMs) which hold higher level health claims puts Australia at the cutting edge of global regulation of CMs. The claimer, to be applied voluntarily by the sponsor of the approved product, will appear in the form of a diagram on the product label. The optional statement on the label will be: ‘Evidence for the approved indications has been assessed by the TGA’). The claimer will be introduced for assessed listed medicines (which may include complementary and OTC medicines) and registered complementary medicines only.    Source:  Efficacy claimer ruling  

TGA Publishes Current List of  Evaluated Registered Complementary Medicines

Registered complementary medicines are considered to be of relatively higher risk than listed medicines, based on their ingredients or the indications made for the medicine. Registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to being accepted on the Australian Register of Therapeutic Goods (ARTG) and able to be marketed. Medicines registered on the ARTG are assigned a unique AUST R number, which must be displayed on the medicine label. The following link sets out the registered complementary medicines on the ARTG that have been evaluated by the TGA for safety, quality and efficacy: Registered comp meds

TGA Considers Comparable Overseas Regulators for Medical Device Applications

The TGA is expanding the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting their applications for inclusion of medical devices in the ARTG. As soon as legislation is finalised, the number of comparable overseas regulators and assessment bodies will be expanded to include peak European, Canadian and Japanese regulatory agencies.   Source: Medical device regulation

TGA Updates Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2018. A total of 10 changes have been made in the updated Determination. These changes include: the addition of 5 new ingredients; changes to 5 existing ingredient entries; and, correcting the approved ingredient name.   Source: Permissible ingredients update

TGA Recalls NET Remedies Homeopathic Products

Consumers and health professionals are advised that NET Remedies, in consultation with the TGA, is recalling all unexpired aqueous-based products currently in the supply chain due to possible microbial contamination. It has been identified that a fault in the water filtration system from the North Carolina manufacturer resulted in four batches being contaminated by Pseudomonas spp.   Source: Homeopathic recall

TGA Safety Advisories—   Source:

For the first time, in many years, this month there have been no reported illegal medicines containing Viagra / Cialis like substances imported into Australia!

Weight-Loss 'Shredder' Drugs Containing Toxic DNP Linked to Deaths

Health authorities are warning the public against weight-loss products containing a toxic chemical that have caused multiple deaths in Australia and overseas. The drugs containing the chemical 2,4 dinitrophenol (DNP) are marketed as "shredders" to the fitness, weight-loss and body-building communities. The toxic substance used to make herbicides and explosives causes serious illness and death. Several young people have died after taking the drugs in Australia and internationally according to NSW Health. DNP prevents energy from being stored as fat; instead it releases energy as heat, which increases body temperature. That can damage the cells of organs including the kidney and brain.    Source: Kate Aubusson, SMH Weight-loss shredder

TGA Provides Update on the Compliance Verification (CV) GMP Clearance Applications Backlog

In 2017-18 a total of 5,327 GMP Clearance applications were received. This compares with over 5,400 applications in 2016-17 and over 5,600 in 2015-16. This has created a backlog of applications and has extended the processing times for CV clearance applications. To address the backlog, in September 2017 the TGA implemented a range of GMP Clearance process improvements and a streamlined compliance verification process. Analysis of the CV GMP Clearance applications shows that there has been a substantial reduction in the number of CV applications across the board.    Source: GMP backlog

TGA Facebook Has Officially Launched

Facebook is a popular forum for consumers to discover and share information, with 60% of Australians being users of social networks including Facebook. The TGA Facebook page extends its reach with these consumers, increasing awareness of its role as Australia’s regulator of medicines, medical devices, blood, cell and tissue products. Consumers can use the page to find information and tips on the safety of medicines and medical devices, while health professionals can use it to follow the latest news and guidance on the regulation of therapeutic goods.    Source: TGA Facebook

TGA Publication of Interim Decisions Proposing Amendments to the Current Poisons Standard

Affected substances include: Sildenafil; Budesonide; Alkyl nitrites; Codeine; Cannabidiol and tetrahydrocannabinols (THCs); Paracetamol combined with ibuprofen; 2-Butoxyethanol; Dimethyl sulfoxide (DMSO); Aliphatic allyl esters; &, Astodrimer sodium. Further comments are due to the TGA by 11 October 2018.    Source: SUSMP scheduling

The Rhetoric Around What Constitutes 'Good' Evidence Has Become Increasingly Polarising

The debate about what constitutes 'good evidence', always a controversial point, has recently become even more heated, writes complementary medicines consultant Michael Smith.   Source: Gary Scattergood, Nutraingredients-Asia  'Good' evidence

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