TGA conducting forum on GMP

This will be a virtual event, to be held from Wednesday 12th to Friday 14th May, free of charge for members of the industry. More information is available here, and to register to attend click here.

 

Half yearly performance snapshot: July to December 2020

The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the financial year and is available on the TGA website. This Half Yearly Performance Snapshot provides statistical information for the period 1 July 2020 to 31 December 2020 in relation to the regulation of therapeutic goods, tracking of progress against some of the priorities identified for the year. This data will be incorporated into the Annual Performance Statistics Report for the 2020-21 financial year, to be published on the TGA website in the second half of 2021.    Source: TGA news

  

Update on the poisons scheduling of psilocybin and MDMA

An independent review has been commissioned into the therapeutic value, risks and benefits to public health outcomes for these substances. Amended timing on the scheduling process for these substances will be published on the TGA website following the completion of the independent review.    Source: TGA

  

Changes to regulation of nicotine e-cigarettes

These changes affect nicotine e-cigarettes, nicotine vaping products (also known as eJuice, vape juice, eLiquid), and novel nicotine delivery systems, such as heat-not-burn tobacco products. They do NOT affect nicotine replacement therapies, such as sprays, patches, lozenges, chews and gums, or e-cigarette products that do not contain vaporiser nicotine. From 1st October you will no longer be able to legally buy these products from overseas websites without first talking with a GP and getting a prescription. These products cannot be sold anywhere in Australia without a doctor's prescription, and the possession and use of these products without a prescription is illegal in all states and territories except South Australia. Between 2015 and 2019, e-cigarette use by young people increased by 96 per cent in Australia. There is evidence that nicotine e-cigarettes act as a 'gateway' to smoking in youth and exposure to nicotine in adolescents may have long-term consequences for brain development.    Source: TGA

  

Advertising health services

An advertisement for a health service is not considered an advertisement for therapeutic goods, unless you refer to therapeutic goods used in the delivery of the service in the advertisement. Products mentioned in this summary guide include cosmetic injectables, medicinal cannabis, compounding pharmacies, vaccine providers, biologics, and more.    Source: TGA

  

Decisions to amend, or not to amend, the poisons scheduling of certain substances as at 22nd April

This mentions substances that have had their poisons scheduling amended, and those that have not been changed, and discusses the reasons for the decisions. Includes amygdalin and hydrocyanic acid, bilastine, budesonide and formoterol, azoxystrobin, triticonazole, azelaic acid, 2-hydroxyethyl methacrylate (2- HEMA), magnesium hydroxide, tetrahydrofurfuryl alcohol, cannabidiol.    Source: TGA

  

Supply and wholesaling of medicinal cannabis products (MCP)

Both sponsors of products, and other persons who are not the sponsor, are prohibited from supplying unregistered MCP by wholesale. This guide summarises the compliance obligations associated with the storage and supply of the products.    Source: TGA

  

Regulation of medical device software

This is a TGA presentation delivered at an industry masterclass. When is software a medical device? A summary of reforms and international alignment.    Source: TGA

 

TGA case studies

The TGA is publishing case studies to provide examples of how regulations are enforced.

Food-medicine interface: the example given is a complaint about advertising which presented products as formulated supplementary sports foods, but included claims of a therapeutic nature, including conditions such as depression and autoimmune conditions. The company did not take sufficient action after being contacted by the TGA, so was issued infringement notices totalling $301,400 for 21 counts of advertising therapeutic goods not on the ARTG, two counts of using a prohibited representation and one count of using a restricted representation without TGA authorisation. The company paid the infringement notices.

Homeopathic melatonin: the product was not prepared according to homoeopathic principles and the amount of melatonin present was not sufficient to justify the claims. It was decided that describing these medicines as homeopathic melatonin could be misleading.

Weight loss products: the example given here is one of the “FatBlaster” products. The sponsor of the product could not provide satisfactory evidence to support the claims being made. The product was cancelled on 20 December 2019.

Restricted representations: multiple complaints were received about BioCharger, a medical device that emitted light, but was not included on the Australian Register. Claims on Facebook implied the BioCharger was capable of having an effect on COVID-19, as it was 'programmed with about a thousand different recipes, there's a couple on there for Wuhan coronavirus'. The company website contained other therapeutic claims. The company paid two infringements notices totalling $25,200. The device was being sold for $15,000.

RFA Breaking News

Cosmetics, Personal Care and TGA Listed Sunscreens:

New sunscreen standard in force New sunscreen standard in forceThe new sunscreen standard, AS/NZS 2604:2021, specifies requirements and test methods for broad spectrum and water resistant sunscreen products. Includes labelling…

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Foods:

New biosecurity website A new website - biosecurity.gov.au - details measures in place to protect Australia from harmful pests, diseases and weeds. This gathers information previously found on different state…

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Complementary Medicines and Medical Devices:

Hemp seed oil - change of status An interim decision has been made to exclude hemp seed oil from Schedule 9 of the poisons schedule whe used for oral consumption…

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Cosmetics, Personal Care and TGA Listed Sunscreens:

Animal testing ban explained Laws that banned testing cosmetics on animals in Australia came into effect in July 2020, this is a helpful article for consumers which highlights the role…

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Foods:

Changes on testing of imported foods Particularly relevant to powdered infant food formula (Cronobacter testing commenced and Salmonella testing continuing), infant follow formulas (Salmonella testing commencing) and milkfish (Chanos chanos) -antimicrobial…

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Complementary Medicines and Medical Devices

New TGA fees now in place TGA fees rise at the beginning of the financial year i.e. the 1st July. For nonprescription medicines go here. The application fee for a…

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