Reforms to the Regulatory Framework for Complementary Medicines

In February 2017 the TGA announced a public consultation, ‘Consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways’. A total of 60 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format.    Source: TGA reforms

Broad Support for New ‘Third Way’ Supplements (Complementary Medicine) Health Claims in Australia: TGA

Australian regulator the Therapeutic Goods Administration (TGA) says there is broad support for plans to introduce a ‘third level’ of health claims for supplements (complementary medicines).    Source: Gary Scattergood+, NutraIngredients TGA 3rd way

Updates to the 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 July 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017. A total of 67 changes have been made in the updated Determination. These changes include the addition of 4 new ingredients; Changes to 55 existing ingredient entries; and, the removal of 8 ingredients that have been determined not to be suitable for inclusion in listed medicines. A complete list of changes to ingredient availability is available here: Permissible ingredients

TGA Announces Electronic Signatures to Replace 'Wet Ink' Signatures

All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and no longer contain a wet ink signature. This initiative will position industry for a future move to online self-service.    Source: e-Signatures

TGA Safety Advisories –

V8 tablets; & Sirrori Green Viagra Tablets: the tablets contain the undeclared substance sildenafil    Source: V8 tabs ; Sirrori tabs

Jing Pin Heijin Gang Tablets: the tablets contain the undeclared substances sildenafil and paracetamol    Source: Jing tabs

RUFF Natural Formula capsules: the tablets contain the undeclared substances tadalafil, sildenafil and dapoxetine    Source: Ruff tabs

RFA Breaking News

Complementary Medicines (“Dietary supplements”):

  TGA Releases Updated Australian Regulatory Guidelines For Complementary Medicines (ARGCM) The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public…

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Foods:

  Failing Food Report This report details food that was found to fail under the Imported Food Inspection Scheme. The noncompliant food was not distributed for sale in Australia. It…

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Cosmetics (& Household cleaning products):

NICNAS Calls for Consultation on General Rules, Categorisation Guidelines and Transitional Rules The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) helps protect the Australian people and the environment by…

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Marketing News:

'Unofficial' Exports Of Aussie Supplements To China Estimated At $800m Daigou shoppers are believed to have accounted for $800m of 'unofficial' supplement exports from Australia to China in the past…

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Marketing News:

  Nature's Care Sale: Chinese Private Equity Firms Take Majority Stake In Aussie Supplement Brand Two Chinese private equity firms, JIC Investments and Tamar Alliance Fund, have bought a majority…

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Cosmetics (& Household cleaning products):

  False Flush: Company Behind White King 'Flushable Wipes' Fined $700k Pental Limited and Pental Products Pty Ltd is the manufacturer behind White King's "flushable" toilet and bathroom cleaning wipes.…

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