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

This issue of RFA Newsletter is sponsored by:

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Complementary Medicines (“Dietary supplements”):

BREAKING NEWS! Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 Update The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th…



Forum Reviews Fast Food Menu Labelling Schemes The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) is conducting a review of fast food menu labelling schemes in…


Cosmetics (& Household cleaning products):

NICNAS Public Consultation Forecast The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the use of all chemicals within Australia, as well as helps protect the Australian people and…


Pharmacovigilance Obligations Training - COURSE AVAILABLE

In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST…


RFA wishes all of our readers a Happy & Prosperous New Year

Sydney New Year fireworks


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