Listed Medicine Compliance Rating Scheme Has Begun

The TGA’s Listed Medicine Compliance Rating Scheme commenced on 28 November 2018 as part of its existing compliance review process. As listed medicines are not evaluated by the TGA before they are included on the Australian Register of Therapeutic Goods (ARTG), they conduct post-market compliance reviews on a proportion of those on the ARTG each year to ensure their ongoing safety, quality and efficacy. To support the publication of review outcomes on the TGA website, they have developed a Listed Medicine Compliance Rating Scheme (the Scheme). The Scheme is intended to aid consumers in interpreting the outcomes of compliance reviews after they get published on the TGA website. This will enable consumers to make informed choices about their use of self-selected medicines and provide an incentive for sponsors to improve overall compliance of their products.   Source: Compliance rating scheme

TGA Fines Company Over $25,000 for Alleged Importation of Unapproved Therapeutic Goods

Australian company ESCHOICE Pty Ltd will pay penalties of over $25,000 after the Therapeutic Goods Administration (TGA) issued infringement notices for the alleged importation of unapproved therapeutic goods, namely medicines and medical devices for use in cosmetic procedures. Australian Border Force officers seized the imported therapeutic goods as part of Operation Antlia, a compliance initiative of the TGA. The TGA initiated Operation Antlia to target the illegal use of therapeutic goods in the cosmetics industry after a woman died from a cosmetic procedure at a Sydney clinic last year.   Source: Operation Antlia

TGA Updates 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 in December 2018. A total of 6 changes have been made in the updated Determination. These changes include changes to 5 existing ingredient entries, including making requirements clearer and less restrictive; and, removal of 1 ingredient that was a proprietary formulation and incorrectly classified as being appropriate for use in listed medicines during the drafting of the original Determination. The removed ingredient is not currently used in any listed medicines in Australia.    Source: Permissible ingredients

TGA Consultation: Remaking Therapeutic Goods Order No. 78

The TGA is seeking comments from interested parties on the proposed remaking of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules and reintroducing pills into the remade Order. This consultation closes on 8 February 2019.    Source: TGA 78 consultation

TGA Reviews the Narcotic Drugs Act 1967

The Narcotic Drugs Act establishes a framework to both prevent abuse and diversion of controlled narcotics and to ensure the availability of such drugs for medical and research purposes, in accordance with the Single Convention on Narcotic Drugs. Since October 2016, the Act was extended to provide for the regulation of cannabis cultivation and production in Australia, to enable a sustainable supply of safe medicinal cannabis products for therapeutic purpose.    Source: Narcotics review

TGA Takes Action Against Peptide Clinics Pty Ltd for Alleged Advertising Breaches

The Secretary of the Department of Health has begun Federal Court proceedings against Peptide Clinics Pty Ltd, trading as Peptide Clinics Australia, alleging breaches of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2015 (the Advertising Code). This legal action follows an investigation by the Therapeutic Goods Administration. Peptide Clinics Australia is alleged to have advertised compounded prescription only therapeutic goods, including 'peptides', on its website and other social media platforms, accessible to both registered customers and the public. It included references to serious forms of diseases, and to conditions such as anxiety and depression.    Source: Peptide Clinics busted

TGA Safety Advisories—   Source:

THAN YOU tablets: the tablets contain the undeclared substance sibutramine.

NZ Therapeutic Products Regulatory Scheme Consultation

New Zealand’s Ministry of Health is seeking feedback on the draft Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. Please note that Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process.   Source:  NZ Therapeutic products bill

AHPA Issues Status Report on Hemp and CBD After USA Farm Bill Passage

The American Herbal Products Association has produced a Status Report after working with legal and industry experts to develop a new, free resource titled Status Report: Marketing of hemp and cannabidiol (CBD) products in the United States, following passage of the 2018 Farm Bill. This document provides concise and up-to-date information on the status of such operations and products as soon as this legislation is adopted as federal law. Because of the herbal product industry’s broad interest in the impact of this legislation on hemp and CBD, AHPA is distributing this information before the bill has been signed into law. The 2018 Farm Bill has been passed by the Senate and House, but still needs to be signed into law by the President. AHPA is not aware of any indications that successful and timely completion of this is in doubt.   Source: 2018 Farm Bill passage


RFA Breaking News

Complementary Medicines (“Dietary supplements”):

  TGA Fees and Charges Summary from 1 July 2019 The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods…



  Raw Potential? New Zealand Opens Raw Milk Regulations Review for Consultation The New Zealand Ministry of Primary Industries (MPI) has launched an online survey seeking public consultation on the…


Cosmetics and TGA Listed Sunscreens

  Early Regulatory Changes Affecting Chemical Importers and Manufacturers Now in Affect Whilst the new scheme will begin on 1 July 2020, early regulatory changes are now in effect under…



  Imports Still Impress: Survey Reveals Chinese Consumers Place Premium on Overseas Supplements More than half (53.7%) of the Chinese consumers surveyed said they bought imported nutrition supplements, while only…


Complementary Medicines (“Dietary supplements”):

  TGA Issues Guidance for TGO 101 (Standard for tablets, capsules and pills) This guidance includes clarification on, and information relating to, mandatory requirements. It also includes additional information to…



  Special Report: Strawberry Tampering and its Aftermath This article from Food Legal addresses the February 2019 report by government body Food Standards Australia New Zealand (FSANZ). FSANZ had been…


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