TGA Consultation: Business Process Improvements Supporting Complementary Medicines Assessment Pathways

The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation. The purpose of this consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of business processes aimed at improving the regulation of complementary medicines in Australia. Interested parties should respond by close of business Tuesday, 7 November 2017.    Source: Consultation pathway

TGA presentation at the 2017 ARCS Annual Conference, August 2017

ARCS Australia is a professional development association representing individuals involved in the development of therapeutic products. Transcripts and slide-shows from all of the TGA presentations delivered at this annual conference can be viewed here: 2017 ARCS conference

Medicinal Cannabis 'Red-Tape' Pushing Doctors and Patients Back to Illegal Products

In last month’s edition of this newsletter, we covered a story titled “TGA Addresses Issues Related to Supply of Medicinal Cannabis in Australia” which generated a considerable amount of interest in our readers, not least because it seems that in spite of legislative changes that aimed to increase the availability of medicinal cannabis to Australian health consumers, the health bureaucracy has sought to frustrate the government’s initiatives by insisting that supply be dependent on evidence of effectiveness. But, as with the chicken-&-egg paradox, if supply remains severely curtailed, how can the evidence be accumulated? Sydney GP Brad McKay, Brisbane father Steve Peek, and Teresa Nicoletti, a partner at the law firm Mills Oakley, all explain the impact that this impasse is having on theirs and others’ lives.   Source: ABC News Green tape

Australia Government Backs Evidence Based Research for All Health Care

The National Health and Medical Research Council (NHMRC) has a responsibility to inquire into, issue guidelines on, and advise the community on, matters relating to: the improvement of health; the prevention, diagnosis and treatment of disease; the provision of health care; public health research and medical research; and ethical issues relating to health. All health treatments, whether conventional, traditional or complementary, should be subject to a rigorous evaluation of the evidence for effectiveness.  In the NHMRC Strategic Plan 2010–2012, ‘examining alternative therapy claims’ was identified as a major health issue for consideration by the organisation, including the provision of research funding. In the current Strategic Plan 2013–2015, NHMRC has broadened its focus to investigate the general issue of ‘Claiming benefits for human health not based on evidence'.    Source:Complementary research

Nutrient Reference Values for Sodium Updated

The sodium nutrient reference values (NRVs) for the Suggested Dietary Target and Upper Level of Intake for adults were approved by the National Health and Medical Research Council (NHMRC) on 13 July 2017 and have now been published. Excess sodium intake continues to be strongly associated with increased risk of hypertension and some cardiovascular and kidney events.    Source: Sodium intake 

Exposure drafts: Therapeutic Goods Amendment Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017

The TGA sought comments from interested parties on the exposure draft Bills amending the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989. This consultation closed at 9am on 5 September 2017.    Source: TGA consultation

TGA Consultation: Therapeutic Goods Advertising Code

The TGA is seeking comments from interested parties on proposed changes to improve the Therapeutic Goods Advertising Code (the Code) and a possible framework for the advertising of pharmacist-only (Schedule 3) medicines to the public. Closing date 13th October 2017.    Source: S3 adverts     Editor’s note: See also Complementary Medicines Australia (CMA) detailed response: CMA submission

TGA Fees and Charges: Summary - From 1 July 2017

The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. The 2017-18 fees and charges schedule for non-prescription medicines applies to applications submitted to the TGA on or after 1 July 2017.    Source: TGA fees

TGA Consultation: Proposed Amendments to the Poisons Standard

The TGA is seeking comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Chemicals Scheduling (ACCS), the Advisory Committee on Medicines Scheduling (ACMS) and the Joint ACCS-ACMS. This consultation closes on 6 October 2017. (Please note in particular the proposal for the scheduling of “salts of boric acid”).   Source: Poisons standard

TGA Updates Manufacturing Principles for Medicines, APIs and Sunscreens

The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. The TGA maintains its GMP standards in line with updates issued through the PIC/S. Regular updates are necessary to maintain mutual confidence with regulators overseas and to promote quality assurance of inspections and harmonisation of technical standards and procedures with international inspection standards for the production and testing of medicinal products. This initial adoption of the PIC/S Guide to GMP is scheduled to commence on 31 December 2017 at which point, GMP inspectors will use the new Guide to GMP during inspections.    Source: Manufacturing principles

TGA Revises Pharmacovigilance Responsibilities of Medicine Sponsors

Pharmacovigilance is defined by the World Health Organization as the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems. The Therapeutic Goods Administration (TGA) collects and evaluates information related to the benefit-risk balance of medicines in Australia to monitor their safety and, where necessary, take appropriate action. This guidance sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA. It outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance best practice.  TGA has confirmed that only the Administrator of the EBS account can add the pharmacovigilance contact person and that agents (i.e. consultants) can’t do it on behalf of sponsors. New sponsors have 15 calendar days after they list their first product, to nominate their pharmacovigilance contact.    Sources:Pahrmacovigilance ; Responsibilities

TGA Recalls—

Ausganica Soothing Herbs Toothpaste: Ausganica Soothing Herbs Toothpaste is marketed as a herbal medicine that enhances oral health. It has been identified that Ausganica Soothing Herbs Toothpaste 130 g contains comfrey, an ingredient that is included in Schedule 10 of the Standard for the Uniform Scheduling of Medicines and Poisons because it is considered a substance ‘of such danger to health as to warrant prohibition of sale, supply and use’. Comfrey contains pyrrolizidine alkaloids, which are toxic substances that have been associated with liver damage and other health hazards.    Source: Herbal toothpaste

7-Day Slim Extreme capsules: the capsules contain the undeclared substance sibutramine.    Source: Slim chance

Body Con Plus capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein.    Source: Body con

Lax-Sachets: Lax-Sachets contain powder that, after being mixed with water, is taken orally to relieve constipation and treat faecal impaction. There is an error in the dosage/administration instructions printed on the back of the sachets. Following the incorrect instructions on the sachets will result in a larger volume and more dilute solution to drink.    Source: Lax information

TGA Reports on Outcomes of Advertising Complaints and Compliance Following TGA Intervention

This report lists the outcomes where the advertiser has taken specific action to address identified breaches of therapeutic goods advertising legislative requirements and is compliant at the date for which the complaint investigation was finalised. The advertiser's actions have been taken following TGA investigations into these complaints. All of these complaints were the subject of a complaint to the Complaints Resolution Panel (the Panel). They were referred to the TGA for follow-up action because the advertiser did not fully comply with the Panel's request to address breaches of the therapeutic goods advertising legislation.    Source: TGA advert reports

TGA Annual Performance Statistics Report: July 2016 to June 2017

Each year the TGA provides information on their regulatory performance through the Annual Performance Statistics Report and the Half Yearly Performance Snapshot. They also report annually on their performance under the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report.    Source: TGA annual report


RFA Breaking News

New Service From RFA Regulatory Affairs - New Product Development

Details at the bottom of this newsletter.


Complementary Medicines (“Dietary supplements”):

  TGA Launches New Advertising Hub and Online Complaints Form Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1…



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Cosmetics (& Household cleaning products):

  Accord Australasia Sets Up ‘WashWise’ – All You Ever Wanted to Know About Washing Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic…


Marketing News:

  When are ‘Naturals’ not Natural? When you’re in Aldi Products marketed by supermarket giant Aldi using the term "naturals" don’t need to be made of mostly natural ingredients if…


Complementary Medicines (“Dietary supplements”):

  Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 – Update The Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 was registered on the Federal Register of Legislation…


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