GMP for Overseas Manufacturers of Medicines and Biologicals During the COVID-19 Pandemic

The Therapeutic Goods Administration has updated information for foreign manufacturers and the remote GMP Inspections of their facilities. Manufacturers of medicines and biologicals are routinely inspected using a risk-based approach against the appropriate Manufacturing Principles. Following the suspension of on-site inspections due to COVID-19 restrictions, the TGA has developed new arrangements to allow continued and flexible oversight of licenced domestic manufacturers by performing remote GMP inspections. The domestic program demonstrated that it would be possible to replicate this approach for overseas medicine and biological manufacturers. However, it is recognised that broadening this program may bring additional challenges and the same number of manufacturers cannot be inspected using this approach. From July 2020, the TGA will begin the remote GMP inspections program for some overseas manufacturers.    Source: COVID-19 GMP inspections    (Also refer to: Expectations for overseas manufacturing sites hosting remote inspections during covid-19 pandemic )

*** Please contact RFA Regulatory Affairs if you need assistance with your GMP ***

System for Australian Recall Actions

The System for Australian Recall Actions (SARA) provides consumers, health care professionals, sponsors, wholesalers, hospitals, and retailers with access to information about recall actions occurring in Australia for therapeutic goods. The Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. In July 2020, the TGA completed an enhancement to SARA database's search facility. Users are now able to download search results of summary recall data in editable, MS Excel format, in addition to the existing PDF reports. This project was undertaken in response to requests from a range of external stakeholders to provide better access to TGA recall data.    Source: SARA database

Regulation of Thermometers and Other Temperature Measuring Medical Devices for COVID-19

Any temperature measuring product for use on humans, for the intended purpose of screening potentially febrile individuals during a pandemic, meets the legal definition of a medical device and is required to comply with the Australian regulatory requirements, including listing in the Australian Register of Therapeutic Goods (ARTG), before importing or supply. Should the product not be intended by the manufacturer for a medical purpose, suppliers and retailers cannot represent the product as a medical device and cannot promote the product for the purpose of screening potentially febrile individuals. Additionally, it is an offence to advertise to any person a medical device for purposes other than the manufacturer's intended purpose. Before sponsors submit an application for inclusion of a thermometer or any other temperature measuring medical device in the ARTG, they should establish the classification of their product. An online classification tool is available to help determine the classification of a particular device.    Sources: COVID19 medical device & Medical device classification tool 

TGA Consultation - Therapeutic Goods Order 106 - Data Matrix Codes and Serialisation of Medicines

The TGA is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. Data matrix codes are an important first step towards a medicine traceability system. To make sure the standard is clear, meaningful and fit for purpose, the TGA is seeking feedback on its suitability and potential impacts. This consultation closes 13 August 2020.  Source: TGO 106 consultation

Review of Listed Medicines with Traditional Indications

Over the remainder of 2020, the TGA will be initiating targeted compliance reviews on listed medicines that are based on TCM, Ayurveda or other traditional paradigms. If you are a sponsor of a listed medicine with traditional indications, you are encouraged to re-evaluate the evidence you currently hold, particularly in relation to the active ingredients in your products and their dosages; and also to reconsider the indications made for your medicines with reference to the ‘Evidence guidelines for listed medicines’.    Source: Traditional medicines review

Pharmacovigilance Inspection Program Risk Assessment Survey

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete and will remain open until 30 September 2020. The TGA's PVIP Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance processes, inspection history and compliance with Australian pharmacovigilance legislation and guidelines and will serve as a tool to help prioritise and schedule pharmacovigilance inspections. Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey. Medicine sponsors that do not complete this survey will be assigned the highest survey risk score. Please also note that the survey questions relate only to sponsor’s medicines (not medical devices or biologicals) in the ARTG. This includes all listed, registered and provisionally registered medicines.    Source: Pharmacovigilance inspection program

End of Advertising Pre-Approval Scheme: Questions and Answers

Up until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' required approval under the Therapeutic Goods Regulations 1990 before they could be published or broadcast. This advertising pre-approval scheme has been stopped in favour of a more self-regulatory regime. Please note, all advertisements for therapeutic goods are still required to comply with the therapeutic goods regulatory requirements. This helpful Q & A page responds to sponsor queries regarding the new scheme: Therapeutic advertising Q&A

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TGA Guidance on Directing Advertising Exclusively to Health Professionals

This information explains how to direct therapeutic goods advertising exclusively to health professionals so that the consumer advertising requirements do not apply. Any advertisement for therapeutic goods that is accessible by consumers must meet the Act's requirements for advertising to consumers, even if the goods are not available for purchase by consumers or you think the content clearly targets health professionals.    Source: Ads for health professionals

Consent to Import, Supply or Export Therapeutic Goods That Do Not Comply with TGA Standards

Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia and it is an offence to import, supply or export therapeutic goods that do not comply unless an exemption is given. Consent to not complying with an applicable standard will not be given unless the TGA is satisfied that the safety, quality, safety and efficacy and/or the safe and effective use of the product will not be adversely affected. Special processes have been set up for medicines affected by COVID-19 delays.   Source: Non-standard consent

Cochlear Calls for Low-Risk Health Apps to be Exempt from TGA Register

Australian company, Cochlear Ltd. has called for some low-risk health apps to be exempt from the therapeutic goods register, joining a push by medtechs, including Roche Holding AG, for greater certainty on the regulation of medical and healthcare software. Over the past two years regulators have been grappling with the oversight of medical software amid a boom in healthcare apps, clinical products and health trackers. Last year a new set of requirements was established that categorised software based on the level of risk the product poses to patients. In June 2020, the government flagged it would delay the rollout of new medical device regulation, including for software, until next year due to COVID-19. It is not clear which health app products are set to be excluded or exempted from regulation, however. In March the TGA asked businesses where they thought the line should be drawn.    Source: Emma Koehn, SMH Health apps exemptions

TGA Issues Fines of Nearly $1.8 Million for Alleged Illegal Activity In 2019-20

The TGA has taken strong action against alleged illegal import, manufacture, supply and advertising of therapeutic goods in Australia during 2019-20 when 187 infringement notices were issued for alleged breaches of the therapeutic goods legislation, totalling almost $1.8 million. In the same period, the TGA pursued civil court action against three companies, with the Federal Court of Australia ordering one company to pay the Commonwealth $10 million for breaches of therapeutic goods advertising requirements. A further five criminal matters were referred to the Commonwealth Department of Public Prosecution.    Source: TGA acts on lawbreakers    (Please see also TGA infringement notices ; Database of TGA listed medicine compliance review results   and this example case: False evidence claim )

Pfeffer Contracting Fined $25,200 for Alleged Advertising Breaches in Relation to COVID-19

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Pfeffer Contracting Pty Ltd for alleged unlawful advertising in relation to COVID-19. Advertisements on the company's website for a test kit and surgical masks allegedly referred to COVID-19. Under the Therapeutic Goods Act 1989, any claims or references to COVID-19 (and related terms) about therapeutic goods are restricted representations. A restricted representation refers to a serious form of a disease, condition, ailment or defect. The use of restricted representations in advertisements for therapeutic goods is unlawful without an approval or permission from the TGA.    Source: Pfeffer fail

Lorna Jane Fined for Alleged Advertising Breaches in Relation to COVID-19 "Anti-Virus Activewear"

The TGA has issued three infringement notices totalling $39,960 to Brisbane clothing company Lorna Jane Pty Ltd for alleged unlawful advertising in relation to COVID-19. Lorna Jane allegedly claimed, on its website, that its 'anti-virus activewear' prevents and protects against infectious diseases, implying it is effective against COVID-19. The TGA alleges that Lorna Jane represented its 'anti-virus activewear' for therapeutic use and therefore believes that it is a therapeutic good within the meaning of the Therapeutic Goods Act 1989. Therapeutic goods, including advertising, are subject to the regulations administered by the TGA. The advertisement referred to therapeutic goods that were not included in the Australian Register of Therapeutic Goods (ARTG). This is required before they can be lawfully supplied or advertised in Australia.    Source: Therapeutic clothing fail

Arborvitae Health And Wellbeing Fined $12,600 for Alleged Advertising Breaches in Relation to COVID-19

Arborvitae Health And Wellbeing allegedly claimed, on the company's website, that Arborvitae Health and Wellbeing Supplement (Arborvitae) is an effective treatment for COVID-19. Under the Therapeutic Goods Act 1989, any claims or references to treating COVID-19 (and related terms) are restricted representations.    Source: Arborvitae advertising fail

Strapit fined $37,800 for alleged advertising breaches in relation to COVID-19

The TGA has issued three infringement notices today totalling $37,800 to Melbourne-based company Strapit Medical and Sports Supplies Pty Ltd, for alleged unlawful advertising in relation to COVID-19. Strapit Medical and Sports Supplies allegedly claimed, on its website, that a Zafe Zone product for use on surfaces and skin killed COVID-19, without having the necessary authorisations from the TGA.    Source: Strapit hit with fine

Zafe Zone fined for alleged advertising breaches for disinfectant products in relation to COVID-19

The TGA has issued three infringement notices today totalling $39,960 to Melbourne-based company Italian Princess Coffee Brands Pty Ltd (trading as Zafe Zone), for alleged unlawful advertising in relation to COVID-19. Zafe Zone allegedly promoted its disinfectant as effective against coronavirus, without having the necessary authorisation from the TGA.    Source: Zafe Zone fined

TGA Safety Advisories-

AuLion Energy Candy: The candies contain the undeclared substance sildenafil.    Source: AuLion energy candy

Fostering innovation in Australia’s Listed Medicines’ Industry

The Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020, which amends the Therapeutic Goods Act 1989, was passed by both houses on 25 June. This amendment introduces a mechanism to protect new research data for low risk complementary medicines that have proven novel efficacy claims. This represents regulatory innovation that the sector has been striving to achieve for many years.  The usual intellectual property patenting process is not as readily amenable to protect research investment for ingredients that are already in the public domain. “This extraordinary regulatory reform represents one of the most exciting improvements in the complementary medicine landscape that we have witnessed in decades," said Professor Alan Bensoussan, Director, NICM Health Research Institute.     Source: LM regulatory innovation


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