Technical Alerts

The TGA has recently published an updated web page in relation to Nitrosamine impurities in medicines which includes details on sources, limits and quality references and a number of information sources for sponsors, manufacturers and raw material suppliers.

Please read today's full technical alert for additional information and details for member consideration.

The TGA has published a web page outlining new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 1 July 2022 to 30 June 2023, and includes matters relating to unapproved goods, e-commerce supply of unapproved goods; COVID-19 or serious diseases; sports supplements; and medicinal cannabis.

In particular CMA has supported TGA deterring and addressing the unlawful advertising of unapproved therapeutic goods (goods not listed on ARTG when required) on e-commerce platforms to Australian consumers. CMA supports monitoring and deterring the supply of illegal and unauthorised therapeutic goods in Australia, including via representation on the Therapeutic Goods Advertising Consultative Committee (TGACC), which identified that the supply of unapproved therapeutic goods that advertised non-compliantly on e-commerce platforms presents a risk to Australian consumers and industry.

This technical alert provides a summary of these TGA compliance priorities and includes additional information and resources where applicable or relevant, for member consideration. 

The TGA has published Guidance on applying the Advertising Code rules on their website.

From Today, July 1 2022, advertising for therapeutic goods that can be advertised to the public must comply with the requirements in the Act and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

Parts of the Guidance are available in Word and PDF format until searchable webpage guidance resources are published on the new TGA website.

Please read today’s full member alert for more information and details.

The TGA will be conducting targeted compliance reviews of selected listed medicines that contain Andrographis paniculata to ensure the presence of required warning statements. 

There are approximately 109 medicines containing Andrographis paniculata currently listed on the ARTG.

This technical alert provides more details, including a recap of requirements and a number of resources providing further contextual information.

Today's alert for members contains an assessment of the recently published Listed medicines Evidence Guidelines; a summary of CMA responses and outcomes; and a discussion of changes and issues for members to be aware of.

A full comparison highlighting the changes between the final published guidelines and the draft consultation paper is also linked for members.

We appreciate and welcome your ongoing member feedback and insights.

The end of the requirement for formal pre-approval of therapeutic goods advertisements in June 2020 was the result of a long sought after approach by CMA and our industry members, as part of the review of Medicines and Medical Devices Regulations (MMDR), to reduce unnecessary red-tape and create an increased self-regulatory approach to advertising.

The TGA expect compliance with advertising legislation including the Therapeutic Goods Advertising Code (as updated from time to time), but do not require that a third party service provider assess advertisements for compliance. However, since the abolition of the therapeutic goods advertising pre-approval requirements, some advertisers (such as retailers and third party websites) choose to request that other advertisers (such as medicine sponsors) use a third party review to help ensure the compliance of proposed advertisements across shared advertising platforms.

In these situations, please be aware that the TGA does not mandate, require, nor endorse any particular review service, consultants or vetting services. The TGA have stated that they undertake their role with impartiality, and recognise that the best outcome for advertising compliance includes equitable communication and engagement across all their stakeholders.

In summary, members should be aware that there are various avenues available to advertisers for a voluntary third party review of compliance of advertisements.

CMA have a list of highly experienced regulatory affairs consultants included on the CMA Regulatory Affairs consultants webpage, whom can expertly help advertisers assess advertisements for compliance against legislation including the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

Today's Technical Alert provides information for sponsors in relation to receiving TGA Notices of "Conditions of Listing". 

CMA understands that the sending of the Notices by the TGA that are signed by a Delegate is a formalisation of applying the conditions of listing.

Receiving a Notice should not remarkably affect sponsor activities, because the Notices contain the standard ongoing conditions of listing that sponsors are already familiar with as they are included on ARTG records at the time of listing.

Please read the full tech alert for more details, including targeted industry consultation on moving the conditions into a Determination (legislative instrument) at a future date.

This information may be of interest to:

-Research and academic institutions conducting clinical trials

-Sponsors and other members sponsoring or involved in clinical trials

The TGA will provide an overview of the new Guidance for GCP Inspection of clinical trial sites for investigational biologicals and medicinal products via an online webinar, to be held on Tuesday 28 June 2022, 1pm-2pm. Click here to register.

This webinar follows the recently published Guidance on the TGA website for Good Clinical Practice (GCP) inspection of clinical trial sites for medicinal products. The guidance describes how the TGA prioritise and schedule GCP inspections; the kinds of inspections the TGA might conduct; the inspection process, and how the TGA report and follow-up on inspections.

While CMA is aware that currently the TGA prioritise inspections for high risk products such as prescription medicines or biologicals, meaning CM trials may not be inspected, the information at the webinar and in the guidance is nonetheless valuable for those conducting trials.

CMA recommends attending the webinar that if you are conducting or sponsoring clinical trials for complementary medicines. Please also see CMA’s 28 April technical alert for more information.

TGA's Industry- Only Consultation on Proposed Update to limited aspects of TGO 92 Labelling Order - Medicine Name presentation & 'distinguishing marks'

*Privileged Government information for industry members only: Not authorised for copying, distribution or publication outside of your company*

The following information may be of interest to:

- Sponsors / brands, particularly those with s9(2) s14/14A consents from TGA

- Any member interested in how medicine name and labels are presented for supply

- Manufacturers releasing for supply

Sponsors of complementary medicines currently have labelling restrictions in section 9(2) of the TGO 92 on how medicine names are presented in combination with distinguishing marks (may include registered trademark, a graphic image, icon or logo, a brand name, slogan or tagline), within or adjacent to the medicine name, which occurred as part of changes to TGO 92 that was introduced between 2016-2020.

This means that brands may not be able to be presented optimally for commercial purposes, or existing formats may be non-compliant with the labelling standard.

CMA has been working with the TGA for several years to help ensure that medicine name presentation can be preserved for medicine sponsors to ensure trademark use, label presentations, and protect export considerations. Many CMA sponsors have been provided consent to supply goods with existing medicine name presentation, since TGO 92 took full effect in 2020.

The consultation newly released is intended to provide greater flexibility to industry on presenting labels that include distinguishing marks within or adjacent to the medicine name, provided that overall consumer identification of the product for recall or other purposes is not unduly affected. This is intended to ensure that those with existing s14/14A "consents to supply" for non-compliance with TGO 92 s9(2) will - in most, if not all circumstances - be considered compliant and therefore no longer need to obtain these after the update is implemented. This is intended to occur prior to the current expiration date of the notices on 31 August 2021.

Please see details of the consultation in today's member alert.

CMA appreciates all the member feedback on this issue to date and looks forward to finalising these issues with you in this industry consultation from TGA. We encourage members to consult with their legal departments on the proposed updates to ensure needs will be met.

Please contact Lucy.Lang@cmaustralia.org.au and technical@cmaustralia.org.au with your feedback and responses to CMA preferable by COB Friday 15 July. 

Members who received invitation to comment by the TGA have until COB Tuesday 19th July to respond to TGA.

Evidence Guidelines for Listed Complementary Medicines: Version  4.0

The TGA have finalised and published the updates Evidence Guidelines, Version 4 June 2022; How to demonstrate the efficacy of listed medicines is acceptable. 29 submissions were received to the consultation:

- Industry Groups: 2

- Regulatory agents: 3

- Health care professional groups: 4

- Research/Academic Institutions: 3

- Individuals: 1

- Consumer groups: 0

The TGA have thanked CMA and members for the valuable contribution provided on this mutually important guidance and provided that all feedback has been carefully considered. Further information has been provided by the TGA on the purpose of the guidelines; the legislative basis and expectations; what they consider a critical appraisal, and evidence sources for traditional medicines.

The updated guidelines also make it clear that the guidelines are not mandatory requirements but rather show sponsors what a TGA delegate considers in a compliance review and what will more likely result in a successful compliance review outcome.

Further analysis for members on final outcomes will be published for regulatory and technical staff by CMA technical alert in coming days.

Feedback from members, both now and on an ongoing basis as TGA compliance reviews occur, is strongly welcomed at technical@cmaustralia.org.au