Technical Alerts

The TGA are implementing an update to ARTG summaries for listed medicines for both sponsors and the public. this update will ensure that when herbal ingredients and active proprietary ingredients are used in listed medicines, the information about the active ingredient will be displayed more clearly. 

The changes are set to be implemented over the next few weeks are likely to be released by the end of December. Please read today's member alert for more information.

As part of the wider reform agenda for the food regulatory system the Department of health is conducting a consultation on Consistency of Food Regulatory Approaches

Stakeholder advice is being sought on areas of inconsistency in food regulation and the impacts of this on businesses and regulatory outcomes, including adverse regulatory outcomes and/or creating adverse outcomes for food businesses. Stakeholder advice is also sought on areas of duplication between the food regulatory system and related regulatory systems, such as therapeutic goods.

Responses to the consultation, which closes on 18 December 2020, can be submitted via an online survey.

Please read the full technical alert for more details.

Members often seek information on clarification around GMP considerations for for active ingredients or processed materials that are used in the manufacture of complementary medicines. Today’s technical alert provides recent clarifying information relevant to those considerations. Please read the full alert for more details.

Today's technical alert provides important information on a technical item for sponsors, consultants and manufacturers to be aware of.

CMA encourages members to read the alert and to share the information with relevant members throughout your individual organisation.

Today's technical alert includes important information for sponsors in relation to mandatory pharmacovigilance requirements and best practice TGA expectations. 

Our member only alert, available here via member login, includes all of the information contained in the public alert below, in addition to other information tailored specifically to help members reduce regulatory burden and other member only information.

The public alert is available for open distribution to all members of industry to ensure that all have access to timely reminders for minimum compliance requirements which help to uphold industry safety and quality. This public link can be shared.

The Government has acknowledged that Australian manufacturers face a challenging business environment due to the COVID-19 pandemic, and by working with industry, aims to create a competitive business environment, build scale and boost supply chain resistance. Announcement of a $1.5 billion investment in a Modern Manufacturing Strategy has been made, with funding available for eligible manufacturers for key manufacturing initiatives.

For more details on the Strategy and eligibility criteria, please read today’s member alert. 

Subscribe for updates on the Strategy by completing the linked form on the Department of Industry, Science, energy and Resources website.

The Competition and Consumer Amendment (Australian Consumer Law - Country of Origin Representations) Bill 2020 (the Bill)was debated and passed  the House of Representatives on the 27th October 2020.

The purpose of the Bill is to amend the Competition and Consumer Act 2010 (the CCA) to widen the definition of what constitutes the ‘substantial transformation’ of goods for the purposes of ‘safe harbour’ provisions relating to country of origin representations - such as ‘made in Australia’ claims.

The amendment lays the foundation for Australian made complementary medicines to have robust access to a safe harbour Australian origin claim and to the 'Australian Made, Australian Grown' logo. This bill marks the next step towards implementing the government's commitment to establish strong country of origin labelling laws for Australian made complementary medicines.

For more information on the progression of Country of Origin Labelling (CoOL), please see today's member alert.

Following a plan made by the Australia and New Zealand Ministerial Forum on Food Regulation in November 2019, a review of the food regulatory system including the Food Standards Australia New Zealand Act 1991 is occurring to ensure it remains strong, robust and agile into the future.

Stakeholders are strongly encouraged to respond to the consultation which is by online survey, and asks key questions about the regulation of foods, including items of key interest to you, including issues regarding the food-medicine interface and the possibility of regular, more holistic reviews of food standards. For more information please see today’s technical alert.

Responses to the consultation can be done via an online survey until 16 November 2020. 

It is not necessary to complete the survey in one sitting. You can save your answers and come back later.

The TGA have recently issued a safety advisory for listed medicines containing herbal ingredients from the Artemisia species after becoming aware of studies that indicate certain Artemisia species may pose a risk during pregnancy.

Though the TGA have stated that no adverse event reports related to the use of listed medicines containing Artemisia species during pregnancy have been received, an investigation into the level of risk associated with different Artemisia species is being conducted.

For more information about the safety advisory for Artemisia species, including next steps, likely outcomes, and sponsor obligations, please see today's technical alert.

The TGA have recently issued a safety advisory for 'very rare' reactions to Valeriana officinalis (Valerian) following 15 reports of liver injury since 1983. Most cases of reported liver damage resolved after the use of Valerian was discontinued. The current alert and investigation was triggered by an adverse event in 2019.

For more information about the safety advisory for Valerian, including next steps, likely outcomes, and sponsor obligations, please see today's technical alert.