Technical Alerts

Today's tech alert provides information for sponsors on the TGA’s new published Checklists for 9D(1)(a) requests to change (vary) an ARTG entry.

The new checklists are designed to be used by a sponsor (or agent) who wants to request the following changes to their medicine's ARTG entry under paragraph 9D(1)(a) of the Act: the checklists will assist sponsors who want to make the following changes:

1. Correct an omission or mistake made at the time the medicine was listed; and/or

2. Replace a Proprietary Ingredient (PI) with the individual ingredients included in the PI’s formulation (where there is no change to the formulation, ingredients or quantity).

This tech alert also clarifies the TGA’s interpretation of ‘separate and distinct’ with regard to Section 9D applications, and provides additional information to assist sponsors in determining the circumstances under which their application to change (vary) an ARTG entry may be eligible.

Examples of what are potentially eligible and ineligible for section 9D(1)(a) applications are included at the end of this alert.

Please read the full alert for all information and details.

The TGA has published outcomes of the consultation on proposed low-negligible risk changes to the Permissible Ingredients Determination, which occurred in August - September 2023.

These changes relate to:

New warning statements for - 

- Curcuma species/curcumin (turmeric)

- Camellia sinensis (green tea)

Changed requirements for - 

- soy phosphatidylserine

- Kakadu plum

New Adverse Event Management System launched

In response to feedback to the TGA's 2022 sponsor survey on Improving access to medicine adverse event data, the TGA have now finalised their launch of a new search functionality, the Adverse Event Management System (AEMS).

Sponsors can now access TGA-held adverse event reports relevant to their own medicines to:

- search for reports

- filter results using multiple data attributes

- download de-identified Public Case Detail (PCD) and Case Line Listing (CLL) reports for inclusion into your own pharmacovigilance systems.

Sponsors can use the feature through the AEMS portal or TGA’s Business Services Sign In using your TBS account. 

As specified in the AEMS guidance for sponsors, once a new TBS user account is created, it can only be used to access AEMS the next day. See New medicine Adverse event search for sponsors. 

Electronic notification form updates

Following the update to the Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements guidance in August, the TGA have made the following improvements to the medicine safety issues electronic notification form in response to stakeholder feedback.

1. A secondary email address field - an email address provided in this field will also receive a copy of the submitted safety issue notification.

2. A preview page - this will allow the reporter to review the details of their safety issue notification as the final step prior to submission of the form.  

TGA Webinar: Understanding changes to the Pharmacovigilance (PV_ Guidelines

The TGA held 2 webinars in August, outlining and explaining the changes contained in version 3.0, with the opportunity for Q&A. A third and final TGA webinar is now set for Thursday 14 December at 1:00pm AEDT and will be a further opportunity for Q&A on the changes to the PV guidelines. The TGA are inviting stakeholders to submit questions prior to the webinar, as these will be addressed first and questions may not be accepted live during the webinar. Register for the webinar and submit questions here.

Reminder - implementation period

The 6-month implementation period of the changes to the PV, during which adoption of the changes included in this update are strongly encouraged but not mandatory and will not be inspected against, will conclude on Wednesday 31 January 2024. During this time, the TGA expect significant safety issues (SSIs) to continue to be reported. The TGA has advised that changes to reporting requirements will not be enforced or inspected against until February 2024. All existing requirements in the PV Guidelines are excluded from this implementation period and will continue to be enforced.

Recently, CMA met with representatives of the New Zealand Ministry of Health as part of our representation on the ComTech forum, to discuss the progress and implementation of the new regulatory scheme for Natural Health Products in NZ, and how Australia and CMA can be involved in the process, supported by our lengthy experience in a medicinal regulatory scheme for natural and complementary medicines.

The New Zealand Therapeutic Products Bill received Royal assent and became the Therapeutic Products Act 2023 (the TP Act) on 26 July 2023. Most provisions in the Act will not come into effect until 1 September 2026 at which time transition arrangements to the new regulatory scheme will begin. Under the Act, natural health products (NHPs) will have their own regulations and a new regulator. 

Please read CMA's full member alert for more information and details. 

The TGA has today published a NEW web page: Regulation of sport supplements in Australia: information for importers and sellers. The guidance provides information for stakeholders including:

- which Sport supplements are [likely to be] foods

- which sport supplements are [likely to be] therapeutic goods;

- how and why sport supplements are regulated in Australia;

- what you need to know to comply with therapeutic goods laws.

The new web page also includes a printable Fact Sheet on important information for importers and sellers regarding the regulation of sport supplement products in Australia.

The above information, and CMA’s previous 17 October 2023 public alert covering this topic, are free to be distributed to any industry participant.

Member questions or concerns can be directed to technical@cmaustralia.org.au

Today's tech alert provides members with an update on the following:

Update on PV Guidelines version 3.0: Additional FAQs published; Webinars

- The TGA has compiled a document of frequently asked questions (FAQs) for the new version 3.0 PV Guidelines in response to webinar questions.

- The recording and slides of the first TGA webinar are now available.

- The final TGA webinar is planned for mid-December and will provide a further opportunity for Q&A. Registration information for this webinar will be distributed by the TGA in the coming weeks.

New adverse event search function and related guidance

- The TGA are seeking feedback on the new Adverse Event Management System (AEMS) search function and guidance prior to publication, which is now available for sponsor testing.

The search functionality allows sponsors to access TGA held adverse event data relevant to their products.

Members are invited to provide feedback on critical issues with the new functionality, including any data discrepancies, as well as comments on the draft guidance.

Please read todays full alert for more information and details, including how to access the new AEMS search function. 

CMA has become aware of some wider industry confusion over the transition for sports supplements that are therapeutic goods, expected by 23 November 2023.

CMA has produced an Industry alert covering this topic about examining goods at the food-medicine interface, for both members and non-members, in the interests of increasing understanding for all industry members to further promote and enhance industry compliance, reputation, and commercial ease of practice.

The industry alert is available publicly. Either the link, or the un-amended document in full, may be distributed to any industry participant.

Thank you for your ongoing support!

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023, has been approved by the TGA and entered onto the Federal Register of Legislation here. This instrument is made under section 26BB of the Therapeutic Goods Act 1989 ('the Act') and repeals the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2023.

The Determination has been updated to include:

Two new ingredients with exclusive use provisions for two years:

- Cyclocarya paliurus leaf dry extract

- calcium fructoborate tetrahydrate 

Extension for use of one ingredient:       

- sugar cane wax alcohols

Removal of the following ingredients where the substance in each instance is covered by a single entry:

- cresyl isobutyrate

- dodecanal

- galbanum phenol

Removal of the following entries with invalid names that do not refer to a specific substance:

- 6-methyl-2-buten-3-ol-2

- Acetyl

- mandarinal 32048

- myrtle essence max

- tripal

Please today’s tech alert for more details, including a comparison table of all changes.

The TGA has published the Scheduling interim decision on amygdalin and hydrocyanic acid, and a public consultation on the interim decision is now open, closing 2 November 2023. 

After considering the submissions from 36 entities, including CMA (10 submissions were opposed to the proposal) and advice of the joint Advisory Committee on Chemicals and Medicines Scheduling (ACCS- ACMS), the Delegate of the Secretary of the Department of Health and Aged Care has made an interim decision to not amend the current Poisons Standard in relation to amygdalin  and HCN.

Members are encouraged to read today’s technical alert for more information and details, including a summary of the Delegate’s reasons, relevant scheduling history, and how to respond to the interim decision consultation.

CMA are pleased to share with our members some of the work that has been keeping us busy over recent months. CMA have submitted responses to a variety of consultations affecting various aspects of the complementary medicines sector, a summary of which is outlined below.

These submissions reflect our shared and ongoing commitment to the success of the sector. Our collective efforts as an industry continue to demonstrate dedication and commitment in advocating for positive change. We thank our members for their ongoing engagement. 

Please ensure you are logged in to the CMA website to view CMA’s submissions.

Turmeric, Curcumin, Green Tea and other ingredients (TGA)

- CMA submission to the TGA consultation: Proposed changes to the Permissible Ingredients Determination - low negligible risk: Curcuma species/curcumin; Green Tea; Soy-phosphatidylserine enriched ingredients; Kakadu plum - 14 September 2023. Link. 

Probiotics Regulations (TGA)

- CMA Submission to the TGA consultation: Guidelines for the Quality of Listed Probiotic Medicines - 8 September 2023.Link.

Sustainability & Environmental Product Claims (ACCC)

- CMA Submission to the ACCC consultation on Environmental and Sustainability Guidance - 15 September 2023. Link.

National Health and Climate Strategy (Dept. Health)

- CMA Submission to the Department of Health and Aged Care National Health and Climate Strategy - July 2023. Link.

Formulated supplementary sports foods (FSANZ)

- CMA Submission to the FSANZ review of Nutrition and Health Claims for formulated supplementary sports foods. Link.

Labelling of Complementary Medicines(TGA - early, non public consultation)

- CMA Submission to the TGA Targeted TGO 92 consultation: Australian medicine labelling rules: Targeted consultation on priorities for future improvement to TGO 91 and TGO 92 requirements. Link.

Labelling of Complementary Medicines that are large dosage forms (TGA early, non public consultation)

- CMA Submission to the TGA Targeted TGO 92 consultation*: Australian medicine labelling rules: Large solid oral dosage forms intended to be swallowed whole* Link.

*Please note, CMA’s response to the TGA Targeted consultation on TGO 92 will not be published on the TGA website, or made publicly CMA. This is strictly for member information purposes only and may not be re-published or reproduced.