Technical Alerts

Please see today's technical alert in Word or PDF about the consultation on proposed changes to ingredients in the Permissible Ingredients Determination, including a member feedback form for your comments.

The TGA have advised that enhancements have been made to the TGA Business Services Portal on the TGA website to enable publication of approved Product Information (PI) and consumer Medicine Information (CMI) documents for some non-prescription medicines (and some biologicals).

PI and CMI documents for non-prescription medicines, including some registered complementary medicines, which meet the requirements, will have the (non-mandatory) option of online lodgement in TBS from today, 24 August 2020. Documents lodges online, when approved, will also become available for the public to access online via the TGA website. 

Please see today's technical alert for more information on the requirements fro lodging online PI and CMI documents. 

We are very pleased to announce the success of CMA's down-scheduling application to make herbs containing (beta) arbutin, such a s Bearberry, Damiana and others, again more available for use through significantly lower restrictions.

For more information including the effect of this decision on herbal medicines, dates, a brief background and other relevant details and information, please read today's member alert on arbutin changes. 

A new Permissible Ingredients Determination (No. 3) 2020 has commenced with one new ingredient and changes to existing ingredients, including reduced regulatory requirements in some instances.

This Technical Alert (available in Word or PDF) contains a detailed list of changes with a Notes field for sponsors to use to assist in identifying the changes relevant to products, as part of a table which includes:

- Each new or changed ingredient

- The original (previous) requirements that applied

- New (amended) specific requirements.

In particular, the amendments contain notable clarifications for products with herbs containing levodopa as a mandatory component.

Members interested in Fallopia multiflora (He Shou Wu or Fo-Ti) should also refer to today's alert.

There have been changes and updates and clarifications to the Therapeutic Goods legislation, the Australian Regulatory Guidelines for listed medicines, and the User Guide, in relation to new substance applications for listed medicines.

Notable changes include:

- Mandatory data requirements for preliminary assessments (under development)

- How the TGA will manage duplicate applications for the same new ingredient

- Clarification regarding types of substances that may be applied for, and naming applications prior to new substance applications

- More information on the evaluation phase of the application and the recommendation or refusal of an application

- Additional clarification for market exclusivity arrangements

For details and context please see the attached technical alert. We welcome your ongoing feedback in relation to these application processes and guidance documents.

The Australian Government has released and responded to the Independent Review of the TGA'S Advertising Framework, conducted by Rosemary Sinclair AM.

The background and twenty-two outcomes are summarised into the key takeaway messages for our members here, which is relevant to sponsors, retailers, consumers, and all who engage with therapeutic goods advertising.

Australia are participants in an international regulatory forum with Europe, Canada, USA, China and other countries in Asia and South America, which is currently examining liposomal products in relation to:

- Harmonisation of regulatory requirements internationally 

- Research needs

- Quality standards and reference materials

Feedback is sought - please see today's technical alert.

The TGA have published new Advertising guidance in relation to differentiating between consumer level advertising and advertising directed exclusively to health professionals, including where advertising may or may not need to be restricted. This can be particularly relevant to practitioner only companies, and those who conduct any kind of advertising or non-advertising (factual information) activities in relation to complementary medicine substances and products. More information available here.

This important technical alert for members includes information relating to substances eligible to be included in listed medicines and the regulatory framework.

Today's technical alert contains important information, context and considerations fro industry members in relation to:

- The TGA targeted compliance reviews of traditional indications

- All post market compliance reviews of listed medicines