Technical Alerts

The TGA has launched:

- New functionality within the ELF system for listed medicine applications;

- A new online application system for AUST L(A) listed assessed medicines;

- An updated User Guide for online applications of AUST L and L(A) medicines.

The TGA have provided an early copy of the final, NEW Standard for Tablets, Capsules and Pills, the "TGO 101". This replaces the TGO 78 as of next Sunday, 31 March 2019. Some new requirements have a 2 year transition period.

A copy of the final version of the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG0 101) Order 2019 is not yet published on the TGA website but is linked to within this alert.

We recommend members familiarise themselves with the changes and new requirements as outlined in the document and summarised in this Technical Alert.

The Department of Agriculture and Water Resources are experiencing delays in assessing import permits for a variety of animal and biological product import permit applications, including those that affect complementary medicines.

Details of processing times and tips for businesses to improve application processing timeframes and outcomes are included in the alert here.

The second list of permitted indications has been published by the TGA, titled the Therapeutic Goods (Permissible Indications) Determination (No 1.) of 2019.

This second Permissible Indications Determination includes new indications for sponsors, and other changes, notably re-instated label warning statements.

The TGA have also published additional information on the outcomes of the permissible indications consultation, including a list of some of the industry-proposed indications from the consultation that are not currently included in the Determination.

More details for sponsors, including key changes for sponsors, are here.

There has been a change of leadership at the National Institute of Integrative Medicine, with CMA commending the inaugural CEO, Mr Steven Bunce on his commitment and leadership in growing this high quality integrative medicine and research facility.

The TGA have announced an update to the Permitted Indications Determination, with the second version being released this month. The new Determination features new permitted indications, some changes to indications, and changes or additions to label advisory statements. For more information, please read our technical alert here.

The TGA is updating the Evidence Guidelines for Listed Medicines in two phases in 2019:

Phase 1: An administrative update (newly released today) to reflect permitted indications.

Phase 2: Review of the guidelines to increase clarity (but not change the levels and kinds of evidence), with public consultation in 2019.

More information here.

In response to CMA's efforts, the Department of Industry, Innovation & Science have opened ataskforce investigating the effect of the changes in "Made in Australia" policy to the complementary medicines sector.

The taskforce has developed a survey specifically seeking commentsfrom Australian businesses directly involved in producing vitamins, minerals or supplements, and/or those selling these products under a private label or brand.

CMA strongly encourages members to assess business impacts and participate in the survey. More information and links to the survey here.

Today's technical alert includes information on the recent update to the GMP Clearance Guidance (v 18.1); Advertising Q&As; Curcuminoids naming update; and SME workshop for Adelaide, here.

The TGA has released an important Public Consultation to remake the TGO 78 that will set the manufacturing standards for Tablets, Capsules and Pills for the next foreseeable decade. Traditional Chinese Pills are being incorporated into the new TGO with a 12 month transition.

Although many requirements remain unchanged, there are some significant changes including:

A) The ability to choose whether to apply the Australian specific requirements for compliance, or to use an applicable monograph for the specific finished tablet or capsule from the BP, EP, or USP (with additional specific requirements).

B) Regardless of which standard is chosen, the TGA are proposing that all listed and registered tablets, capsules and pills will have applicable impurity limits, specifically, Arsenic, Lead, Cadmium, Mercury, and residual solvents.

Submissions close on 8 February and the remade Order will be in place by 31 March 2019.

More information and details are included here.

Please find the latest technical alert here, which includes:

- CMA Annotated version of the Advertising Code (No. 2) 2018 for member use

- Other advertising updates, including TGA suggested social media policy and upcoming webinar

- Food Regulations guidance, "Getting Your Claims Right"

- NZ Medsafe alert on Artemisia annua products