Technical Alerts

The Therapeutic Goods Legislation Amendment (Fees) Regulations 2021 is now in effect.

These regulations amend the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to increase the fees set out in those respective regulations by 1.05 per cent, for the financial year 2021-22.

Please read today’s technical alert for more information on how the updated charges will be applied, including a summary of CMA’s response to the fees and charges consultation.

FSANZ have released two calls for comment:

1. Review of standard 2.9.1 Infant Formula- open 21 May 2021 to 7 July 2021

2. A new way to measure fibre content in food- open 21 May 2021 to 22 June 2021

Please read today’s technical alert for more information about each consultation and:

- making submissions to the public consultations

- providing feedback to CMA for a CMA industry submission.

The TGA are holding an information session style online webinar on proposed changes to the Therapeutic Goods Advertising Code .

The webinar will be held next Wednesday 26 May 2021, 12pm-2pm (AEST).

The webinar will provide an overview of the key issues contained in the public consultation paper, including Q & A time throughout. The TGA have provided that the webinar will support stakeholders in considering the consultation paper.

Register for the webinar here.

Today's technical alert includes important information for members in relation to a recent safety review of titanium dioxide. In Australian therapeutic goods, titanium dioxide is used in listed and registered medicines. In listed medicines, when used as an excipient, titanium dioxide is approved for use only as a colour and only in medicines limited to oral and topical routes of administration. Today's alert includes:

 - Current information on EU activities

 - Effect this could have on TGA and FSANZ activities relating to medicines and foods containing the ingredient

 - Actions members should consider in relation to this information

 - History of the considerations since 2016, as provided by IADSA

Please read the full alert for more details.

Today's technical alert provides a reminder on important information for sponsors in relation to mandatory pharmacovigilance requirements and best practice TGA expectations. This technical alert was originally sent to members in November 2020 with a member alert, as well as a public link that can be accessed by non-members, describing the mandatory requirements.

Included in both the public and member only alert is a reminder that notifying the TGA of a sponsor's pharmacovigilance contact person is a mandatory requirement under the Therapeutic goods Act 1989 -  please ensure that your company has an up-to-date pharmacovigilance contact person provided to the TGA and other mandatory requirements are met as outlined in this alert and on the TGA website.

The 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 TGA is seeking feedback on proposed changes to the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code). The consultation closes on 18 June 2021.

The consultation provides that the changes/improvements proposed by the TGA are intended to minimise unnecessary compliance costs while continuing to ensure that advertising does not contribute to any unsafe or improper use of advertised products.

Different mechanisms for improving the Code have been proposed; for some provisions, minor wording changes have been proposed as well as the addition of new definitions and notes to improve clarity; for others, feedback is sought on options for combining provisions and other more significant changes.

CMA will be examining the proposed changes in detail and we encourage members to read today’s technical alert for more information on the consultation, including a summary of proposed changes and how to respond.

Today's technical alert provides information for members on menthol and methyl salicylate containing medicines for dermal use, including details of the current consultation on RASML for menthol and methyl salicylate for registered and OTC complementary medicines, and information on requirements for Listed medicines. 

The TGA have provided advice that an ingredient name change will be required for products on the ARTG that use the ingredient name 'oligofructose' in the formulation, as this name has changed to 'fructooligosaccharides'. 

Please read today’s technical alert for more information about the name change, including details about the ARTG entry changes (no fees will apply) and expectations to update labels by 31 December 2022. There will be the option to apply for a free-of-charge Section 14 application to continue supply products with affected labels for 18 months.

This technical alert  contains information on the public consultations for amygdalin (including hydrocyanic acid), which may be relevant to herbal medicine businesses and others with an interest in history and Scheduling of amygdalin.

The TGA have announced the third TGA GMP forum on their website. Dates have been confirmed for Wednesday 12 May - Friday 14 May 2021. The Forum will be held as a virtual event due to the ongoing uncertainty as a result of the COVID-19 pandemic.

The free event will cover a range of informative topics within the Manufacturing Quality Branch's (MQB) GMP portfolio including information on changes in GMP oversight as a result of COVID-19 as well as technical GMP subjects and insights. 

Please read today's technical alert for a summary of the Forum program.