current affairs

TGA guidance pages have changed. This page describes the changes to the way the TGA presents its guidance. Guidance documents are now all listed here. And on this page you can complete a survey giving the TGA your feedback about these changes.

Some relevant guidance updates:

* Understanding the legislative framework for listed medicines – updated 20 November, here

* Understanding listed medicines compliance reviews – updated 20 November – here

* Understanding the application requirements for an assessed listed medicine – updated 20 November, read it here

* CTD Module 1: Administrative information for assessed listed medicines – updated 20 November, here

* Completing the application form for an assessed listed medicine.- updated 19 November, is here

* ‘TGA assessed’ claim for sponsors of assessed listed medicines and registered complementary medicines. How to use the permitted symbols and wording on labels and advertising – updated 19 November – read about it here.

* Exporting medicines from Australia, including export-only medicines and medicines authorised for sale in Australia. updated 1 October – here

* Understanding personalised medical devices rules (including 3D-printed devices) – updated 1 November – here

* Regulatory Guidelines for Sunscreens. Primary sunscreens and some secondary sunscreens are regulated by the TGA as therapeutic products, and most secondary sunscreens are “excluded” and are regulated like cosmetics. Update guideline here.

NOTE we have a course Sunscreens– medicine or cosmetic? – view the agenda and book here.

Listed medicines compliance rating scheme commenced on 28 November 2018, an update was published on 19 November. A rating from A to F is allocated to each listed medicine reviewed. Read “What has changed and how does it work?”, the next steps, and a list of frequently asked questions and answers here.

Propolis and royal jelly: Changes have been made to the application form. Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. Updated 19 November. Source: TGA

Permitted indications for listed medicines. A comprehensive list of frequently asked questions and TGA answers can be found here. (important reading!)

Pharmacovigilance inspection programme – updated on 6 November – Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey. Medicine sponsors that do not complete this survey will be assigned the highest survey risk score. Read about this here.

Note: Our two-hour training course – Pharmacovigilance obligations – comes with a complete set of SOPs and forms that together provide a complete PV system. The course is presented by Mary Nteris, PhD, a specialist in this area who can also act as your “Qualified person responsible for pharmacovigilance in Australia (QPPVA)”. To see the course agenda and book, go here.

Consultations

Consultation on changes to 6 forms and processes, with closing dates ranging from 8th November 2024 up until 31st July 2029. See the full list here.

Compliance action

TGA and InstantScripts have reached a settlement after judicial proceedings. On 14 November 2023, the TGA issued 45 infringement notices to InstantScripts for the alleged unlawful advertising of prescription-only medicines on its website. On 15 March 2024, InstantScripts applied to the Federal Court for judicial review of the TGA’s decisions to issue the infringement notices. Source: TGA

Recalls

* Accu-Chek Spirit 3.15 ml cartridge system – leakage can occur at the luer connection, where the cartridge connects to an infusion set and insulin leakage might not be immediately detectable. Source: TGA

* The Omnipod DASH personal management system, works with a pod to dispense insulin. After the 3G network disconnection, the device is constantly trying to look for a network which depletes the battery much faster than normal operations. Source: TGA

Freedom of information request form, to request government documents from the TGA, is here

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.
* Story supplied by Michael Levin, Health Business Strategies:
BAPP SOP PRESENTATION AT SUPPLYSIDE WEST CONFIRMS BAPP WIN-WIN-WIN VALUE PROPOSITION: There is a substantial ROI associated with implementing the BAPP SOP. Learn from a major contract manufacturer and from a leading practitioner DS Brand of how adoption and implementation improved efficiencies, reduced rejections, cut testing costs, and help suppliers improve the quality of their ingredients. It was a positive learning experience for all involved. Read full article here.
* The 31st edition of the Botanical Adulterants Prevention Program’s newsletter has been published here.
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To access freely available botanical and technical resources from BAPP, click here 

USA news – medical devices
Contributed by Neil O’Flaherty, US medical device specialist at Amin Wasserman Gurnani:
U.S. Food and Drug Administration (FDA) has issued a new broad-reaching guidance document for clinical investigation sponsors, clinical investigators, institutional review boards (IRB), contract research organizations (CRO) and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations. Read more on FDA website here
New Zealand

On 7 November 2024, the Ministry of Health presented a public webinar on the planned Medical Products Bill. The Medical Products Bill is intended to replace the Medicines Act 1981. The video and transcript of the webinar have now been published on the Ministry of Health website here

Foods: