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September 2020

Detoxologie fined $39,960 for alleged advertising breaches in relation to medical devices

25 September 2020

The TGA has issued three infringement notices totalling $39,960 to Sydney-based company Detoxologie Pty Ltd for alleged unlawful advertising
Manasmithra Vatika (Manasamitram Pills) Ayurvedic medicine

25 September 2020

Safety advisory - contains dangerous levels of lead and other heavy metals
Is my product a medical device?

25 September 2020

SME Assist has developed a new decision tool to help you determine if your product is a medical device.
Annual performance statistics report: July 2019 to June 2020

25 September 2020

The TGA 2019-20 Annual Performance Statistics Report has now been published
'Meeting Your Obligations' workshops

25 September 2020

SME Assist 'Meeting Your Obligation' workshop - expression of interest
Listed medicines at risk of containing safrole

25 September 2020

The TGA will soon commence compliance reviews of a selection of listed medicines at risk of containing safrole to ensure they meet regulator
Database of section 19A approvals to import and supply medicines to address medicine shortages

24 September 2020

Section 19A database has been updated to include new approvals
Declaration that certain sports supplements are therapeutic goods

24 September 2020

The TGA has made a section 7 declaration to declare that certain sports supplements are therapeutic goods
Disinfectants for use against COVID-19 in the ARTG for legal supply in Australia

23 September 2020

List of disinfectants included in the ARTG for use against COVID-19
AusPAR: Adalimumab

23 September 2020

Australian Public Assessment Report for Adalimumab
Access to nicotine-containing e-cigarettes

23 September 2020

Today the TGA announced an interim decision that, if made final, would clarify the regulation of e-cigarettes containing nicotine, and nicotine fluids for vaping
Public submissions on scheduling matters referred to the Joint ACMS-ACCS #25 meetings held in June 2020 - nicotine

23 September 2020

Public submissions on scheduling matters referred to the Joint ACMS-ACCS #25 meetings held in June 2020 - Nicotine
Nicotine scheduling

23 September 2020

Information about proposed changes to nicotine scheduling and how to make a submission
Consultation: Exploring options for the introduction of an Australian Unique Device Identification (UDI) System

23 September 2020

The TGA is seeking feedback on a second consultation paper on a UDI system for medical devices. Closing date: 18 November 2020
Consultation: Proposed enhancements to adverse event reporting for medical devices

23 September 2020

The TGA is seeking feedback on proposals that aim to enhance Australia’s medical device adverse event reporting system. Closing date: 18 November 2020
New Early Scientific Advice service to support medicine registrations

22 September 2020

TGA has launched the new Early Scientific Advice service, allowing applicants to request advice on biowaiver justifications
Early scientific advice

22 September 2020

Guidance on how to request Early Scientific Advice on a biowaiver justification
Updates to the Prescribing Medicines in Pregnancy database

18 September 2020

Sixteen medicines added, one medicine updated
Testing of medicinal cannabis products being supplied via SAS in Australia

18 September 2020

The TGA has released a report summarising the recent laboratory testing of medicinal cannabis products
Therapeutic goods advertising compliance: 2019-20 Annual Report

17 September 2020

Overview of therapeutic goods advertising complaints handling and compliance for 2019-20
Advertising of first aid creams containing bufexamac to cease in Australia

16 September 2020

Reminder to advertisers that first aid creams containing bufexamac cannot be advertised to Australian consumers from 18 September 2020
Vitrakvi

16 September 2020

TGA decision: Vitrakvi - larotrectinib sulfate is provisionally approved to treat patient with NTRK gene fusion metastatic solid tumours
AusPAR: Gilteritinib (as fumarate)

11 September 2020

New AusPAR for Xospata (gilteritinib as fumarate) for the treatment of relapsed or refractory acute myeloid leukaemia (AML)
Public submissions on scheduling matters referred to the ACMS #29, ACCS #27 and Joint ACMS-ACCS #24 meetings held in March 2020

11 September 2020

Public submissions on matters referred to the March 2020 scheduling meetings, and received during the interim consultation period
Publication of notified medicine shortages: Updated protocol

11 September 2020

From 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
AusPAR: Tafamidis and Tafamidis meglumine

10 September 2020

New AusPAR for Vyndamax (tafamidis) and Vyndaqel (tafamidis meglumine) for the treatment of transthyretin amyloid cardiomyopathy
AusPAR: Ranibizumab (rbe)

10 September 2020

New AusPAR for Lucentis (ranibizumab) for the treatment of retinopathy of prematurity (ROP)
Summary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia

9 September 2020

Summary and outcomes of recent consultation on IVD self-tests
Flucelvax Quad

9 September 2020

TGA decision: Flucelvax Quad (quadrivalent influenza vaccine, surface antigen, inactivated) is approved for influenza vaccination
Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS and Joint ACMS-ACCS meetings, June 2020

9 September 2020

Interim decisions and invitation for further comment. Closing date: 13 October 2020
Bufexamac

8 September 2020

Safety advisory - risk of serious skin reactions
Court proceedings commenced against HEALTHHUB247 and its director for alleged illegal activity relating to performance enhancing drugs

7 September 2020

Criminal court proceedings have been initiated in response to alleged breaches of the Therapeutic Goods Act 1989 by Brisbane-based company HEALTHHUB247 PTY LTD and its director
Information for medicine advertisers: Additional allergen warnings effective 1 September 2020

7 September 2020

Additional mandatory health warnings for medicines containing specific allergens are required in certain advertising from 1 September 2020
Shortage of olmesartan and prazosin tablets

4 September 2020

The TGA has issued Serious Shortage Substitution Notices for medicines containing olmesartan or prazosin as the sole active ingredient
Conference participation by the TGA

4 September 2020

The TGA is participating in these events and conferences
Therapeutic Goods Advertising Consultative Committee, 27 August 2020

4 September 2020

A meeting of the TGACC was held on 27 August 2020. A communique has been published.
AusPAR: Alpelisib

3 September 2020

New AusPAR for Piqray (alpelisib), in combination with fulvestrant, for the treatment of advanced or metastatic breast cancer
TGA initiates court proceedings against Oxymed Australia and director Malcolm Hooper for alleged unlawful advertising

3 September 2020

TGA initiates court proceedings for alleged unlawful advertising of hyperbaric oxygen therapy chambers
AusPAR: Tocilizumab (rch)

3 September 2020

New AusPAR for Actemra (tocilizumab) for the treatment of systemic juvenile idiopathic arthritis
Prescription medicines: registration of new generic medicines and biosimilar medicines

2 September 2020

7 medicine registrations added
Inclusions of new biologicals

2 September 2020

1 medicine registration added
Prescription medicines: registration of new chemical entities in Australia

2 September 2020

2 medicine registrations added
AusPAR: Insulin aspart (rys)

2 September 2020

New AusPAR for Fiasp, Fiasp Penfill, Fiasp FlexTouch (insulin aspart rys) for the treatment of diabetes mellitus
Markson Sparks fined $26,640 for alleged unlawful advertising of a medical device in relation to COVID-19

1 September 2020

The TGA has issued two infringement notices totalling $26,640 to Sydney-based company Markson Sparks for the alleged unlawful advertising of a medical device in relation to COVID-19

Last month's news & updates

URL:https://www.tga.gov.au/node/3394

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