TGA Australia認証済みアカウント

New rules for custom-made medical devices come into effect 25 August 2021. If you are currently supplying a custom-made medical device see our website for more information -> https://www.tga.gov.au/regulatory-framework-personalised-medical-devices-frequently-asked-questions …pic.twitter.com/blqNROtkoD

We have made a Serious Scarcity Substitution Instrument to address an ongoing shortage of all strengths of PROGYNOVA estradiol valerate tablets and to assist patients in accessing their medicine from their pharmacist without delay. https://www.tga.gov.au/alert/substitution-instrument-address-shortage-progynova-estradiol-valerate-tablets-multiple-strengths …pic.twitter.com/tlsVQhQB7g

We’re seeking feedback on proposed changes to ingredients used in listed medicines (these are mostly vitamins, minerals and herbal supplements). Have your say using our online survey https://consultations.health.gov.au/medicines-regulation-division/low-neg-risk-2021-2022/ …pic.twitter.com/JJIdl16e2O

Vaccination against COVID-19 is the single most effective way to reduce severe illness and death from infection. Get reliable and up-to-date information about the safety of the vaccines in our #COVID19 vaccine weekly safety report: https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-12-08-2021 …pic.twitter.com/aczgOpywCs

Users of nicotine vaping products are encouraged to make an appointment with their GP to discuss their smoking cessation options, ahead of changes from 1 October 2021. Find out more: https://www.tga.gov.au/media-release/consumers-urged-see-their-gp-ahead-changes-nicotine-vaping-laws …pic.twitter.com/OA7yHaKdoW

If your software based medical device has been re-classified, you must notify the TGA before 25 August 2021. Watch this video for more information. Find out more on our website: https://www.tga.gov.au/resource/regulatory-changes-software-based-medical-devices …pic.twitter.com/l1oJF5ZDJk

Do you have unwanted medicines? The best way to discard unwanted medicines is to take them to your local pharmacist. Find out more: https://www.tga.gov.au/blogs/tga-topics/free-safe-and-confidential-way-get-rid-your-unwanted-medicines …pic.twitter.com/mNlc48UOLd

Medicine shortage update - tocilizumab (Actemra) medicines We have made a Serious Scarcity Substitution Instrument (SSSI) which allows pharmacists to substitute the specified Actemra products without prior approval from the prescriber. Read more: https://www.tga.gov.au/alert/tocilizumab-actemra-serious-scarcity-substitution-instrument …pic.twitter.com/ZzwbXwzAJ2

Have you registered for our third webinar on the Australian Unique Device Identification (UDI) system? #AusUDI Join us online on Tuesday 17 August from 11:30am-12:30pm for the discussion https://www.tga.gov.au/webinar-no3-challenges-and-considerations-journey-global-udi-system …pic.twitter.com/W8ymr4xk0H

The TGA has granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine—Spikevax (elasomeran). This is the fourth COVID-19 vaccine to receive regulatory approval in Australia. Find out more here: https://www.tga.gov.au/covid-19-vaccine-spikevax-elasomeran …pic.twitter.com/Hd14DYvFYu

We are investigating potential contamination of varenicline medicines with the nitrosamine impurity, N-nitrosovarenicline. Varenicline, marketed in Australia as Champix, is a prescription medicine that assists adults to stop smoking. Find out more: https://bit.ly/3lAsjGI pic.twitter.com/R6aSLnXEIb

Find out more about the regulatory changes for software based medical devices: https://www.tga.gov.au/resource/regulatory-changes-software-based-medical-devices …pic.twitter.com/cUPLXNaSgc

We're seeking #medical, scientific and consumer #health experts for our committees. Applications close on Tuesday 17 August 2021. Head to our website to find out more: https://www.tga.gov.au/vacancies-statutory-advisory-committees-and-australian-influenza-vaccine-committee …pic.twitter.com/nBqn4f1U0E

Share your views in our 2021 stakeholder survey. The survey takes around 10-15 minutes to complete and will remain open until 27 August 2020. https://healthau.au1.qualtrics.com/jfe/form/SV_00SlCdHLbrMxwjk …pic.twitter.com/Jq8Bo6Zr0j

Vaccination against COVID-19 is the single most effective way to reduce severe illness and death from infection. Get reliable and up-to-date information about the safety of the vaccines in our #COVID19 vaccine weekly safety report. Read more: https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-05-08-2021 …pic.twitter.com/sBcm1NrvzL

Medicine shortage update - tocilizumab (Actemra) medicines We have published a joint statement with the Australian Rheumatology Association and Arthritis Australia providing clinical guidelines to help health professionals manage this shortage https://www.tga.gov.au/alert/shortages-tocilizumab-actemra-medicines …pic.twitter.com/GLb6BRXY8Z

Part three of our #webinar series on the Australian Unique Device Identification (UDI) system is on Tuesday 17 August from 11:30am-12:30pm. Register online https://www.tga.gov.au/webinar-no3-challenges-and-considerations-journey-global-udi-system …pic.twitter.com/nHG04KHsBf

We have issued a Canberra-based dental practice with twenty infringement notices totalling $266,400 for alleged unlawful supply of dental implants and bone grafts that were not approved for use in Australia. Read more: https://www.tga.gov.au/media-release/canberra-dental-practice-fined-266400-alleged-unlawful-supply-dental-implants-and-bone-grafts …pic.twitter.com/E9npVVRtu0

Safety advisory - Black Ant King tablets Black Ant King tablets pose a serious risk to your health and should not be taken. Read more: https://www.tga.gov.au/alert/black-ant-king-tablets-1 …pic.twitter.com/RGkOscbA4q