Therapeutic Goods Administration (TGA) | Australian Government Department of Health

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Pre-submission Pilot Annoucement

We are pleased to announce the future of the Pre-submission Pilot of the prescription medicines registration process

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Expert review of medicines and medical device regulation

Australian Government Response to the Review of Medicines and Medical Devices Regulation

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Statutory advisory committee vacancies

Committee Members and Expert Advisors are being sought from a range of fields

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Clearer labels for medicines in Australia

Medicine labels are changing to make important information about your medicine easier to find.

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Industry - Check your contact details are current

Login to TGA Business Services and review under ‘View my organisation’

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Consumers

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Health professionals

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Do you prescribe or use therapeutic goods as a professional?

Industry

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Safety information

Metformin extended release tablets

28 September 2016

Update – medicine shortages change in status

LFIT Anatomic CoCr V40 femoral heads (used in hip replacements)

27 September 2016

Hazard alert – risk of adverse events due to potential taper lock failures

Breast implants: Update on TGA monitoring of anaplastic large cell lymphoma

27 September 2016

Safety advisory

Metagenics NasoClear

27 September 2016

Recall - potential bacterial contamination

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News

Consultations on adoption of European Union guidelines in Australia

28 September 2016

Consultation: EU guidelines proposed for adoption. Closing date: 9 November 2016

Performance statistics report: July 2015 to June 2016

28 September 2016

The performance statistics report for July 2015 to June 2016 is now available

Prescription medicines: registration of new chemical entities in Australia

27 September 2016

Added registered new chemical entities for Idelvion (albutrepenonacog alfa), Zinbryta (daclizumab) and Empliciti (elotuzumab)

Prescription medicines: new or extended uses, or new combinations of registered medicines

27 September 2016

Added Adcetris (brentuximab vedotin (rch))

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