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Latest News | 2 May 2012

TGA Announces New Head of Agency

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Australia’s Therapeutic Goods Administration (TGA) announced it has appointed Dr. John Skerritt, previously the Deputy Secretary of the Department of Primary Industries in the Victorian government, as [Read More...]

Tags: Agency Australia Head National Manager Regulatory Skerritt TGA Therapeutic Goods Administration
Regulatory Update | 24 April 2012

Australia: Draft Guidance on Evidence to Support Indications for Low Risk Medicines

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Australia's Therapeutic Goods Administration (TGA) is seeking comment from interested parties on draft guidance Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and [Read More...]

Tags: Australia Claims drug Indication Label Labeling Pharmaceutical Safety TGA
Latest News | 23 April 2012

TGA Calls for Comments on Evidence Needed to Support Low-Risk Claims

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Australia’s Therapeutic Goods Administration (TGA) announced 23 April it is looking for comments on its draft guideline outlining the types of evidence needed to support indications made for low-risk [Read More...]

Tags: Australia Claims drug Indication Label Labeling Pharmaceutical Safety TGA
Latest News | 4 April 2012

Australian Adverse Event Database Hits Milestone

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Australia’s Therapeutic Goods Administration (TGA) announced its adverse reactions database hit a milestone 4 April, logging a quarter of a million valid reports.The database, which has been running [Read More...]

Tags: Adverse Events AERS Australia Online Reporting submission TGA
Latest News | 4 April 2012

Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

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An active pharmaceutical ingredient (API) inspection program involving many of the world’s premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the [Read More...]

Tags: API EDQM EMA FDA Global ICH Inspection Q7 TGA WHO
Latest News | 15 March 2012

Australia Launches Simplified Medical Device Adverse Event Reporting System

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Australia’s Therapeutic Goods Administration (TGA) released a new online system for reporting adverse events (AEs) attributable to medical devices this week. In a 14 March press release, TGA noted [Read More...]

Tags: Adverse Events AERS Australia Online Reporting submission TGA
Latest News | 5 March 2012

Australia’s Regulatory Body Takes Fire Over Medical Device Testing

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Australia’s Therapeutic Goods Administration (TGA) is taking fire from the Medical Journal of Australia (MJA) for a lack of medical device safety oversight, reports Fierce Medical Devices.MJA wrote 5 [Read More...]

Tags: Australia Clinical Data medical devices Medical Journal Australia MJA TGA
Latest News | 5 March 2012

Australia Proposes Ongoing API Inspection Cooperation

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Australia’s Therapeutic Goods Administration (TGA) said 2 March that it is working to establish “an ongoing collaboration in international inspection of [Active Pharmaceutical Ingredient (API)] [Read More...]

Tags: API Australia GMP Inspection Program TGA WHO
Latest News | 2 February 2012

Australia and New Zealand Agencies Announce Workflow Ahead of Planned Merger

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Australia’s Therapeutic Good Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority will be merged in to a single regulatory body in the next five years, according to a [Read More...]

Tags: Australia Combine MedSafe Merge New Zealand Regulatory Regulatory Body TGA Trans-Tasman
Latest News | 4 January 2012

TGA: PIP Implants in Australia not Likely to Rupture

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The Australian Therapeutic Goods Administration (TGA) today released statements indicating that, “there is no evidence of an increased rupture rate for PIP [Poly Implant Prothese] silicone gel breast [Read More...]

Tags: AFSSAPS Australia France Implants ISO 14607 PIP Poly Implant Prothese Rupture TGA