Search Results for Australia

Showing 1 – 25  of 69

TGA to Move Forward With Orphan Drug Revamp By Michael Mezher - Published 18 April 2017

Australia's pharmaceutical industry is "broadly supportive" of proposed changes to the country's orphan drug program, the Therapeutic Goods Administration (TGA) says.

Categories: News, Oceania, TGA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Orphan Drugs, Australia

Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016) By Nick Paul Taylor - Published 04 October 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Australia drug manufacturing inspections, China medical devices

Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016) By Zachary Brennan - Published 20 September 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, PMDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Thai FDA, Skynet, Australia expedited pathways, CFDA on generics

Australia Outlines Major Drug Label Changes By Zachary Brennan - Published 09 August 2016

Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find.

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Drugs, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Australia drug labels, drug label, drug labeling changes, dispensing label

Asia Regulatory Roundup: Serious Injuries Linked to Devices in China Almost Double (31 May 2016) By Nick Paul Taylor - Published 31 May 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Compliance, Crisis management, Drugs, Medical Devices, Research and development

Tags: drug manufacturing in Australia, Indian drug inspections, medical device injuries, Asia Regulatory Roundup

Asia Regulatory Roundup: India Considers Phasing Out Gelatin-Based Capsules (12 April 2016) By Nick Paul Taylor - Published 12 April 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: DCGI, Asia Regulatory Roundup, device clinical trials, flu vaccine in Australia

Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015) By Nick Paul Taylor - Published 20 October 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, India, Japan, Middle East, Oceania, CDSCO, PMDA, TGA, Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDSCO, DRAP, Pakistan, India, DCGI, marijuana, Australia

Industry Group Pitches Changes to Australia’s Regulatory System By Michael Mezher - Published 19 January 2015

Medicines Australia, a trade group representing members of Australia’s pharmaceutical industry, is proposing a series of reforms to Australia’s regulatory system in the hopes of increasing the speed at which the Therapeutic Goods Administration (TGA) approves new medicines.

Categories: News, Oceania, TGA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Australia, Medicines Australia

Oceania Regulator ANZTPA Shut Down by Australia and New Zealand By Alexander Gaffney, RAC - Published 20 November 2014

Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency (ANZTPA), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries.

Categories: News, Oceania, ANZTPA, Medsafe, TGA, Drugs, Medical Devices

Tags: ANZTPA, TGA, Medsafe, ANZTPA Cancelled, Australia, New Zealand

Australian Government Orders Review of Drug and Device Regulations By Louise Zornoza, RegLink News - Published 27 October 2014

The Australian government has announced that experts will review the Therapeutic Goods Administration’s (TGA) framework for the regulation of medicines and medical devices.

Categories: News, Oceania, TGA, Drugs, Medical Devices

Tags: TGA, Australia

Australia’s TGA Issues Amended Nonclinical Studies Guidance By Louise Zornoza, RegLink News - Published 17 September 2014

Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued an amended guidance on nonclinical studies for Module 4 of the Common Technical Document (CTD), which is an integral part of an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). 

Categories: News, Oceania, TGA, Preclinical

Tags: ARTG, TGA, Australia, Module 4, CTD

Australian Regulator TGA Undergoing Reorganization By Louise Zornoza, RegLink News - Published 12 September 2014

Australia’s Therapeutic Goods Administration (TGA) has announced (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a "smaller and more rational" government.

Categories: News, Oceania, TGA, Drugs

Tags: Reorganization, Australian Finance Ministry, Australia

Australian TGA Taking a More Discerning Approach to Notified Bodies By Stewart Eisenhart, Emergo Group - Published 21 August 2014

The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used these Notified Bodies for certification.

Categories: News, Oceania, TGA, Audit, Medical Devices, Submission and registration

Tags: Notified Body, BMJ, British Medical Journal, Conformity Assessment, Australia

Australian Regulators Lift Ban on HIV Self-Test Kits By Louise Zornoza, RegLink - Published 11 July 2014

Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. 

Categories: News, Oceania, TGA, In vitro diagnostics, Medical Devices

Tags: HIV, HIV Self-Test Kits, National HIV Strategy, Australia

EMA, TGA Launch New 'Collaboration' to Accelerate Access for Orphan Medicines By Alexander Gaffney, RAC - Published 07 April 2014

Categories: EMA, TGA

Tags: Assessment Report, rare disease, Latest News, orphan drug, australia, EU

TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants By Louise Zornoza, RegLink - Published 31 March 2014

Categories: Regulatory Update, TGA

Tags: Nasal Decongestants, Cough Medicines, OTC, australia

Australian Regulators Launch Electronic Submission System for Pharmaceuticals By Alexander Gaffney, RAC - Published 26 February 2014

Categories: TGA

Tags: Electronic Common Technical Document, eCTD, australia

Australia’s TGA Warns Joint Implant Companies about Reclassification Deadline By Louise Zornoza, RegLink - Published 20 February 2014

Categories: TGA

Tags: australia

As Oceanic Regulator ANZTPA Comes Online, Harmonization Efforts Yield Results By Alexander Gaffney, RAC - Published 12 February 2014

Categories: ANZTPA, Medsafe, TGA

Tags: Tylenol, New Zealand, harmonization, Latest News, australia

TGA Says Interim Assessment Evidence Acceptable for Joint Reclassification By Louise Zornoza, RegLink - Published 21 January 2014

Categories: TGA

Tags: australia

Australia, New Zealand Launch Next Phase of Regulatory Harmonization Effort By Louise Zornoza, RegLink - Published 14 November 2013

Categories: Regulatory Update, ANZTPA, Medsafe, TGA

Tags: Regulatory Harmonization, New Zealand, harmonization, australia

TGA Adopts Internationally-Recognized E2B Reporting System By Louise Zornoza, RegLink - Published 13 November 2013

Categories: TGA

Tags: Adverse Events, australia

TGA Agrees to Device Single Audit Pilot with Brazil, Canada and US By Louise Zornoza, RegLink - Published 22 October 2013

Categories: TGA

Tags: australia, medical device

Australia’s TGA Issues Device Software Guidance By Louise Zornoza, RegLink - Published 18 September 2013

Categories: TGA

Tags: australia, medical device

Australia’s TGA Releases 2013-2015 International Engagement Strategy By Louise Zornoza, RegLink - Published 01 August 2013

Categories: TGA

Tags: australia