The Learning Portal will be under maintenance Friday, 28 January from 10PM to 12AM. Portal functionality may be unavailable intermittently during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    Industry Group Pitches Changes to Australia’s Regulatory System

    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. Independent Review On 24 October 2014 the Australian government announced it would conduct an “independent review of the regulation of medicines and medical devices." The goal of the review will be...
  • Regulatory NewsRegulatory News

    Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

    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. Background The ANZTPA has been under development since at least 2011, and had reached several notable milestones since 2012. In September 2012, it put out a call to  harmonize over-the-counter drug regulations , and  co...
  • Regulatory NewsRegulatory News

    Australian Government Orders Review of Drug and Device Regulations

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Australian government has announced that experts will review the Therapeutic Goods Administration’s (TGA) framework for the regulation of medicines and medical devices. According to a 24 October 2014 announcement by Health Minister Peter Dutton and Assistant Minist...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. 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...
  • Regulatory NewsRegulatory News

    Australian Regulator TGA Undergoing Reorganization

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. 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. The D...
  • Regulatory NewsRegulatory News

    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. 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 the...
  • Regulatory NewsRegulatory News

    Australian Regulators Lift Ban on HIV Self-Test Kits

    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. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...
  • EMA, TGA Launch New 'Collaboration' to Accelerate Access for Orphan Medicines

    EU and Australian regulators have announced that they will begin sharing information about orphan medicines in an attempt to accelerate approval for new drugs intended for rare diseases. Background Orphan medicines are those intended for diseases or conditions which affect a small number of individuals-so-called "rare diseases"-and are thus less likely to have a ready market to incentivize investment in new therapies. The definition of "rare disease" differs throughout...
  • TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants

    Australia's Therapeutic Goods Administration (TGA) has released for comment proposed new warnings on the label of some OTC cough medicines intended for oral use by children. The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow recommendations made by TGA in 2012 to include warnings on products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, phol...
  • Australian Regulators Launch Electronic Submission System for Pharmaceuticals

    Australian regulators with its Therapeutic Goods Administration (TGA) have announced that they will soon adopt an electronic system capable of receiving drug applications without the use of paper. Background TGA first announced its intent to move forward with the transition in October 2013. At present, TGA receives all of its submissions in paper format, which is expensive for industry to create and regulators to store. New drug applications can be tens, and often hun...
  • Australia’s TGA Warns Joint Implant Companies about Reclassification Deadline

    Australia's Therapeutic Goods Administration (TGA) has issued a warning to hip, knee and shoulder implant companies that they will no longer be able to market their products later this year unless they submit reclassification applications for their devices. Joint implant devices are being reclassified from Class IIb (medium risk devices) to Class III (high risk devices) as of 1 July 2014, and the TGA gave companies a two-year grace period to file reclassification appl...
  • As Oceanic Regulator ANZTPA Comes Online, Harmonization Efforts Yield Results

    The regulatory systems of Australia and New Zealand have been slowly merging over the last few years, with the stated end goal of being able to provide better regulatory services at a lower cost to the taxpayers of each respective country. The Australia New Zealand Therapeutic Products Agency (ANZTPA), as the merged agencies will be called, has slowly been making note of its milestones over the last few years as it builds its regulatory capacities up and out. In Septe...