RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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...
  • TGA Says Interim Assessment Evidence Acceptable for Joint Reclassification

    Citing the difficulties faced by Australian companies trying to obtain examination evidence from European notified bodies, Australia's Therapeutic Goods Administration (TGA) announced on 17 January 2014 that it will accept summary technical reports as interim evidence to support applications for reclassification of partial hip, knee and shoulder implants from Class IIb to Class III.  The summary technical reports must demonstrate that the European not...
  • Australia, New Zealand Launch Next Phase of Regulatory Harmonization Effort

    Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe)  announced on 13 November 2013 the next stage of their joint efforts toward regulatory harmonization and the launch of a joint regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).. This new phase of joint work will cover the next two and a half years and targets 14 activities across the following six regul...
  • TGA Adopts Internationally-Recognized E2B Reporting System

    Australia's Therapeutic Goods Administration (TGA) has adopted a "streamlined" way for sponsors to submit  adverse event reports  for medicines and vaccines, aligning TGA's system with the European Union, the US, Japan and Canada. Sponsors are now able to submit adverse event reports by email ( e2b.reports@tga.gov.au ) using the international E2B standard, supported by the International Conference on Harmonization (ICH). Data supplied in this format can be ent...
  • TGA Agrees to Device Single Audit Pilot with Brazil, Canada and US

    Australia's Therapeutic Goods Administration (TGA) soon plans to launch the Medical Device Single Audit Program (MDSAP) pilot along with Brazil's Anvisa, Health Canada and the US Food and Drug Administration (FDA). The pilot, set to begin in January 2014, is designed to ensure recognition of a single audit of a medical device manufacturer by all of the participating countries. The pilot also includes the use of third party auditors, which allows greater coverage in audi...
  • Australia’s TGA Issues Device Software Guidance

    Australia's Therapeutic Goods Administration (TGA) issued guidance on 13 September 2013 on the regulatory arrangements pertaining to medical software and mobile medical apps by addressing questions frequently asked of the agency. Applications for inclusion of medical device software in the  Australian Register of Therapeutic Goods (ARTG)  are reviewed in accordance with the manufacturer's intended purpose and the manner in which the product is to be supplied...
  • Australia’s TGA Launches Online Adverse Event Reporting Portal for Medical Devices

    Online reporting of medical device adverse events through the Therapeutic Goods Administration's Incident Reporting and Investigation Scheme (IRIS) has been in place since November 2011, but until now follow-up and final reports still had to be submitted by email, fax or regular mail.  Now sponsors and manufacturers of medical devices can update submitted adverse event reports online through the Medical Device Incident Reporting (MDIR) system. TGA: Medical Device...
  • Australia’s TGA Releases 2013-2015 International Engagement Strategy

    Australia's Therapeutic Goods Administration has released an outline of its goals in the international arena for the next three years.  The International Engagement Strategy 2013-2015 links current Australian priorities for international engagement that are necessary to support effective therapeutic goods regulation with the TGA's day-to-day activities and sets clear goals for international engagement activities. Those activities include: Driving regulatory harm...