• 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...
  • Australia’s TGA Issues Biosimilar Guidance

    Australia's Therapeutic Goods Administration (TGA) has issued guidance on the evaluation of biosimilar products, which identifies the data necessary to support applications for the registration of biosimilars and clarifies the scientific and regulatory principles used by the TGA to evaluate applications.  TGA notes that although most biosimilars contain biotechnology-derived proteins as the active substance(s), the guidance also covers biosimilars consisting of v...
  • ANZTPA Launches Joint Adverse Event Notifications System

    The Australia New Zealand Therapeutic Products Agency (ANZTPA) has launched an adverse event reporting database, the Joint Adverse Event Notifications System (JAENS), that combines drug and device adverse event reports received by Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe). Reports come from a wide range of sources, including members of the public, general practitioners, nurses, other h...
  • Australia Launches Consultation on Protecting Trade Secrets, Confirming Clinical Data Protections

    Australia's Therapeutic Goods Administration (TGA) has become the latest global regulatory agency to look to better define what it considers to be commercially confidential information (CCI), launching a new consultation on 27 June 2013 that explains in extensive detail what such information is-and just as importantly, is not. Clinical Trials Data: It's Confidential The document, Draft TGA Approach to Disclosure of Commercially Confidential Information , may be mos...
  • Australia’s TGA Releases Principles of Good Consultation Practices

    Australia's Therapeutic Goods Administration (TGA) has issued its Consultation Principles governing how the agency conducts its public consultation process on regulatory issues, including fundamental changes to primary legislation and minor administrative changes to internal procedures.  According to the TGA, the Principles have been developed in order to: Improve transparency - encouraging participation in the regulatory system and to keep stakeholders informe...
  • Australia Proposing 12 Month Trial Period for OTC Monograph Process

    Australia's Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or Monograph application) route to market. N2 applications will involve significantly reduced requirements for data assessment and consequently shorter evaluation timelines. Instead of providing full supporting data with the application, sponsors will only need to confirm that...