• RoundupsRoundups

    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
  • Regulatory NewsRegulatory News

    New Zealand to Overhaul Regulatory System, Will Rely on Other Regulators' Approval of 'Cutting Edge' Products

    The government of New Zealand is working to completely overhaul its regulatory system for healthcare products by drafting new legislation to replace the country's Medicines Act of 1981 . The major changes being proposed are intended to modernize New Zealand's regulatory system by making it more flexible and efficient, while filling in "significant gaps in coverage" for medical devices and cell and tissue therapies. The plan would also allow New Zealand to recognize the...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Prepares to Invest in State Drug Regulators (22 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Sets Terms for State Regulatory Investment Plan The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals. Ministry of Health officials ha...
  • 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...
  • 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...
  • 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...
  • 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 and New Zealand Implement Harmonized OTC Regulatory System

    Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe have announced that a new over-the-counter (OTC) drug process for the evaluation of new and changed OTC medicines will be implemented in each country as of 15 April 2013. Companies will have a one-year transition phase to become familiar with the new submission formats, during which time OTC products already marketed will remain on the market and sponsors of new OTC products will comply with ...
  • Australia, New Zealand Propose Parallel Drug and Device Monitoring System

    In the latest collaboration since Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe agreed in 2011 to proceed with a joint scheme for the regulation of therapeutic products, the two agencies have jointly opened a consultation on a proposed parallel process for an early warning system concerning the safety of medicines and medical devices. Each regulatory agency would identify drugs and devices with potential safety concerns through their exis...
  • Australian, New Zealand Regulators Lay Out Framework for New Regulatory Agency

    The governments of Australia and New Zealand have jointly released a new policy paper establishing the proposed framework for the planned future merger of their two healthcare product regulatory agencies-the Therapeutic Goods Administration (TGA) of Australia and New Zealand's Medsafe-into the Australia New Zealand Therapeutic Products Agency (ANZTPA). The paper, released 8 January 2013, is intended to be "the start of a conversation with stakeholders," regulators explai...
  • Merger of Australian, New Zealand Regulatory Agencies on Track, Officials Say

    The planned merger of the regulatory authorities of Australia and New Zealand continues according to plan, both agencies said in an announcement on 29 November 2012. Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (MedSafe) have been planning for more than a year to merge the two agencies into a regional regulatory authority named the Australia New Zealand Therapeutic Products Agency (ANZTPA). In a st...
  • Australia Clarifies Transitional Requirements for Biologicals

    In May 2011 Australia's Therapeutic Goods Administration (TGA) put in place a  Biologicals Regulatory Framework  to assess and regulate human tissue-based products.  Until then, those products were either not regulated, regulated as drugs or devices, or exempt from certain parts of the Therapeutic Goods Act . As part of the three year transition period, the TGA yesterday issued a  notice  to sponsors of biologicals that are currently supplied in...