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  • 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 Releases New Joint Replacement Reclassification Guidance

    Australia's Therapeutic Goods Administration (TGA) has posted new guidance reclassifying joint replacements such as hip, knee and shoulder replacement devices. Under the new guidance, applications to reclassify a joint replacement implant from Class IIb (medium-high risk medical devices) to Class III (high-risk medical devices) could require more than one application. A single Class IIb joint implant may have to be 'cloned' into multiple reclassification applications i...
  • 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...
  • TGA Clarifies Evidence Needed for Joint Replacement Reclassification

    Australia's Therapeutic Goods Administration (TGA) has issued guidance regarding the types of evidence that must be submitted by companies to meet the conformity assessment requirements for the reclassification of hip, knee and shoulder joint replacement implants. The products are being changed from Class IIb designations, typically used for moderate-risk devices with special controls, to a Class III designation, which is typically given to high-risk medical devices.&n...
  • 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...
  • TGA Implements International Device Inspection Program

    Australia's Therapeutic Goods Administration (TGA) is implementing the Medical Device Single Audit Program (MDSAP), which aims to strengthen existing international cooperation in the field of medical device evaluation. The MDSAP is an initiative of the Medical Device Single Audit Program Working Group (MDSAP) of the International Medical Device Regulators Forum (IMDRF), which is the successor group to the Global Harmonization Task Force (GHTF). In furtherance of MDSAP,...
  • High Risk Devices to be Excluded From EU Mutual Recognition Agreement

    High-risk medical devices will no longer be eligible for mutual recognition of conformity assessment with the European Union (EU) as of 1 January 2013, according to the amended Mutual Recognition Agreement (MRA) concluded between Australia and the EU. All Class III-high risk-medical devices are excluded from the MRA until the appropriate confidence building activities have been undertaken between the two parties. Also excluded from the amended MRA are certain medical ...
  • 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's TGA Formulates New Steps for Drug Labeling and Packaging Review

    Australia's Therapeutic Goods Administration (TGA) has reviewed the comments submitted on its  Medicines Labeling and Packaging Review Consultation Paper , released in May 2012, and has identified  six issues  from the submitted comments that require further discussion with stakeholders: The need for some differences in the labeling requirements for different classes of medicine (prescription, over-the-counter and complementary); Evidence - the need, in ...
  • TGA Calls for Biologics Applications in Advance of Deadline

    Australia's Therapeutic Goods Administration (TGA) is reminding all biologics manufacturers that, per a new regulatory framework for biological medicines, that they must re-register their products with the Australian Register of Therapeutic Goods (ARTG) by 31 May 2014 or risk sanctions. The framework is intended to better regulate human tissue and cell-based therapies by classifying biological products based on risk, the agency has said. Under a new "special transitio...
  • Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions

    Australia's Therapeutic Goods Administration (TGA) has released responses submitted to the agency regarding a draft guideline set to change the way the regulator oversees over-the-counter (OTC) medications. The guidance, Australian regulatory guidelines for OTC medicines (ARGOM) , was first published in 2003, and since then has only undergone two minor updates in early 2011. In early 2012, TGA released a major planned update to the ARGOM, including the way it plans to ...
  • Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

    Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the electronic Common Technical Document (eCTD), it announced on 9 October. The eCTD is an electronic, module-based regulatory application format developed and maintained by the International Conference on Harmonisation (ICH). The basic premise of the eCTD is to harmonize the layout a...