RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • Australia’s TGA Launches Database of Adverse Event Notifications

    Australia's Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with access to adverse event reports. The database, which will be updated monthly, includes reports from January 1971 up until three months prior to the date of access to allow the agency to investigate new reports.   The database currently contains around 251,000 reports...
  • Australia Tackles Compounding Concerns

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on how best to address concerns that the current regulatory framework for compounding medicines does not provide adequate assurance that they meet acceptable standards of quality and safety. The TGA notes that the expansion of pharmaceutical compound manufacturing in Australia reflects international trends, and that there are concerns locally and overseas regarding the complexity and scale of ...
  • Australia Proposes Guidance on Role of Authorized Person in Drug Manufacturing Process

    Australia's Therapeutic Goods Administration has opened a new consultation on proposed guidance regarding the individual (known as the Qualified or Authorised Person) that must certify that a drug has been manufactured according to the requirements of the marketing authorization and cGMPs.  The Australian system is different from the European system of batch release by a Qualified Person, which is why the current PIC/S Guide to Good Manufacturing Practice for Med...
  • Changes Coming to Australian Advertising Rules

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...
  • TGA Opens Consultation on Rolling Adoption’ of PIC/S GMP Changes

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on implementing a 'rolling adoption' of new good manufacturing practice (GMP) versions of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S), two international instruments designed to improve co-operation between regulatory authorities and the pharmaceutical industry. The proposal would automatically adopt the new PIC/S changes during a transition p...
  • TGA Opens Consultation on New-to-Market Communication Proposal

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation to seek views from interested parties on the value, feasibility, design and impacts of a proposed new-to-market risk communication scheme. A new-to-market risk communication scheme is intended to signal to people using therapeutic products that a particular product is new, or newly available for a particular use.  For example, in the EU, a small black triangle is placed next to the name ...
  • Australia Opens Consultation on Proposed IVD Amendments

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed amendments to the new regulatory framework for in vitro diagnostic devices (IVDs) that covers both commercially manufactured IVDs and in-house IVDs (those IVDs developed or modified by providers for use in their own laboratories). Under the new regulatory framework, IVDs are deemed to be medical devices and, unless exempt, must fully comply with the new regulatory requirements as ...
  • 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...