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  • 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...
  • 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 ...