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Presentation: Update and variations to biologicals

TGA presentation: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session, Canberra

1 November 2016


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Tony Manderson, Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration
  • Presented at: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session, Canberra
  • Presentation date: 13 October 2016
  • Presentation summary: A summary of recent updates affecting the regulation of biologicals, including recommendations from the Review of Medicines and Medical Devices Regulation, and relevant public consultations.


Update and Variations to Biologicals

Tony Manderson
Principal Advisor, Biological Science, Scientific Evaluation Branch, TGA

Biotherapeutics Association of Australasia 2016 AGM TGA Workshop & Education Session

Slide 1 - Updates impacting on BAA members

  1. Consultation on Autologous Cell & Tissues
    • Closed 6 October 2016
    • Thank you for BAA submission
  2. MMDR Recommendations
  3. Consultation on Biovigilance and RMP responsibilities
    • As presented by Bronwen Harvey and Rebecca Newton
  4. Consultation on Variations to Biologicals
    • Consultation open until 11 Nov and feedback encouraged
    • Concerned about compliance

Slide 2 - MMDR recommendations

  • Public Consultation during Oct-Nov 2016
    • Criteria for comparable overseas regulators: prescription medicines expedited pathways criteria and designation process
  • Targeted Consultations
    • First tranche during Oct-Dec 2016
      • Priority review of prescription medicines
      • Risk-based variations to registered medicines
    • Second tranche from Feb 2017
      • Provisional approval of prescription medicines including pharmacovigilance requirements (also a public consultation)
      • Evaluation of new medicine applications via work-sharing
      • Use of overseas reports in prescription medicines applications

Slide 3 - Improved Patient-Specific Access to Unapproved Therapeutic Goods

  • Targeted and Public Consultation (Feb-Mar 2017)
    • Streamlined process for Authorised Prescriber Scheme applications
    • Criteria for unapproved products of acceptable risk to be notified to TGA via the SAS Cat B Scheme

Further reviews

  • Targeted and Public Consultations (Oct 2016 on)
    • Review of the Scheduling Policy Framework
    • Review of the regulation of 'low risk' products on the ARTG

Slide 4 - Advertising of Therapeutic Goods

  • Targeted and Public Consultation (Oct - Nov 2016)
    • Options for complaint handling on proposed changes to the advertising framework - particularly compliance and enforcement

Support for Small and Medium Enterprises (SMEs)

  • Targeted Consultation (Oct - Nov 2016)
    • An options paper to inform and establish the SME support service

Slide 5 - Cost Recovery

  • Targeted Consultation (Feb - Mar 2017)
    • Consultation on fees and charges for 2017-18 for new and existing regulatory activities

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