Update and Variations to Biologicals Tony Manderson Principal - PowerPoint PPT Presentation

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 13 October 2016

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 Update and Variations to Biologicals 1

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 Update and Variations to Biologicals 2

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 Update and Variations to Biologicals 3

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 Cost Recovery • Targeted Consultation (Feb - Mar 2017)  Consultation on fees and charges for 2017-18 for new and existing regulatory activities Update and V ariations to Biologicals 4