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