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.

1. 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

2. 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

3. 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

4. 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

5. 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 Variations to Biologicals 4