B16. Prescription Medicine Branch annual update

Tracks
Prescription & Non-prescription Medicines Regulation
Wednesday, June 4, 2025
2:45 PM - 3:45 PM
Pyrmont Theatre

Chair & Speakers

Andrew Pengilley
Medical Officer, Prescriptipon Medicines Authorisation Branch, Department of Health and Aged care
TGA, Prescription Medicine Authorisation Branch

Prescription Medicine Branch annual update

Abstract

PMAB Branch update: Update on key issues in PMAB over last 12 months, including an update on
the potential for Sponsors to produce a pre-drafted assessment aid to assist TGA with the evaluation process, initially for oncology submissions.

Biography

Agenda Item Image
Andrew Simpson
Assistant Secretary Prescription Medicines Authorisation Branch Department of Health and Aged Care
TGA, Prescription Medicine Authorisation Branch

Prescription Medicine Branch annual update

Abstract

PMAB Branch update: Update on key issues in PMAB over last 12 months, including an update on
the potential for Sponsors to produce a pre-drafted assessment aid to assist TGA with the evaluation process, initially for oncology submissions.

Biography

Andrew has been with the Department of Health since 2015. Andrew has an extensive background in health policy. Prior to joining the PMAB team, he worked on the Primary Care Reform Taskforce and before that worked on the Department’s COVID-19 primary care response with responsibility for introducing telehealth Medicare items. He has also led the Medicare Review Taskforce.
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