PBS Process Improvements
Page last updated: 19 April 2024
The Department of Health and Aged Care (the Department) and Medicines Australia have been working since late 2017 to deliver on commitments to streamline medicines listing processes and cost recovery arrangements as set out under the Strategic Agreement (2017-22) (PDF 7MB) - (Word 183KB).
The Commonwealth and Medicines Australia entered into a new Strategic Agreement (2022-27) (PDF 2MB) - (Word 132KB) that is in place from 1 July 2022 to 30 June 2027 with a focus on continuous process improvements to facilitate earlier patient access to medicines. The Agreement is monitored by the Department and Medicines Australia via a Joint Oversight Committee and the Access to Medicine Working Group (AMWG).
Stage 1 and Stage 2 PBS Process Improvements
From 1 July 2019:
- Changes to pre-submission meetings providing additional guidance and support for complex submissions.
- Introduction of a compulsory intent to apply step for Major and Minor submissions.
- Introduction of four new transparent pathways following a positive PBAC recommendation.
From 1 January 2021:
- Changes to initial submission categories (including introduction of a single submission date).
- Introduction of resubmission pathways for submissions not recommended by the PBAC.
- Revised cost recovery arrangements to support implementation of Stage 2 process improvements.
- Other improvements, including expansion of the department’s Health Products Portal functionality.
Procedure Guidance and forms to support the process improvements.
The Cost Recovery Implementation Statement and Cost Recovery Administration Guidelines are available on the Cost Recovery web page.
The Medicine Status Website (MSW) provides consumers, clinicians and other interested parties a one-stop shop for information on a medicine’s progress through the PBS listing process. It has been designed collaboratively with consumers, industry and the wider public.
Resources
- Stage 1 and Stage 2 PBS Process Improvements metrics report 2022-23 (PDF 241KB) - (Word 28KB)
- Stage 1 and Stage 2 PBS Process Improvements metrics report 2021-22 (PDF 245KB) - (Word 25KB)
- Stage 1 PBS Process Improvements metrics report 2020-21 (PDF 183KB) - (Word 17KB)
- Stage 1 PBS Process Improvements metrics report 2019-20 (PDF 780KB) - (Word 31KB)
- Health Products Portal (HPP) Program
Contact Us
If you have any questions regarding the PBS Process Improvements, please contact the PBS Process Improvements Section via: PBSimprovements@health.gov.au.
