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Prescription medicines business process reform project

Introduction

In early 2009, the TGA commenced a significant program of business process reforms (BPR program) for the regulation of prescription medicines in Australia. The key elements of the BPR program were identified during an industry consultation workshop held on 17 December 2007 which brought together representative of the TGA, Medicines Australia, and the Department of Health and Ageing. These initiatives are part of the Australian Government's broader regulatory reform agenda.

There are three projects within the BPR program:

Streamlined submission process project

The streamlined submission process project will improve submission quality and provide predictable timeframes for the evaluation and registration of prescription medicines in Australia.

More about the streamlined submission process for prescription medicines

PI/CMI project

Since November 2009, the PI/CMI project has been providing through the TGA website, a single trusted source for product information (PI) and consumer medicine information (CMI). This will provide consumers and health professionals with enhanced access to prescription medicine information.

More about the PI/CMI project

AusPAR project

The AusPAR project is increasing the transparency of the prescription medicine regulatory process by publicly releasing (since December 2009), Australian Public Assessment Records (AusPAR) for new products of major variations to existing products.

AusPARs provide information about the TGA's evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine for registration in Australia.

More about the AusPAR project

BPR update newsletter

The Prescription medicine BPR update newsletter (BPR update) reports on progress in the BPR program. The first edition of BPR update was published in January 2011.

Each month, the BPR update reports on the progress of the streamlined submission process project. Each quarter, an update is provided on the PI/CMI project and the AusPAR project.

Consultation

Since April 2009, the Industry Working Group (IWG) has provided advice and assistance on the range of business process reforms. Under the terms of reference, members of the working group are not representatives of individual sponsors, but bring specific expertise to the working group.

More information