Discussion paper: Workflow practices within the Drug Safety and Evaluation Branch (DSEB) of the TGA

Consultation

2 November 2005

This consultation closed on 20 January 2006.
Consultation outcome: TGA releases final report into the review of workflow practices within the Drug Safety and Evaluation Branch (DSEB)

Introduction
Consultations with stakeholders
Discussion paper

Introduction

The Drug Safety and Evaluation Branch (DSEB) recently engaged the services of mpconsulting to provide advice on the most appropriate means for improving workflow practices within the Drug Safety and Evaluation Branch.

Following an initial exploration of some of the issues, mpconsulting has prepared a Discussion Paper to provide a basis for further discussions with stakeholders. The Discussion Paper:

provides background information about the current workflow practices within the Drug Safety and Evaluation Branch;
provides summary information about similar processes in some comparable countries;
identifies some opportunities for streamlining current pre-market workflow processes to provide greater planning capacity for the TGA and better meet the needs of industry; and
explores opportunities to improve the transparency of decisions made by the TGA.

Copies of the Discussion Paper may be obtained below or a printed copy of the Discussion Paper may be requested by writing to:

In Australia:
The Assistant Secretary
Drug Safety and Evaluation Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

In New Zealand:
Donna Fong
Medsafe
PO Box 5013
Wellington

Initially, it is anticipated that the TGA will wish to implement any improvements that can be made to their current business processes as a result of this review, ahead of the commencement of the joint trans-Tasman regulatory scheme. The consultation paper has therefore been drafted to reference current Australian practice when describing the status quo and commenting on alternative approaches.

Because the feedback from this consultation will also flow through into the development of business practices for the joint agency, feedback is being sought from both New Zealand and Australian stakeholders.

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Consultations with stakeholders

The DSEB and Joint Agency Establishment Group (JAEG) are keen to consult widely with stakeholders in both Australia and New Zealand on this Discussion Paper and conducted face-to-face consultations with key stakeholders in Sydney on 24 November 2005, Melbourne on 28 November 2005 and Auckland on 28 November 2005.