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Workflow practices within the Drug Safety and Evaluation Branch

A report to the Therapeutic Goods Administration

12 July 2006

In 2005 the Therapeutic Goods Administration (TGA) engaged the services of mpconsulting to provide advice on the most appropriate means for improving workflow practices within the Drug Safety and Evaluation Branch (DSEB). A review was completed which examined the workflow practices of DSEB with a view to aligning them with best practice and international standards.

Consultations with affected stakeholders were undertaken in late 2005 in both New Zealand and Australia. New Zealand stakeholders were consulted since it is anticipated that improvements implemented as a result of this review will flow through into the development of business practices for the Australia New Zealand Therapeutic Products Authority (ANZTPA).

The final report of this review is now available. The report recommends changes to current practices including changes to the way that applications to register or vary registrations of prescription medicines are processed. The report also makes recommendations to enhance the transparency of TGA operations including the publication of previously unpublished information.

How to access a pdf document

Workflow practices within the Drug Safety and Evaluation Branch - A report to the Therapeutic Goods Administration (pdf,119kb)

Contents

  • Glossary of terms and acronyms used
  • Background
  • Executive summary
  • Chapter 1: Application Entry Process
  • Chapter 2: Additional information and data
  • Chapter 3: ADEC Process
  • Chapter 4: Transparency
  • Chapter 5: Implementation and additional issues
  • Attachment A: Written submissions (removed from web version of report)
  • Attachment B: Background information about the TGA processes
  • Attachment C: International practice