Recent Legal Developments and the Authority of the Australian Therapeutic Goods Administration

(2009) 16 JLM 764

6 Pages Posted: 17 Nov 2014 Last revised: 3 Nov 2018

See all articles by Esme Shirlow

Esme Shirlow

King's College London; ANU College of Law

Thomas Alured Faunce

Australian National University

Multiple version iconThere are 2 versions of this paper

Date Written: November 15, 2014

Abstract

Recent legal developments have highlighted the need for greater support from the Federal Government for the authority of the Therapeutic Goods Administration (TGA) to ensure, by pre-approval assessments and post-approval regulation, the safety of listed medicines in Australia. One of these developments concerns the impact of ongoing civil litigation in Australian courts led by Pan Pharmaceuticals stakeholders to recover compensation from the government for the losses they incurred following the TGA’s post-listing shut-down of that pharmaceutical manufacturing company in 2003. Another factor is the recently announced governmental policy to outsource to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) safety assessments of foreign drug manufacturers whose products will be used in Australia.

Keywords: Therapeutic Goods Administration; safety assessment; regulation

Suggested Citation

Shirlow, Esme and Faunce, Thomas Alured, Recent Legal Developments and the Authority of the Australian Therapeutic Goods Administration (November 15, 2014). (2009) 16 JLM 764. Available at SSRN: https://ssrn.com/abstract=2524993

Esme Shirlow (Contact Author)

King's College London ( email )

Strand
London, England WC2R 2LS
United Kingdom

HOME PAGE: http://au.linkedin.com/pub/esme-shirlow/95/b5/a58/

ANU College of Law ( email )

Canberra, Australian Capital Territory 0200
Australia

Thomas Alured Faunce

Australian National University ( email )

Canberra, Australian Capital Territory 0200
Australia
61 2 61253563 (Phone)

Register to save articles to
your library

Register

Paper statistics

Downloads
14
Abstract Views
284
PlumX Metrics