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

Journal of Law and Medicine, Vol. 16, pp. 764-769, 2009

6 Pages Posted: 23 May 2009 Last revised: 16 Jan 2020

See all articles by Esme Shirlow

Esme Shirlow

ANU College of Law

Thomas Alured Faunce

Australian National University

Date Written: February 23, 2009

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: Drug regulation, safety, FDA, EMEA, Pharmaceutical

Suggested Citation

Shirlow, Esme and Faunce, Thomas Alured, Recent Legal Developments and the Authority of the Australian Therapeutic Goods Administration (February 23, 2009). Journal of Law and Medicine, Vol. 16, pp. 764-769, 2009. Available at SSRN: https://ssrn.com/abstract=1409017

Esme Shirlow

ANU College of Law ( email )

Canberra, Australian Capital Territory 0200
Australia

Thomas Alured Faunce (Contact Author)

Australian National University ( email )

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

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