Life Sciences Insights

02 April 2007

Welcome to the first edition of Life Sciences Insights for 2007.

In this edition we will focus on significant regulatory developments including progress with ANZTPA, in particular, amendments relating to the draft advertising rule which looks set to widen requirements for therapeutic advertising approval. We cover all the latest news on the Therapeutic Products and Medicines Bill which, when passed, will implement ANZTPA and govern the regulation of therapeutic products both in Australia and New Zealand. We also look at the recent changes to the TGA's Good Manufacturing Practice Guidelines regarding clearance of overseas medicine manufacturers.

In our features section, we introduce you to the science team in our Perth office and consider a recent significant case from the English Court of Appeal, Piper v JRI Manufacturing Ltd. This decision underscores to Australian manufacturer

Update on ANZTPA - the Draft Advertising Rule

By Andrew Morrison, null null and Gabe Hau.

ANZTPA looks set to change and widen the requirements for therapeutic advertising approval say Andrew Morrison, Jodi Ainsworth and Gabe Hau.

Meet the Team

Meet the Perth Science team, Dr Michael Maxwell, Senior Associate, and Ben De Campo, Senior Analyst/Law Clerk.

Defences to liability for defective products: Is there an international standard?

By Colin Loveday and Zöe Kimberley.

Colin Loveday and Zoë Kimberley explain what evidence an Australian court may require when a defendant argues there was no defect at the time of supply.

Quick dose

In brief: Recent ANZTPA consultation paper on regulation of clinical trials; Proposed amendments to the Therapeutic Goods advertising code; Further news on the fall out from the TGN1412 trial in the UK

When does a product contain a pharmaceutical substance for the purposes of a patent extension?

By Nicholas Tyacke and Amanda Riethmuller.

Nicholas Tyacke and Amanda Riethmuller ask "when does an approved product 'contain' or 'consist of' the substance claimed in the patent that is the subject of the extension application?"

Pharmaceutical patent term extensions - Full Federal Court defines "first regulatory approval date"

By Nicholas Tyacke.

Nicholas Tyacke examines the recent Full Federal Court decision in Pfizer Corp v Commissioner of Patents.
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