TGA grants provisional determination for COVID-19 vaccine

12 October 2020
australia_tga_big

Australia’s Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a provisional determination for UK drug major to AstraZeneca (LSE: AZN) in relation to its COVID-19 vaccine, ChAd0x1-S [recombinant]/AZD1222.

Granting of a provisional determination means that the TGA has made a decision that AstraZeneca is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). AstraZeneca is deveoping the vaccine in cooperation with Oxford University.

Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology