The revamp of the TGA

by | Jul 19, 2015 | Analyisis, Blog, Business, Community Pharmacy, Regulation

The Therapeutic Goods Administration (TGA) are aiming to remove unnecessary duplication in assessing therapeutic goods in Australia where they have been approved elsewhere in the world.  New assessment protocols will allow changes to streamline the process and use global examples as a precedent.

The move is expected to streamline access in Australia to new medicines and devices after research showed that many Australian patients waited up to 15 months compared to Europe and the USA as many drug companies delayed bringing their business to Australia.

The move makes sense to the industry and with patient care at the heart of the decision it comes as a win for many Australian patients.

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Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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