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Re: ATLnsider post# 509241

Tuesday, 08/30/2022 2:18:17 AM

Tuesday, August 30, 2022 2:18:17 AM

Post# of 823753
I agree about FDA and Pazdur. But the UK’s approval will also flow through the Access Consortium, which will also be a positive and be more than just the UK. It provides access to markets with 145-150 million people.

Of course US approval will be far more meaningful and positive. But UK approval is not nothing.

“The Access Consortium aims to provide patients with timely access to high quality, safe and effective therapeutic products across the five countries. To accomplish this, the agencies work together using high standards of scientific rigour and integrity to reduce regulatory duplication.

According to the consortium, the MHRA will bring additional resources and expertise to the group and will officially begin collaborating as a full member on the 1 January 2021 with a period of shadowing prior to this date.”

https://www.europeanpharmaceuticalreview.com/news/130292/mhra-joins-international-regulatory-consortium/

It’s kind of like Project Orbis and there is some overlap but more countries too. Also former commonwealth countries tend to approve drugs approved in the UK.




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