INSIDE PHARMA

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INSIDE PHARMA
MHRA is scanning the horizon—and all it can see is gene therapies

MHRA is scanning the horizon—and all it can see is gene therapies

What's going on behind closed doors...

Hedley Rees's avatar
Hedley Rees
Aug 09, 2022
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INSIDE PHARMA
INSIDE PHARMA
MHRA is scanning the horizon—and all it can see is gene therapies
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My Curriculum Vitae

Are you beginning to join up the dots yet?

Yesterday, we exlored how UK Government, MHRA and other Government funded bodies are forming incestuous relationships to welcome in a new era of gene therapies. If you missed it, here it is again:

INSIDE PHARMA
MHRAs cavalier attitude toward patient safety carries on apace
MHRA updates its definition of reconstitution activities in 2022 In UK, MHRA has changed Regulations to facilitate mRNA technology (gene therapy), by changing its definition of reconstitution. In the 2022 update to MHRAs Regulatory Bible, the Orange Guide, changes have been introduced to the rules that apply to Advanced Therapy Medicinal Products only (AT…
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3 years ago · 9 likes · 6 comments · Hedley Rees

Horizon Scanning Case Study: Point of Care manufacture

Today, we dig into Horizon scanning at the MHRA, claiming it “leads to a proposed new framework to enable the supply and increase in the availability of innovative new medicinal products made at the point of care to patients.”

A new regulatory framework coming our way—that sounds interesting. Published 15th July 2022, it expalins what MHRA has been doing ‘scanning the horizon’. It goes back to what MHRA did in March 2021. stating:

“we held a stakeholder engagement event with over 50 attendees from across the healthcare sector to build on the learning points from the previous meetings. At this event we presented a high-level view of a proposed regulatory framework for POC manufacture, which is centre…

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