European Medicines Agency (EMA) changes clinical trials rules!

Now, what's that all about? 🤔

Feb 07, 2023

∙ Paid

Hot on the heels of UKs MHRA changing regulations, applying only to advanced therapy medicinal products (ATMPs - includes gene therapies)—the European Medicines Agency is changing its rules for clinical trials. To recap on the UK change, see below:

INSIDE PHARMA

UK's gone bonkers over gene therapies—but they don't know what they don't know

MHRAs FOI response is deeply concerning You may remember the FOI that I submitted to MHRA last November. This is the FOI request. The FOI questioned a change that MHRA has made to its regulations allowing hospital pharmacies and other facilities carte blanch to ‘experiment’ with gene therapies. They achieved this by changing the age-long definition of ‘Reconstitution’ in the industry. This is what it was…

2 years ago · 20 likes · 7 comments · Hedley Rees

It ends as so:

“ATTC stands for “Advanced Therapy Treatment Centres”. Its website explains the mission:

“The ATTC project aims to develop robust systems for the routine delivery of ATMPs as a standard of care throughout the NHS in the United Kingdom.”

It then goes on to say:

“Over the last five years, new cell and gene therapies have been developed to treat some cancers and inherited diseases. These advanced therapies are different from existing treatments in two important ways: they are designed to restore normal function, sometimes offering cures where an unmet medical need exists and they require new ways of working by the NHS.”

We also learn: “The CGT Catapult is playing a central coordination role for the network and provide support to manufacturing, supply chain logistics, regulatory affairs, clinical trial capability, R&D support and upskilling via specialist training and development.”

We learn from the above that the changed regulations for Good Manufacturing and Distribution Practice (GMDP) allow hospital pharmacies, and similar establishments outside the regulatory safety umbrella, carte blanche to ‘experiment’ with gene and other advanced therapies.

What is the EU/EMA change to clinical trials all about?

This next change we are going to explore lends further credence to the UK being the global testbed for gene therapies, including mRNA injections, to be rolled out once implemented in the UK. The contention I’m making here is that this is the next step in the global rollout. Prepare for a shock…