Is UK MHRA playing with 'advanced therapy' fire, by allowing hospital pharmacies to complete final manufacture?
Yes, it's got a green light for go!
Advanced Therapy Treatment Centers (ATTCs)
In the UK, “Advanced Therapy Treatment Centres” have been established as part of an ongoing Government initiative. Its mission is explained in the website, as follows:
“Our 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.”
About Advanced Therapy Medicinal Products (ATMPs) in EU/UK
We know that within the EU/UK definition of Advanced Therapy Medicinal Products (ATMPs), there lay somatic-cell therapy, gene therapy and tissue engineered products. Additionally, there is…