MHRAs cavalier attitude toward patient safety carries on apace
Anything goes for gene therapies, apparently, and your government doesn't care!
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…