ATMP/MDD overlap: UK flowchart gives pointers
This article was originally published in Clinica
Executive Summary
The consultation on the regulation Advanced Therapy Medicinal Products (ATMPs), just published by the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) contains a flowchart (see this issue, p 6), which attempts to explain to those manufacturers with products on the borderline between medical devices and ATMPs, the regulatory route which they should follow.