Summary
The Medicines and Healthcare products Regulatory Agency (MHRA) is leading on proposed changes to how gene therapies are defined in UK-wide medicines legislation. The proposed amendments would make regulatory oversight more consistent by ensuring that all relevant products are captured within an established and well-understood framework.
Consultation description
The MHRA has been working with the Department of Health in Northern Ireland and with the other devolved governments in the development of this consultation document. The proposed amendments relate to updates to legislative definitions of a class of medicines called Gene Therapy Medicinal Products (GTMPs), to allow for advances in manufacturing and technologies.