We are seeking views on proposed updates to the definition of Gene Therapy Medicinal Products under the Human Medicines Regulations 2012 to better reflect advances in science and manufacturing. Current definitions do not fully capture emerging technologies such as synthetic nucleic acids and genome editing. The proposed changes will support access to innovative medicines.
Link to consultation document, proposals and questions: Click here
Privacy page: https://www.surveys.mhra.gov.uk/gtmp/privacy
Consultation closes: 23:59:00, 22 June 2026
Additionally, if you choose to respond line-by-line to the consultation document, you may find the following useful. Responding line-by-line is not mandatory.
Your respondent ID: 2f61061f-9bde-4add-90eb-ddab219a6a73
Link to line-by-line response sheet: Click here