Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent steps his Department has taken to approve the use of sepiapterin for people with phenylketonuria.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices and blood components for transfusion in the United Kingdom, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.

The MHRA has several licensing routes that are available to companies to support access of innovative medicines or medicines with unmet need to patients. Sepiapterin is currently not approved by the MHRA, however, it will assess any market authorisation applications for sepiapterin against the high standards of quality, safety and efficacy should an application be received.