Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent discussions his Department has had with the Medicines and Healthcare products Regulatory Agency on plans to streamline the approval process of UK-made covid-19 tests.

Approval of COVID-19 tests for private use falls under the Coronavirus Test Devices Approvals regulation (CTDA). The CTDA process is robust, only devices that meet the high regulatory standards are available to the British public. Medicines and Healthcare products Regulatory Agency were heavily involved from the start in setting these high-performance standards.

25% of approved devices are from United Kingdom manufacturers, however, it is important as a fair and neutral regulator of market access that all applicants are treated equally and the Government is working at speed to review applications for devices submitted via this process. We have increased the number of scientific advisors to meet clinical demand and speed up CTDA approvals. Discussions are ongoing about how to further align regulation to ensure it works best for industry and the public.