To ask the Secretary of State for Health and Social Care, what steps the (a) Government, and (b) UK Health Security Agency are taking to ensure the Coronavirus Test Devices Approval process is held to the same operational standards of (i) transparency and (ii) communication with applicant companies as internationally recognised regulatory processes.
Throughout the Coronavirus Test Devices Approval (CDTA) process applicants have access to dedicated communication, review and complaint channels. Following the desktop review, applicants receive a report detailing whether the application guidance has been followed and if the threshold performance for specific technology has been met. Approved tests are also published on a register on GOV.UK and if an application is unsuccessful, the applicant can request that the Department reconsiders its decision.
Officials work with applicants to support them through the process and online guidance is provided on how to apply for the CTDA and the information required at each stage. The guidance is regularly refined, in line with standard regulatory process in the United Kingdom and internationally. We will review the CTDA process at the end of 2022 and consider its efficiency and transparency, including lessons learned from international regulators.