Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, by what date he expects the Medicines and Healthcare products Regulatory Agency to be able to process all D150 submissions within the 150 day timescale.

The statutory timelines for processing national applications is 210 days. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is working towards progressing priority applications and good quality submissions within 150 days. To achieve this, the MHRA is proactively engaging with the relevant Trade Associations on how best to improve the quality of marketing authorisation applications, including workshops to support companies. With the measures put in place, the MHRA anticipates that all priority and good quality dossiers that are compliant with legislative data requirements received from 1 January 2024 will be progressed within 150 days. Applications that do not meet these requirements will be progressed within the statutory 210 days.