Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether she plans to return to 12 months average timescales for the licensing of generic and biosimilar medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken urgent action to deliver improvements to decision timescales in established medicines. The timely processing of marketing authorisation applications to ensure continued access to medicines for the United Kingdom public is of the highest importance. The MHRA are taking significant steps to assess applications for medicines approvals within statutory timeframes.

As an effective regulator, the MHRA are committed to the highest of standards of performance and delivering the right outcomes for patients and public health. The MHRA will always prioritise applications according to public health need.

The MHRA are working to reduce timelines by bringing in additional resources and to develop processes that will result in significantly improved response times while protecting patient safety. The MHRA have published information on a new process that came into effect from 1 March that will help to ensure a smoother and more rapid approvals process for applicants.

The measures MHRA are taking to improve regulatory assessment times are beginning to take effect and we are confident they will result in significant reductions to average timescales. The MHRA are publishing monthly updates providing applicants with transparent information on expected timescales which can be found at the following link:

https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines