Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency plans to consult representatives of (a) patient organisations and (b) the pharmaceutical industry on its plans for new regulatory recognition routes for medicines under the international recognition framework, starting on 1 January 2024.

Regarding the first part of the question on consultation with patient organisations, the Medicines and Healthcare products Regulatory Agency (MHRA) held a workshop on 3 November 2022 to obtain patient views on the MHRA’s proposals for a new International Recognition Framework. The MHRA intends to hold another patient workshop this Summer to discuss its proposals in further detail.

Regarding consultation with members of the pharmaceutical industry, the MHRA has held a number of workshops and focus groups with Trade Associations and their members to generate insight from industry subject matter experts. This has included a workshop on the MHRA’s early-stage prototype for the recognition framework to obtain feedback on practical implications. The MHRA will continue to closely engage with key stakeholder groups in the development of its International Recognition Framework.