NHS: Drugs
The question
To ask the Secretary of State for Health and Social Care, whether his Department is taking steps to decrease the amount of time it takes for a repurposed medicine to be granted an MHRA licence.
Answered by Karin Smyth
The Medicines and products Regulatory Agency (MHRA) reviews the efficacy, safety and quality of a repurposed medicine in a similar way to other medicinal applications.
This review is part of the activities which MHRA contributes to under the Medicines Repurposing Programme. Once sufficient evidence is available, MHRA will consider the applications within the statutory timelines which can be expedited if company dossiers contain all required information. Timelines for assessment vary and depend on the nature of the application.
MHRA continuously reviews processes for the assessment of applications to determine whether any efficiencies and improved timelines are feasible.
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