Drugs: Gender
The question
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of differences in approved medicines on (a) men and (b) women.
Answered by Karin Smyth
The Medicines and Healthcare products Regulatory Agency is responsible for approving medicines in the United Kingdom before they are made available to the wider public. This involves a rigorous assessment using data from clinical trials to assess safety and efficacy.
If data suggests that a medicine may have a different effect on men and women, this is considered within the assessment process. Every medicine is assessed on a case-by-case basis, as several factors may impact the performance of a specific product.
Post authorisation, where there is identified or potential differences between men and women in safety or effectiveness, this can be monitored in the risk management plan. The agency keeps the safety and effectiveness of all medicines under continual monitoring in all populations. Should any differences in outcomes between men and women be identified, the agency will take appropriate regulatory action.
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