Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what testing requirements are in place in the approval process to identify the different impacts of medicines on men and women.

As part of the approval process for new drugs, the impact of sex, on men versus women, is assessed on pharmacokinetics, or exposure, pharmacodynamics, and overall efficacy and safety. The data is assessed in terms of whether any dose adjustments are warranted. Data in pregnant and breast-feeding women is also required where relevant.