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Volume 405: debated on Wednesday 21 May 2003

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To ask the Secretary of State for Health whether his Department has policies in place that encourage that anti-depressive drugs, which are used to treat depression in women, are tested on women during the drug qualification process. [114583]

The Medicines and Healthcare Products Regulatory Agency (MHRA), on behalf of the Licensing Authority, grants marketing authorisations for medicinal products provided that satisfactory quality, safety and efficacy data have been submitted for the medicinal product for use in the proposed indication and that the risk benefit is deemed favourable. Part of the assessment process involves ensuring that the target population to be treated has been adequately represented in the clinical trials submitted in support of the application.