§ Mr. LansleyTo ask the Secretary of State for Health whether the full results of clinical trials submitted to the Medicines and Healthcare Products Regulatory Agency are required to be published. [163849]
§ Ms Rosie WintertonThe full results of clinical trials submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) are not required to be published. Sponsors of clinical trials conducted in the United Kingdom have an obligation to provide end of study data in a report. For marketed drugs, the marketing authorisation holder has an obligation to inform the MHRA of any information relevant to the evaluation of the risks and benefits of the product and provide periodic safety update reports to the MHRA. However, the MHRA has made information available about clinical trials in the specific circumstances where it has been in the public interest to do so.