§ Paul FlynnTo ask the Secretary of State for Health what powers the Medicines and Healthcare Products Regulatory Agency has to obtain data from clinical trials conducted outside the United Kingdom. [158525]
§ Ms Rosie WintertonThere is an obligation on companies making an application for a marketing authorisation to provide the Medicines and Healthcare products Regulatory Agency (MHRA) with all relevant information at the time of the application; this includes data from clinical trials conducted outside the United Kingdom.
For marketed drugs, the marketing authorisation holder's "qualified person", who is responsible for their pharmacovigilance system, has an obligation to inform the MHRA of any information relevant to the evaluation of the risks and benefits of the product, including post-authorisation studies conducted outside the UK. In addition, the holder must report serious suspected adverse reactions relating to the product which occur in the UK and serious unexpected suspected adverse drug reactions which occur in a country outside the European Union, and provide periodic safety update reports to the MHRA, which should include any relevant data from clinical trials outside the UK.
Sponsors of clinical trials conducted in the UK have an obligation to submit adverse drug reactions (ADRs) to the MHRA on an ongoing basis and to provide end of trial study results in a report. Under the Clinical Trials Directive, to be implemented in the UK as of 1 May 2004, sponsors of trials conducted in the UK will have an obligation to report serious unexpected suspected adverse drug reactions to the MHRA, even if those reactions occur at trial sites outside the UK. In addition, they will be required to provide an annual safety report, which must include all serious suspected adverse reactions occurring in the course of the trial.
The implementation of the Clinical Trials Directive into UK legislation will provide a statutory basis for inspections of clinical trials to ensure compliance with the requirements of good clinical practice. This will also include an opportunity for inspectors to visit sites outside the EU member states where necessary. A reciprocal arrangement exists within the EU.