Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that (a) clinical trials and (b) market authorisations from the UK’s Medicines and Healthcare products Regulatory Agency comply with European Medicines Agency standards in order to obtain approval for use in the EU market.

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken pragmatic steps to ensure that the United Kingdom continues to have innovative and cost-effective treatments that benefit patients and boost growth in the life sciences sector. This includes limiting any additional cost or burden on industry by considering applications for marketing authorisations in the UK on the basis of information consistent with that being submitted to the European Medicines Agency (EMA).

As for clinical trials, the MHRA will continue to approve applications at a national level, working to international standards as they are now, using a UK data package whose requirements are consistent with those in the European Union. The UK will still have the ability to participate in multinational trials, as, data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU, and indeed globally. This ensures the UK remains an attractive location for trials to take place, with a view to getting medicinal products licensed in the UK and elsewhere.