How are drugs licensed and approved in the UK? The European medical agency (EMA) is responsible for regulatory approval of new drugs within the European union (EU). As a result of the UK leaving the EU this is subject to change. The medicines and healthcare products regulatory agency (MHRA) is responsible for enforcing European drug approval regulations within the UK, making sure drugs are safe and effective. After a drug has been approved the national institute of clinical excellence (NICE) decides whether a drug should be made widely available on the NHS. Read the 'Access to medicines' presentation from the Action Duchenne International Conference.