Adaptive pathways at work

Country

United Kingdom

For more than a year, the European Medicines Agency (EMA) has been meeting individually with a number of companies that are developing products for difficult-to-treat diseases to speed the path towards registration. The discussions are non-binding, which means that regulatory approval is not assured. But they give both sides a chance to discuss the requirements of a good clinical programme, including the sort of information that will eventually be needed to show effectiveness in clinical practice.