Regulatory Blog

The European Medicines Agency (EMA) has released a major draft guideline " Non-Inferiority and Equivalence Comparisons in Clinical Trials "  that updates how non-inferiority and equivalence comparisons should be designed, justified, and analysed in confirmatory clinical trials. This draft replaces two earlier documents: Guideline on the choice of the non-inferiority margin  (2005), and Points to consider on switching between superiority and non-inferiority  (2000). The new gu