The ISSCR recently delivered comments
on the draft Guideline on Registry-based Studies (EMA/502388/2020). Among other points, the letter stated support the crucial role of the European Medicines Agency (EMA) in overseeing the development of safe and effective new products and the draft Guideline on Registry-based Studies. The Society also encouraged EMA to clarify the appropriate uses for patient registries to prevent them from being abused by businesses seeking to prematurely commercialize unproven stem cell-based interventions.
Read the letter