english.prescrire.org > Topics > Advancing healthcare policy > Transparent, independent health authorities > Actions vis-à-vis regulatory agencies > Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)

Advancing healthcare policy

Transparent, independent health authorities

Transparent, independent health authorities: Actions vis-à-vis regulatory agencies
Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, market authorisation (October 2016)


Paris, 31 October 2016

Summary

The European Medicines Agency (EMA) has released a concept paper for public consultation on the revision of its guideline on the clinical evaluation required to apply for European marketing authorisation for antidiabetic drugs. In its response to this consultation, Prescrire reminds the EMA of the importance of evaluating the efficacy of antidiabetics using clinical endpoints useful to patients, and of evaluating their risks properly, in particular their cardiovascular risks, before authorisation rather than afterwards.

> Click here to download Prescrire's response to the consultation (pdf, 243 Ko)
 

©Prescrire October 2016