english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2016 Recap > Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2016
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