EU medicines regulator

08 Jul: Reinforcing the mandate for EU medicines regulator

(Source: European Parliament)

Better equip EU to manage future health crisesNew EU database to monitor and report medicine shortagesEnhanced coordination and transparency on clinical trials

On Thursday, Parliament adopted its position for negotiations with Council on extending the mandate of the European Medicines Agency and strengthening its role.

To enhance the agency’s powers in crisis preparedness, management for medicinal products and medical devices, MEPs call for the creation of an interoperable digital EU database aimed at detecting, predicting and preventing shortages of medicinal products. The new database would facilitate, on a permanent basis, access and exchange of information between the …

22 Jun: COVID-19 lessons learned: stronger role for EU medicines regulator

(Source: European Parliament)

Improved capacity for crisis preparedness and management of medical devices and products New EU database to monitor and report medicine shortages  Large-scale clinical trials and publication of marketing authorisation decisions 

Public health MEPs agree to change the European Medicines Agency’s mandate to reinforce its role and better equip the EU to manage future health crises.

The Committee on the Environment, Public Health and Food Safety (ENVI) adopted on Tuesday, with 68 votes in favour, 3 against and 8 abstentions, its negotiating position on the extension of the mandate of the European Medicines Agency (EMA). The position is scheduled …