Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison.

ABSTRACT:

Background

The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines.

Methods and findings

We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national re

SUBMITTER: Zeitoun JD 

PROVIDER: S-EPMC4204813 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature