It is more than a year since the date passed for the mandatory submission of data for the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) on 2 July 2012. Less than 50% of products were submitted by that date, but perhaps 85% have now been submitted. The EMA has not initiated validation of the content, but pilot assessments suggest that significant quality issues exist with the data already submitted, sufficient to render them unfit for the business purposes intended. Maintenance processes have not yet been initiated and data are becoming outdated. Revised guidance is expected by the end of this year, so it is anticipated that 2014 will be a year of significant effort by all concerned to get the data into usable condition and to maintain them from then on. The EMA, industry and software vendors need to work collaboratively to achieve these goals.
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