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New data maintenance guidelines have sparked a flurry of activity in Europe.
New data maintenance guidelines have sparked a flurry of activity in Europe. Organizations are still grappling with electronic submissions, and the need to update data is intensifying the pressure. But there is an upside, says Miranda Pothiawala.
Earlier this year formal guidelines on how to maintain and update data submitted to the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) were published by the European Medicines Agency (EMA) - a development that leaves pharma companies with no choice but to get their internal data management processes in order if they haven’t already.
The aim of the XEVMPD is to catalogue all human drug products marketed in EU countries so that they are easier to track - in the interests of patient safety. The latest requirements covering the way this data is maintained come under Article 57, the official EU legislation that brought about the requirement for the central database.
Now that this guidance has been published, the pressure is on for pharma organizations to respond and get their submitted information up to date.
Those firms that had been diligent in submitting their original product information well ahead of time were dismayed to learn that updates will be required across almost ALL content - because new data fields have now been introduced.
The Agency is proposing a transition phase, between June and December of this year, during which marketing authorization holders are expected to bring their product data up to date and improve the quality of the data they have already submitted. For most companies, there will be a lot of work to do.
A conservative estimate based on Samarind’s sustained contact with pharma companies, suggests that 30–40% of affected organizations have yet to finish their original submissions.
The good news is that the process for submissions has been simplified so it is no longer necessary to track each variation that is made to a product licence. It is also likely that special aids and tools will be made available in due course to help ensure clean, compliant data for EVMPD.
Meanwhile the next iteration of XEVMPD, ISO IDMP (expected to become mandatory in 2016), will take pharmacovigilance reporting to the next level, introducing even greater data requirements and controls over data quality. ISO IDMP is expected to have broader geographical application too - ie beyond Europe.
So making the effort to achieve compliance now will stand companies in good stead as the global patient safety clampdown continues.