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EMA announces reduced compulsory subset of data for EVMPD

EMA staff met with industry representatives yesterday (30 January) and announced a significantly reduced subset of information to be required for the xEVMPD by 2nd July 2012.

The Agency will not ask for the following mandatory data elements for medicinal products by July 2012:

  • Additional Monitoring
  • Location of the Pharmacovigilance System Master File
  • Description of packaging information
  • Regulated documents (Condition of marketing authorisation, Labelling and Package Leaflet).

In addition the highly controversial Structured Substance Information (SSI) is now optional. In terms of documents, only the SmPC will be required.

The news has been greeted positively by the industry and software vendors alike, although there is still a lot of information missing and many questions outstanding. The absence of a test system is also causing vendors problems, although those that supported the original EVMPD back in 2005, like Samarind, remain confident that only minor adjustments will be required to their software once it becomes available.

The EMA’s data entry tool, on the other hand, is now promised for mid April 2012.

The EMA is now working on updating all its documentations and providing examples, missing controlled vocabularies and Q&As. It also has to revise its training programme and adjust its business processes accordingly. Once all that’s done it will then revise its roadmap to progress from July 2012 towards the ISO IDMP standards implementation in 2015.

If you would like help with collating your EVMPD data, or a demonstration of Samarind's regulatory management software with its integrated XEVMPD tool, please contact us today.

Click on the following link to view the information that the EMA presented - note that it's 'Option 3' that was agreed.

Published 31/01/2012
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