I have been following the progress of the EMA’s XEVMPD QC process and the developments around the dreaded ‘3rd Ack’ for months now, and I’ve had discussions with many people about the challenges this causes for MA Holders. The key issue is that as part of the QC process, the EMA contractors are actually changing any data that they decide is incorrect, without telling the owners of the data exactly what they have changed.
There are a number of problems with this:
- You might disagree with the changes that EMA are making. The most common area of disagreement seems to be indications, and there are several examples of the organisation’s PV department persuading EMA that their original entry was in fact correct, and getting it changed back.
- If your EVMPD submissions were generated by an internal database system – either a full-blown RIM system or an EVMPD tool – once they have made a change, your internal data is out of sync with theirs. You need to identify the change and make the associated update to your database, otherwise you will not be able to update anything else. However you do need to know what they changed in order to do this! This is the information that is proposed to be contained in the 3rd Acknowledgement, albeit in free text, not in any structured format.
- Even if you agree with the change, you and your colleagues need to know what it was so that you can learn from your mistakes. Otherwise the same errors will be made in future submissions.
EMA send reports of the changes that are being made to QPPVs, however these apparently contain general guidance only, not full details of exactly what has been changed. MA Holders are left with the prospect of having to manually check every piece of data in their internal systems against that in the EMA’s system, which one organisation has estimated to be a task of at around 82 days for just over 1,000 of their products.
The industry associations are currently gathering information and views from their members in preparation for the next Article 57 Implementation Group meeting – I’ve had input into this myself – and I am well aware of the frustrations and additional work this is causing.
Also, as software developers now focused firmly on IDMP, my colleagues and I have little interest in making further complex changes to our EVMPD module – it just seems a waste of time for everyone. However, we have a saying in the UK that ‘necessity is the mother of invention’ and that’s certainly been the case here; we’ve come up with something to help with this challenge.
Samarind is developing an ‘XEVPRM Comparison’ tool to assist MA Holders with exactly this problem Andrew describes below. It takes two sets of files as inputs; your in-house generated submission files and an extract of the EVMPD data as produced by the EMA’s EVMPD export tool. It reads in both sets of files, then compares the data, field-by-field, and writes it to a user-friendly spreadsheet report. This can then be reviewed, filtered, sorted and further analysed to establish the changes that have been made by EMA so that you can decide what to do about them.
Where changes are required to the source data these would still of course need to be made manually in your in-house system, but the tool will cut out the huge amount of manual checking that you would otherwise need to do to establish where the differences lie.
The tool is scheduled for release next Friday, 27th February 2015 – and we are making it available to all EEA MA Holders completely free of charge.
It will of course be interesting to see what happens about the 3rd Ack, but in the meantime if you’re concerned that EMA is changing your data without telling you and you want an easy way to see what they changed, please email [email protected] or use our enquiry form.