As we start what looks like another very busy year in the Life Sciences sector, it is important to pay enough attention to an important regulatory issue that will start to play a big role in 2014. I am referring to the issue, of course, of the EVMPD, the European Medicines Agency’s EudraVigilance Medicinal Products Dictionary.
You will recall that every pharmaceutical company that markets products in Europe has to submit the details of those products to the EMA’s database. You may also recall that there were some real challenges for the sector in meeting the original deadline of 2nd July 2012, due to the extremely tight timescales and the ambiguities in what exactly was needed.
Well – here we are again. The EMA guidance on the maintenance of this information is now published, and although we’re still waiting for the data quality guidance to be made available too (due soon) there’s plenty to be working on in the meantime.
As expected, the EMA requires all MA holders to resubmit their product information between June and the end of 2014. And yes, it’s re-submission that’s required, because there are new mandatory fields involved and the quality of the data must be improved. So rather like last time, you have pretty tight timescales in which to gather and submit your medicinal product information.
The key question is whether you will use the same method as you used last time. Many organisations in our sector either outsourced the job or used the EMA’s free tool to input the required information. Will this work this time too?
When I talk to organisations that used the EMA tool, the idea of resubmitting all their data using EVWeb horrifies them. Part of the problem was that this was a very time-consuming and error prone way of entering the data. That’s a point borne out by the fact that the EMA has done an analysis of the quality of the data that got submitted, finding it very poor.
Specifically, EMA has carried out two ‘pilot’ QC exercises so far, on a total of 116 products – which is of course a tiny proportion of the 400,000-plus that have been submitted so far. Its auditors found an average error rate of 17% across all fields – with many well over 30%. In the worst case, a staggering 65% of entries were incorrect!
It also notes that “there is a tendency of a higher rate of errors by organisations with large product portfolios”. That’s quite a sobering warning if you have a lot of products – as the more data you have, the more difficult it is to manage manually/in spreadsheets. All in all, EMA sees the current set of data as “unreliable” – perhaps not surprisingly.
What you want to do is to look at a much more holistic way of dealing with this issue. For example, our solution is a complete RIM (Regulatory Information Management) tool that can help you avoid not just these issues, but multiple challenges that arise around gathering compliance-related data. We can also import all your existing XEVPRM data.
If you’re not familiar with a RIM approach, think of it as a really well structured database where you can put all of your product information – and which then become the single version of ‘the truth’ for all your regulatory information.
This might just be a little bit better than what I suspect (from talking to many teams) is the current reality: lots of paper and lots of uncoordinated spreadsheets all over the place, which by definition means you end up with many slightly different versions of ‘the truth’ and no-one knowing which is the right one.
Unless you really want to work with EVweb again…? Well, I thought not!
To sum up then, I strongly recommend you look at an RIM way of dealing with EVMPD. Let’s do it right this time – it will save us all a lot time and money.
For more information about regulatory issues, please click here