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 Pharma eReport Blog

Date: 6th March 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA

Updated EVMPD guidance from EMA

Updated EVMPD guidance from EMA – so what next?

The EMA has just published the long-awaited update to its EVMPD guidance, covering specifications, controlled vocabularies and more.  As anticipated, and following the discussions at the 30th January cross-industry meeting, the EMA has elected to go with “Option 3” – a significantly reduced subset of information now required to meet the xEVMPD compliance deadline of 2nd July 2012.

In a revision of its previous requirements, the EMA has decided to reduce the number of mandatory data elements, in response to European pharmaceutical industry feedback regarding the practical challenges of compliance by July 2012.   The EMA has therefore decided not to request submission of the following data elements for medicinal products by the July 2012 deadline:

  • indication if the product is subject to additional monitoring
  • location of the pharmacovigilance system master file
  • description of packaging information
  • Structured Substance Information (SSI) data reporting

So, with a key element such as SSI data reporting now optional as opposed to mandatory, what does this mean for the industry’s implementation plans?

While it’s difficult to position the EVMPD mandate deadline as an “opportunity” for Marketing Authorisation Holders in the short term, there are competitive advantages to taking a logical, systematic approach to the data gathering and data logging right from the outset.

Firstly, let’s take a look at what the EMA is actually asking for in terms of data, both mandatory and optional. If you look at, for example, the data reporting requirements for “Authorised Product” and “Generic Product Name”, there are 6 separate fields to be filled.  As an initial task it’s laborious but, once it’s done, you can re-generate any product name instantly, plus a host of other information from the detail you’ve submitted.  So, from an administrative efficiency perspective, it absolutely makes sense to log as much detail as possible during the initial data gathering and data entry phase.

Moreover, much of the documentation held by pharmaceutical companies is in high-level format – so there may well be a sentence of product description used by MAHs that the EMA is requiring organisations to break down into individual components and constituent parts of a dataset. Taking another example, a Marketing Authorisation Holder may have the product description “Paracetamol in 500mg dosage and capsule format”.  For the purposes of EVMPD entry and sending an EVPRM, instead of it being a sentence, the EMA submission requirements will mean entering the data elements (“Paracetamol”, “500”, “mille”, “gram” and “capsule”) as discrete data fields.  While that may be time-consuming to do the first time, it’s very quick to reassemble the full product description from that baseline level of granularity. It would be very difficult, however, to generate the baseline data from the description without having gone through this process.

So, let’s look at this positively: once you’ve captured and centralised all this information, it will be possible to exploit the fact that the data is in this fine, granular form and to then generate all your documents from it. Once you have one central place for the data, you can eliminate unnecessary duplication and repetition; as soon one data element is changed, that change can be automatically and seamlessly propagated up through the documentation stream. 

There is an opportunity here: the opportunity to log a new level of detail that now only needs to exist in one place, rather than in several places, all written differently. With a centralised product information database, detailed product data can be produced differently from the same source data using a different syntax – all automatically generated and at the touch of a button.

This requirement for data granularity is undoubtedly the direction of travel for the EMA, and in which the coming ISO IMPD is set to continue.  So let’s embrace the opportunity – rather than trying to extract detail from a high-level document, let’s build our high-level documents from the detail.  It’s a logical approach that will more than repay the investment of time needed.

What do you think?  We’d be really interested in your thoughts.

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