What is EVMPD? And xEVMPD?
EVMPD stands for EudraVigilance Medicinal Product Dictionary and EudraVigilance stands for European Union Drug Regulating Authorities Pharmacovigilance – basically it’s the European Medicine Agency’s pharmacovigilance system.
xEVMPD stands for Extended EudraVigilance Medicinal Product Dictionary – see below for details.
EudraVigilance launched 2001
EudraVigilance was launched by the EMA in December 2001. It’s a data processing management system for reporting and evaluating suspected adverse drug reactions (ADRs) during the development and post marketing authorisation approval of medicinal products for human use in the European Economic Area (EEA) (ie all the countries in the EU plus Norway, Iceland and Lichtenstein).
EudraVigilance’s original brief was to allow details of adverse reaction reports to be exchanged electronically between the EMA, national competent authorities and (where appropriate) marketing authorisation holders and clinical trial sponsors. It aims to make possible early detection of safety signals related to medicinal products for human use and facilitate continuous monitoring and evaluation of any potential safety issues, so that risks to patients can be detected, assessed and minimised. The full text of the European legislation that started this off (Regulation (EC) No. 726/2004) can be found here – it’s Article 57(2) that is particularly relevant.
EVMPD launched 2005
The Medicinal Product Dictionary has actually been in existence since 2005 and since then all MA Holders have been able to submit basic details of their products to the EMA, either electronically or by manually by entering their data into the EudraVigilance web portal, EVWEB. However it was not mandatory to do so, so consequently the EVMPD currently contains less than 25% of the estimated 528,000 products authorised for use in the EU, and the data that is there is likely to be out of date.
2010 amendments – more information now required, including documents – xEVMPD
The original legislation was amended in December 2010 by Regulation (EU) No. 1235/2010, which describes the pharmacovigilance required for medicinal products for human use. This decreed that the EMA shall set up a list of all medicinal products for human use authorised in the EU, and that marketing authorisation holders were required, by 2 July 2012 at the latest, to electronically submit to the EMA information on all medicinal products for human use authorised or registered in the EU using the format defined by the EMA, and keep it up to date thereafter.
Crucially, the amount of information required by the EMA was significantly more than requested by the original version. For example information about excipients and adjuvents and their concentrations within the finished product was required, as was a document containing the printed product information (usually the SmPC). There was also guidance suggesting that very detailed and technical substance information (SSI) was also required, but the industry pushed back strongly on this and this requirement was subsequently withdrawn.
The EMA rebranded the EVMPD to be called xEVMPD (eXtended Eudravigilance Medicinal Product Dictionary) to draw attention to the fact that it was a new version and requires a lot more information than the original. The final specification of the information required was finally published in March 2012 – less than 4 months before the deadline.
XEVMPD became mandatory for all MAHs from 2 July 2012
The 2010 legislation meant that submitting product data to the EVMPD was no longer voluntary, and it became mandatory from 2 July 2012. The onus was on marketing authorisation holders to provide details of all their authorised products, either electronically from other systems or by manually typing the information using the EVWEB web portal.
Given the very short timescales – the requirements were only finalised in March 2012 – a large number of organisations, including many large ones, opted to us EVWEB to enter the data. There wasn’t time to locate, purchase, implement and populate a proper database application for the purpose in just 4 months. Many organisations simply did not manage to submit all their information in time, and instead prioritised their submissions according to their pharmacovigilance profile.
Those organisations who had already implemented Samarind RMS were fine of course. Samarind RMS has supported EVMPD since 2005 and was first to market with full support for the new xEVMPD. Samarind’s Cloud-based ‘On Demand’ web application also proved to be extremely popular, especially with smaller organisations.
xEVMPD maintenance, new fields and resubmission
Following the 2 July deadline, in theory, MAHs had an obligation to keep the data up to date thereafter. However, the rules around what had to be updated, and when, were far from clear, and several EMA pilot QC exercises revealed that the quality of the data that had been entered was in many instances very poor. Furthermore many of the controlled vocabularies, in particular the list of substances, had been open to additions and updates from all organisations, and the EMA found that it contained many duplicates and errors. EMA decided to instruct MAHs to not submit any updates until it had resolved the situation.
After regular meetings with industry representatives, and having reviewed the functionality of the EVMPD with respect to EU pharmacovigilance needs, EMA published new guidance in January 2014 which set out the following.
- Five (5) new fields are required for all authorised products
- Any errors and omissions in the already-submitted data are to be corrected
- Once correct, the data is to be kept up to date within 30 days using the ‘Update’ process, rather than the more complex, previously-proposed ‘Variation’ process.
- All existing products are to be updated with the corrections and the new fields by the end of December 2014. The EMA’s systems were updated on 16 June to include the new information and associated business rules.
For a more detailed discussion about what MA Holders need to do to comply with the latest guidance, please see Miranda’s blog postings.
Samarind RMS fully supports the new EMA xEVMPD maintenance guidelines. The Windows version was released in June 2014 and the On Demand version in September 2014.
What next? ISO IDMP?
The simplified process for updating the EVMPD is to be in force until the new ISO IDMP system is in place. According to EU legislation, this is to be in place by mid 2016. The EMA is now working on its ISO IDMP Implementation Guide.