Are You Prepared For The New European Pharmacovigilance Guidelines?

By Miranda Pothiawala, director and head of software, Samarind RM S.

EVMPD (EudraVigilance Medicinal Product Dictionary) requirements have moved back up the agenda for pharma companies marketing products in Europe, now that new requirements on data maintenance have finally been published.

For the 30 to 40 percent of organizations still struggling with initial electronic submissions, the new demands will be a bitter pill to swallow. To sweeten the transition, companies should look for the additional efficiency benefits that are possible once they have their data management ailments under control.

Following much anticipation, in late January 2014 the European Medicines Agency (EMA) finally issued expected guidelines on how to update/maintain data submitted to the extended EudraVigilance Medicinal Product Dictionary (XEVMPD). This aims to catalog all human drug products marketed in EU countries. The requirements come under Article 57(2), the official EU legislation that brought about the requirement for the XEVMPD database.

Any life sciences company distributing products in Europe had a mandate to submit complete product information and documentation to this central electronic database by July 2012. But to give the agency a chance to absorb and organize all of this content, companies were asked not to submit updates to this initial information until new guidelines had been issued on the process and timescales for ongoing data maintenance. That guidance has now been published, putting pharma organizations under new pressure to respond and get their submitted information up to date.

The New Diagnosis
It had been expected that ALL changes to marketing authorizations would have to be made within as short a time frame as 15 days; however, according to the issued guidelines, the 15-day period will only apply to new marketing authorizations. Updates to existing submissions will have a 30-day window, but even that is hardly any time, given the sheer volume of product files that will be affected.

Those firms that had been diligent in submitting their original product information well ahead of time will be dismayed to learn that updates will be required across almost all content — because new data fields have now been introduced. For instance, the agency now requires that companies indicate the size of their operations, i.e., whether they are small, medium, or large organizations. They must also provide information about the legal basis of the marketing authorization for each submission — i.e., which act they are applying under. Then they must apply the right product code, from a consolidated and cleanedup list, to ensure it is correctly categorized as herbal, pharmaceutical, etc. Finally, an authorized pharmaceutical form covering the dosage of products must be included.

Making Up For Lost Time
The agency is proposing a transition phase, between June and December of this year, during which marketing authorization holders are expected to bring their product data up to date and improve the quality of the data they have already submitted. But, however prepared companies feel, this won’t be easy. As organizations prepare to respond to the new requirements, they will need to take stock of where they are today and how far they still have to go before they are able to meet the latest XEVMPD requirements reliably and as painlessly as possible.

A conservative estimate based on our regular contact with pharma companies suggests that 30 to 40 percent of affected organizations have yet to finish their original submissions, so they do not yet even have a complete data set registered with the XEVMPD. Worse still, many firms had shelved XEVMPD initiatives while the new guidelines were being confirmed, so they have made little progress during the last 18 months. Now that there is no longer an excuse for inertia, companies have a lot of catching up to do.

Coordination Challenges
Although much of the required content already exists in companies, it is widely dispersed and is often captured manually in spreadsheets. The EMA provided a free online data entry tool, EVWEB, to make the process easier, but its parameters are basic, and use of the tool has resulted in variable quality in the information that has been submitted. In other cases, any initial sense of urgency soon became diluted once the deadline came and went and organizations realized that there were no real consequences for noncompliance — in that no firm has so far been penalized for noncompliance.

But the EVMPD/XEVMPD initiative is a work in progress, and now that standards have been issued concerning the way data must be updated, the EMA is likely to come down more heavily on companies that do not get their data in order. At the very least, this could lead to reputation damage if high-profile brands are exposed as being tardy in their submission activity, especially given that the whole point of pharmacovigilance is to improve consumer safety.

Finding The Right Cure
The only safe way to achieve compliance is to have reliable, fit-for-purpose processes and systems in place, which are geared toward clean, easy, and stable data capture, management, and reporting. By doing so, companies not only improve their ability to meet their EVMPD obligations, they also stand to benefit from all sorts of additional internal efficiencies. For example, capturing information in a central location means there is a “single place of truth”: information only has to be entered once yet can be accessed readily by anyone who needs it (assuming they have the relevant authorizations) and repurposed in all sorts of different ways. Other operational improvements could include accelerated workflow, improvements to data quality and reporting, easier auditing, and broader information compliance. By smoothing administrative processes, the right software also could help companies get new products to market in better quality and more quickly.

Data Quality Concerns
One of the issues the EMA has been grappling with has been the poor data quality that companies have submitted to its central database to date. For a limited period, the agency encouraged pharma companies to input their own categories into the controlled vocabularies used in the medicinal product dictionary. This has led to overlapping fields and duplication of content.

As it has sought to clean up this data, the agency has had to consolidate some of these codes, which is one of the reasons companies now need to resubmit a lot of content.

Going forward, companies will need to ensure that the data they submit is cleaner and more accurate. This means removing duplication and manual entry in internal data capture and management processes.

With eCTD (electronic common technical document)-based electronic regulatory submissions, validation criteria and tools exist to provide assurance around data quality. It is likely that similar aids and tools will be made available in due course to help ensure clean, compliant data for EVMPD.

Restoring Data Health
Quality control is vital if the goal of increased patient safety is to be met, and any life sciences company that takes pride in its brand will want to pay close attention to what goes into these central records. Whether penalties are applied or not for inadequate attention to EVMPD submissions, the last thing companies want is to fail to deliver against public health and safety improvement targets. However, it is likely that the XEVMPD data will be used for establishing marketing authorization holders’ pharmacovigilance fees, a subject that is being hotly debated at present.

There is some good news, too. The update process is being simplified so that it is no longer necessary to track each variation that is made to a product license. But overall there isn’t a great deal to smile about as pharma companies’ administration workloads multiply.

The only way to lighten the load is to get help to streamline processes, alleviate repetitive practices, and drive up data quality. Whether submitting for the first time or resubmitting and updating information, companies need to be able to extract and send the right content readily — and be able to vouch for its quality.

Getting this right sooner rather than later will pay dividends though. Over time, the EMA’s requirements will only become more stringent. The next iteration of XEVMPD — ISO IDMP, likely to become mandatory in 2016 — will take pharmacovigilance reporting to the next level, introducing significantly more data requirements and additional controls over data quality, among other measures. It is expected to have broader geographical application, too, i.e., beyond Europe. So making the effort to achieve compliance now will provide an important building block for the future.