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EudraVigilance Medicinal Product Dictionary requirements

The new regulation has caught many in the industry off guard and the European Medicines Agency has given companies just months to respond to this mandate, one of the most expansive regulatory reforms in decades

Data files - EudraVigilance Medicinal Product Dictionary (EVMPD)On July 1, 2011, the European Medicines Agency (EMA) issued a legal notice saying that the EU had passed into law a mandatory requirement that marketing authorisation-holders submit within a year EudraVigilance Medicinal Product Dictionary (EVMPD) data for every pharmaceutical product authorised in the EU.

Two months later, the agency published updated guidance that included the XML schema files and controlled vocabularies and companies are now able to submit Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) messages via the EudraVigilance Gateway.

At least in theory. The reality is that companies are far from ready to meet the EVMPD mandate and even the regulators are not entirely prepared. In the coming months, the EMA is set to publish version three of the detailed guidance, make available a test environment for submissions and, in February 2012, make available the EudraVigilance Web Tool and EudraVigilance Trader that will allow manufacturers to prepare and submit online. All the while, industry must be ready for the EVMPD mandate by July 2, 2012, for every single authorised pharmaceutical product in the EU.

What is the EVMPD?
The EVMPD is the EMA's central database stating which products are registered where. The legal notice was issued under pharmacovigilance legislation and further enshrines patient safety under the law, giving regulators the effectiveness to act should they deem that an organisation has transgressed. This includes inspection and even, potentially, the ultimate sanction of product withdrawal.

The format for submission of the information is the EudraVigilance Product Report Message (EVPRM), which was updated to cover more information and is now termed XEVPRM. This is an interim format until the International Organisation for Standardisation's Identification of Medicinal Product (IDMP) standards are implemented in 2015.

As anyone working in the regulatory environment in Europe knows, the EVMPD is not new. It was originally launched 10 years ago, in December 2001, as a voluntary pharmacovigilance code to manage the reporting and evaluation of suspected adverse drug reactions. The EMA had hoped more organisations would enact EVMPD, but it enjoyed very little industry uptake.

Addressing concerns
Since the mandating of the EVMPD was first mooted, there has been much disquiet across the industry and for good reason. The mandate requires new and additional work for companies at a time when those companies have fewer people and resources to manage it.

The EMA has attempted to answer questions and concerns through its website, at training courses and at an information day in September 2011, which quickly sold out and had a long waiting list of individuals eager to attend. Recognising the desperate need for information, the agency has committed to hold more information days in the months leading up to the July 2012 deadline.

Questions keep arriving at the agency, which has promised to publish answers and is also busy fielding questions individually. But given the short time frame from announcement to implementation, both regulators and industry are likely to be under intense pressure in the months ahead.

The size of the task really depends on the size of the company and the number of products it has on the market. For small companies with one or two products – particularly those with products new to market – it is a relatively simple matter. But it becomes an exponentially harder issue for companies with many products on the market, which may have been authorised over an extended time.

Meeting requirements
To understand what the EVMPD affects, it is important to know that EVMPD has various parts. There is the authorised products side and there is also the development products side or, in other words, products under investigation. It is the former – authorised products – that are affected by the July 2012 deadline, and that is where industry's focus and concern lie, or should lie, for the time being.

That is because it affects every authorised product in Europe. In theory, this is all information that lies somewhere in a company's databases. The difficulty involves locating and collating those data, particularly given that some information will be with affiliates. To date, there has been neither a good way nor a compelling reason for headquarters and affiliates to share the totality of product data across a company's portfolio. What it means is that few companies know definitively what is registered where, which, not surprisingly, presents a significant challenge when it comes to collating product data.

Duplicated efforts
Furthermore, companies must also gather structured substance information (SSI), including both active ingredients and the excipients. This adds hugely to the workload companies face, since despite the fact that much of the excipient information will be the same across the industry, the agency has no plans at this stage to publish that information. The upshot is that each company will have to identify the same information and will also have to identify the manufacturers and grades of the materials used.
One suggestion that the agency has made is that companies collaborate to share this information, perhaps through trade associations. Whatever way the industry chooses to address the demand for SSI, there is no doubt that the burden on its resources, particularly busy regulatory and scientific personnel, will be extraordinary.

Confusion

Given the size of the task, it is no surprise that companies that are paying attention are in a quandary as to how to proceed. Some have even suggested that they do not intend to implement the EVMPD by the required date and will wait until the IDMP standards have been implemented instead. This is a deeply risky strategy.

The fact of the matter is, the penalties that may be imposed are unknown and why would a company choose to flout the regulators when they hold so much power over product authorisation? For example, even if the regulators do not remove a product from the market – a response some companies say is unlikely – they could very well make life difficult for those that fail to be compliant and they could put barriers in the way when it comes to registering new products.

One suggestion that the agency has made is that companies collaborate to share this information

There is also a misguided belief among some firms that the EVMPD is about pharmacovigilance and is not a regulatory function. Nothing could be further from the truth. While three or four fields are pure pharmacovigilance and a couple are clinical, the vast majority of this mandate pertains to regulatory requirements.

Action points
Undoubtedly, this is going to be a headache for industry, but it is one that every company faces and must find a way to manage. To start with, companies need to understand what data needs to be provided and must work out which data they have in the company and which they do not. Then it is a question of determining where the data lies, the quality of what is available and how data that is not readily accessible can be obtained. Some data points will be relatively easy to extract, for example, from the summary of product characteristics, while others will require detailed investigation.

Companies also need to make certain strategic decisions about how they will input the data. The EMA is providing a free tool for data entry. However, once the information goes in to that system, it is trapped there. Given that the real work involves finding and collating the data, it makes sense for companies to use their own databases or databases provided via cloud-based services, which would then enable them to access their product data for commercial purposes.

With July 2012 just around the corner, there is no time to waste. Much though the industry would like the regulators to postpone this legislation – and they have asked as much – it is European law and it will be enforced.

Rethink processes
There is no instant, press-a-button solution to the problem facing industry. Each company must search out its data and must then find somewhere to put it in a structured way, because no regulatory management system will be EVMPD-compliant in time, which means developed, configured, validated and having had regulatory personnel trained on it, for the July 2 deadline.

Technological solution
Technology can certainly be a component of the solution. In fact, given that this is an era in which raw computing power, connectivity and hosting are ubiquitous and can be commodities, it behoves companies to use the opportunity to rethink how they manage their regulatory information. Instead of spending money on in-house information technology systems for managing the information, less labour- and cost-intensive solutions such as the cloud create an opportunity to reduce cost, allow global reach in to product information and have quick and easy access to standardised regulatory solutions. Handled thoughtfully, companies can turn what may now appear to be a regulatory burden into a business enabler with fewer complexities.

Burden
Right now, the EVMPD seems like an extraordinary burden to many companies, and there is no doubting that the work involved in collating the data is significant. It will be interesting to see how companies view this legislation in two or three years' time. After all, when the electronic Common Technical Document was introduced, there was widespread panic but today most companies in both Europe and the US are comfortable with the format. More than likely, the same will be true of the EVMPD. For the next six months, however, hard work will be required.


Adam Sherlock
The Author
Adam Sherlock
is director of CSC Life Sciences

17th January 2012

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