EU’s EMA Balances Medication Approvals with Health Care Data Management

The equivalent of the U.S. Food and Drug Administration, the EMA (European Medicines Agency), based in London, is a public health agency in the European Union that approves drugs and provides guidelines for health care providers and pharmaceutical firms for a region spanning from the Arctic Circle to the Mediterranean Sea.

As the head of information and communications technology for the EMA, Hans-Georg Wagner oversees the IT operations of this regulatory agency. “The whole regulatory process of bringing drugs to market needs to be as sufficient as possible and as good-quality as possible so we can be sure that our scientific opinion stands,” Wagner said.

Wagner spoke with eWEEK about how the EMA deals with the challenges of handling 100-plus information systems, aligning with worldwide standards, and storing and analyzing 70 terabytes of medical data.

How does the EMA approach health care IT?

We have what we call basic IT-financial and budget systems, human resources, electronic document management, record management, print and file serving, access control systems, etc. So that’s standard stuff that anybody would need.

And going further out, there is a group of information systems directly related to the regulatory life cycle of medicinal products. So, for example, making sure that when a new application comes in, it’s actually registered and there is a formal reply provided. That the tracking process starts, that we can follow who is doing what.

So everything to do with the internal and external processes that will eventually lead to a scientific opinion. And of course everything to do with the monitoring of risk benefit profiles.

There is a family of information systems and standards and technical specifications called eSubmission, which is everything to do with using information technology to make it possible for applications and sponsors to submit their dossiers electronically in a single-defined format irrespective of the procedure to all the regulators.

For these things to work, we understood not immediately but a few years into the program that to achieve interoperability across Europe, you do have to have a common data model, which in Europe is called the reference data model.

And of course you need what is called controlled terminology.

If you try and book a flight with one of the cheap or not-so-cheap airlines online and want to enter the departure airport and the destination airport, you don’t have free text entry. You have to choose from a pick list. And that makes sure that you can’t enter an airport that doesn’t exist.