EU's EMA Balances Medication Approvals with Health Care Data Management
title=Dealing with Global Pharmaceutical Standards} And similarly controlled terminology in medical information systems is there to control the quality of input. If a doctor puts in a reaction that is suspected to have been caused by a drug, the doctor will select the description of this adverse event from a drop-down list he or she has access to. We have in total now something like 4,000 organizations registered in one of our systems, and we have 8,000 individual users in that system. We have 21,000 users of our systems, of which 20,000 are external users.Historical developments have actually led to de facto technology standards.The European institution selected many years ago following an open call for tender Oracle as the database management system. As a result, we have Oracle as the database standard. There are a few exceptions, but mostly it's Oracle. This is one of these interesting discussions that is being had within the network, how to make sure these various national systems work with the European systems and with the European databases. What are the leading health care IT issues for the EMA? The most urgent and challenging one is how to go outside the EU today. Pharmaceutical really is global. It is necessary but not sufficient to have EU-wide standards. We need to have our standards aligned with worldwide standards. And we're working very closely with colleagues at the FDA and within ISO and HL7 to create worldwide technical standards-for example, to describe a medicinal product, to describe the minimal information and the way it's structured about an adverse drug reaction so that we can understand, for example, if the FDA sends us information about something that happened to a drug which is also sold in Europe. And they tell us about some real insufficiency or reaction so that a patient or a specialist here in Europe can actually see that information and understand it, and also use it in his or her data analysis. So that's by far the biggest challenge ... to align ourselves with worldwide standards. Changing a standard has a massive impact on the existing information systems. You have to change processing logic, and this causes big problems through Europe because people don't have the money to do that.