The European medicines safety watchdog is reviewing existing national and international patient registries in an attempt to improve and standardise data collection.
The European Medicines Agency (EMA) wants specifically to identify the challenges drug manufacturers and regulators face in using existing registries to monitor the safety and efficacy of authorised medicines because of the different ways data are currently collected and presented.
It will look at the existing network of registries held by manufacturers, physician organisations, national agencies and others, and consider establishing new registries if it discovers a gap in provision.
A cross-committee EMA task force has been established to lead the initiative. The task force will produce a strategy that will be tested to see whether it meets the needs and expectations of regulators, drug companies and others. The pilot is expected to run for two years.
“The aim of the pilot phase is not to make decisions about the need for a registry or to accelerate the granting of a market authorisation but to test whether such a planned, collaborative approach is successful in facilitating robust data collection,” says the EMA.