DARWIN EU: The Go-To Place For Real World Data
An EU-wide network of real-world data sources will aim to become the dominant vehicle for delivering such evidence to the EMA and member countries, who have until now been using a wide range of different sources to access such data.
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A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers.
The proposed European Health Data Space is expected to boost innovation in preventing, diagnosing and treating disease and to support the long-term competitiveness of the EU’s medical sector. The pharmaceutical industry has broadly welcomed the move but wants to see certain safeguards and guarantees put in place.
A new EU regulation has come into effect, giving the European Medicines Agency wider powers to monitor, prevent and manage shortages of medicines and medical devices in public health emergencies. A number of steering groups and other bodies and networks are being set up to put the new systems into action.