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Use Of Real-World Data Hindered By Different Regulator Requirements

 
• By Ian Schofield

Challenges to the use of real-world data and the importance of wider international regulatory collaborations were among topics addressed by the European industry body EFPIA in a survey of its member companies.

Extruded political Map of European Union with relief without United Kingdom after anticipated Brexit
Real-world data is being more widely used in the EU • Source: Alamy

Real-world data is increasingly being accepted by medicines agencies to support their regulatory decisions, whether on initial marketing authorizations or for post-marketing surveillance purposes. However, there are challenges to overcome, not least disparities between the requirements of the EU and US regulators, according to the European pharmaceutical industry federation, EFPIA.

These conclusions are contained in a report called Evidence Mix, which is based on a survey of EFPIA member companies in the context of the European Commission’s

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