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EMA Is Exploring How Real-World Data Can Benefit Europe’s OTC Market, Says Agency Head Rasi

 
• By David Ridley

The European Medicines Agency is right now looking into how real-world data and evidence can be used to improve regulatory systems and extend access to OTC medicines within the European Union, the agency's executive director Guido Rasi told the recent AESGP Regulatory Conference in Amsterdam.

Real world data
Real-world data can be used to expand access to OTCs • Source: Shutterstock

“Real-world data” (RWD) and “real-world evidence” (RWE) are fast becoming buzzwords in the global consumer healthcare industry, often mentioned with excitement within discussions about the future of the global OTC market.

For firms, RWD generated through smartphone apps and wearables offers a cost-efficient way to supplement the expensive clinical evidence needed for prescription-to-OTC switches and new indications for existing products

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