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EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data

 
• By Vibha Sharma

While the International Council of Harmonisation is developing a harmonized approach to patient-focused drug development, the European Medicines Agency has heeded calls for “prompt guidance” to support the systematic inclusion of patient experience data in regulatory submissions.

Patient experience
Reinforcing Patient Relevance In Evidence Generation Is A Key Priority For The EU Medicines Network • Source: Shutterstock

The European Medicines Agency is making progress with developing its much-awaited reflection paper on the use of patient experience data (PED) in medicines development and regulatory decision-making following a workshop on this topic last year.

A draft version of the reflection paper is expected to be released for public consultation by the middle of this year. Also, there are plans to launch a survey in...

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