1. Pink Sheet

Acceptability Of RWD Must Be Decided On Case-By-Case Basis, Says EU Expert

 
• By Vibha Sharma

The former head of the European Medicines Agency’s Data Analytics and Methods Task Force says sponsors should engage early with regulators to get feedback on the suitability of real-world data for a regulatory application. However, industry suggests developing a fitness-for-purpose framework with specific criteria to determine when RWD may be appropriate.

Capsule in mid-air on graphs and big data of the global diffusion of the new pharmaceutical drug.
Study objectives should focus on providing evidence for regulatory assessment • Source: Shutterstock

It is not possible for the European Medicines Agency to offer generic guidance on when it can accept real-world data (RWD), under what conditions or for which types of regulatory submissions.

“We cannot provide this information because this is really [decided] on a case by case basis, based on the research question and the regulatory application,” said Xavier Kurz,

More from Europe

More from Geography