Real-World Evidence regulatory guidance

This guidance provides further clarity around the definitions and use of Real-World Data (RWD) and Real-World-Evidence (RWE) in the over-the-counter (OTC) sector in the UK, based on the different OTC product lifecycle stages.

It also provides a simple guidance and identifies key common elements that need defining while in early phases of a real world project study design.

This guidance covers:

  • Generating RWE from RWD
  • Applications of RWD and RWE across the product lifestyle
  • Practical guidance on conducting Real-World studies

Real-World Evidence regulatory guidance

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