strategic initiatives

RWE for Regulatory Decision Making

ISPE Statement on Real-World Evidence (RWE)

ISPE RWE-related Guidance Documents and Policy Statements


Relevant RWE Guidance documents from Health Authorities

North America

Food & Drug Administration (FDA)

  • Guidance: Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
  • Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  • Guidance: Use of Electronic Health Records in Clinical Investigations
  • Framework for FDA’s Real-World Evidence Program


  • Prescription Drug User Fee Amendments (PDUFA VI)


  • 21st Century Cures Act


Health Canada

  • Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle
  • RWE for Drugs Project
  • Overall R2D2 project


Canadian Agency for Drugs and Technologies in Health (CADTH)


United Kingdom


UK Medicines and Healthcare products Regulatory Agency

  • Guidance on GxP data integrity


UK National Institute for Health and Care Excellence (NICE)

  • Evidence standards framework for digital health technologies




European Medicines Agency (EMA)

  • post-authorisation



China National Medical Products Administration

Japan Pharmaceuticals and Medical Devices Agency

  • Office of Advanced Evaluation with Electronic Data