strategic initiatives

RWE for Regulatory Decision Making

ISPE Newly Ratified Statement on 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

https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

 

  • Prescription Drug User Fee Amendments (PDUFA VI)

https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-fiscal-years-2018-2022

 

  • 21st Century Cures Act

https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/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

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/optimizing-real-world-evidence-regulatory-decisions.html

 

Canadian Agency for Drugs and Technologies in Health (CADTH)

https://www.cadth.ca/use-real-world-evidence-single-drug-assessments-environmental-scan

 

United Kingdom

 

UK Medicines and Healthcare products Regulatory Agency

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

  • Guidance on GxP data integrity

https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity

 

UK National Institute for Health and Care Excellence (NICE)

  • Evidence standards framework for digital health technologies

https://www.nice.org.uk/about/what-we-do/our-programmes/evidence-standards-framework-for-digital-health-technologies

 

Europe

 

European Medicines Agency (EMA)

  • post-authorisation

https://www.ema.europa.eu/en/human-regulatory/post-authorisation

 

Asia


China National Medical Products Administration

http://www.nmpa.gov.cn/WS04/CL2042/

Japan Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/english/pnavi_e-01.html

  • Office of Advanced Evaluation with Electronic Data

https://www.pmda.go.jp/english/review-services/reviews/advanced-efforts/0002.html