North America
Food & Drug Administration (FDA)
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-fiscal-years-2018-2022
https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Health Canada
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
https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity
UK National Institute for Health and Care Excellence (NICE)
Europe
European Medicines Agency (EMA)
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
https://www.pmda.go.jp/english/review-services/reviews/advanced-efforts/0002.html