1. Law No. 145 in 1960 Law to Ensure Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices. Available from: http://www.japaneselawtranslation.go.jp/law/detail/?vm=04&re=01&id=3213
2. MHLW Ordinance No. 171 in 2004: Ministerial Ordinance for Good Post-Marketing Surveillance and Clinical Studies. Available from: https://www.pmda.go.jp/review-services/inspections/reexam-reeval/0004.html
3. MHLW Ordinance No. 116 in 2017: Ministerial Ordinance to revise “Ministerial Ordinance for Good Post-Marketing Surveillance and Clinical Studies” Available from: https://www.pmda.go.jp/review-services/inspections/reexam-reeval/0004.html
4. Pharmaceutical Administration and Regulations in Japan (whole document). Japan Pharmaceutical Manufacturers Association.2018. Available from: http://www.jpma.or.jp/english/parj/whole.html
5. Re: Q&A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs. Administrative Notice September 7, 2009. Available from: https://www.pmda.go.jp/english/safety/regulatory-info/0001.html