1. Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Pharmaceuticals and Quasi-drugs (MHLW Ordinance No.179, of 24 December, 2004) (Tentative Translation: as of September 9, 2005; https://www.pmda.go.jp/files/000153399.pdf).
2. Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Regenerative medicines (MHLW Ordinance No.93 of 6 August, 2014).
3. Guidance on Handling of Application for GMP Compliance Inspection (Notification 0702 No.1 of 2015 of the PFSB/ELD and CND).
4. Guidance on GCTP/GQP/regulations for buildings and facilities (Notification 1009 No.1 of 2014 of the PFSB/CND).
5. Pages 42–45, Document 1–1 of the 2nd Subcommittee on Pharmaceutical and Medical Device Regulatory System in 2018, Health Science Council, MHLW About the current conditions and problem on theme 1 (securing early access to innovative medicine, medical equipment, enhancement of safety measures).