| Publication | Title | Contents |
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Regulations for Buildings and Facilities 
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Full text in English of the Enforcement Regulations of Pharmaceutical Affairs Law: Chapters 1 to 14-4: Regulations for Buildings and Facilities. Included are texts of the chapters for Pharmacies, Distributors of Drugs, and Distributors, Leasers and Repairers of Medical Devices; Manufacturers of Drugs, Quasi-drugs, Cosmetics and Medical Devices), formatted, indexed, annotated and hyperlinked. 37-page Medicinal Products Lifecycle document. |
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GQP Ordinance
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Full text in English of the MHLW Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices, MHLW Ordinance No. 136, September 22, 2004 (also known as the "Good Quality Practice Ordinance" or shortly as the "GQP Ordinance"). Formatted, indexed, annotated and hyperlinked. 20-page Medicinal Products Lifecycle document. |
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QMS Ordinance
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Full text in English of the MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents, MHLW Ordinance No. 169, December 17, 2004 (also known as the "Quality Management Systems Ordinance" or shortly as the "QMS Ordinance"). Formatted, indexed, annotated and hyperlinked. 51-page Medicinal Products Lifecycle document. |
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GMP Ordinance
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Full text in English of the MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs, MHLW Ordinance No. 179, December 24, 2004 (also known as the "Good Manufacturing Practice Ordinance" or shortly as the "GMP Ordinance"). Formatted, indexed, annotated and hyperlinked. 29-page Medicinal Products Lifecycle document. |
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| 1999-2006 | Japan Approvals Database (JAD)  |
The JAD database now includes new section - "Under Approval". Subscribe to the only English-language database of approved pharma products in Japan - available now at promotional price - more info |