Regulations for Buildings
and Facilities

Reports:
7_D_B001 | 7_D_B002

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 medicinal products ; Manufacturers of Drugs, Quasi-drugs, Cosmetics and medicinal products ), formatted, indexed, annotated and hyperlinked. 37-page Drugs Lifecycle document.

GQP Ordinance

Reports:
7_D_B003 | 7_D_B004 

Full text in English of the MHLW Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and medicinal products , 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 Drugs Lifecycle document.

QMS Ordinance

 Reports:
7_D_B005 | 7_D_B006 

Full text in English of the MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for medicinal products 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 Drugs Lifecycle document.

Drugs and medicinal products Safety Update Seminar 2005

 Reports:
JM_I_023 | JM_I_024

The report on "Drugs and medicinal products Safety Update Seminar" held in Tokyo on September 16, 2005 is compiled and published by Jouhou Koukai Publishing. For the first time in English the program and the key announcements, formatted, indexed, annotated and hyperlinked. 30-page Japan Monitor document.

22nd New Drug Evaluation Division Information Meeting

Reports:
JM_I_025 | JM_I_026

The report on "22nd New Drug Evaluation Division Information Meeting" held in Tokyo on October 19, 2005 is compiled and published by Jouhou Koukai Publishing. For the first time in English the program and the key announcements, formatted, indexed, annotated, hyperlinked and illustrated - 5 figures, over 10 editor's notes, references. 36-page Japan Monitor document.

PFSB No. 0520004

Reports:
7_D_K003 

Full translation of the PFSB Notification No. 0520004 dated May 20, 2003 "Manufacture and Quality Control of Drugs and medicinal products Originating from Living Organisms" on the revisions of the Manufacture and QC in handling of products originating from living organisms. 21-page document. Formatted, indexed and hyperlinked.

MHLW No. 210

Reports:
7_D_K004 

Full translation of the Notification No. 210 of the Minister of Health, Labor and Welfare dated May 20, 2003 on "Standards for Raw Materials Originating from Living Organisms", set to enter into force on October 30, 2003. 28-page document. Annotated, indexed and hyperlinked.