English translations of Notifications on Implementation of Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Stuides of Drugs/Medical Devices

Notifications and Administrative Notices

The following English translations of Japanese notifications and administrative notices are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail.

Drugs

Issue Date Document Type & No. Title Subject
Sep. 6, 2012 PFSB/ELD
Administrative
Notice
PDF Basic Principles on Global Clinical Trials (Reference Cases) (PDF) Clinical trials
Apr. 18, 2012 PFSB/ELD
Administrative
Notice
PDF English Translations of the Guidance for Establishing Safety in First-in-Human Studies during Drug Development and its Questions and Answers (PDF) Clinical trials
Mar. 30, 2012 PFSB/ELD
Administrative
Notice
PDF On the Standard Review Timeline for New Drug Applications (PDF) Regulatory submission
Jan. 17, 2011 PFSB/ELD
Administrative
Notice
PDF Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time (PDF) Regulatory submission
July 9, 2010 PFSB/ELD Notification No. 0709-1 PDF On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents (PDF) Clinical trials
July 9, 2010 PFSB/ELD Administrative Notice PDF On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents (PDF) Clinical trials
June 9, 2010 PFSB/ELD-CND
Administrative
Notice
PDF Points to Consider for Reducing Total Review Time for New Drug Applications (PDF) Regulatory submission
Sep. 7, 2009 PFSB/ELD-SD Administrative Notice PDF Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs (PDF) Post-marketing safety
June 13, 2008 PFSB Notification No. 0613007 PDF Guidance on the Implementation of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs as Revised by the Ministerial Ordinance for the Partial Revision of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs (PDF) New GLP
Sep. 28, 2007 PFSB/ELD Notification No. 0928010 PDF Basic Principles on Global Clinical Trials (PDF) Clinical trials
Feb. 8, 2006 PFSB/ELD Notification No. 0208001 PDF Cancellation of items registered in Drug Master Files (PDF) DMF
Oct. 24, 2005 PFSB/ELD Notification No. 1024002 PDF Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs (PDF) Accreditation of foreign manufacturers
Mar. 30, 2005 PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005
PDF Handling of Applications for GMP Inspections (PDF) GMP
Feb. 10, 2005 PFSB/ELD Notification No. 0210001 PDF Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. under the Revised Pharmaceutical Affairs Law (PDF) Regulatory submission
Feb. 10, 2005 PFSB/ELD Notification No. 0210004 PDF Guideline on Utilization of Master File for Drug Substances, etc. (PDF) DMF

Medical Devices

Issue Date Document Type & No. Title Subject
Feb. 6, 2009 PMDA Notification No. 0206007 PDF Procedures for Public Release of Information on Review of Applications for New Medical Devices (PDF) Public release of information
June 13, 2008 PFSB Notification No. 0613010 PDF Guidance on the Implementation of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices as Revised by the Ministerial Ordinance for the Partial Revision of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices (PDF) New GLP
June 23, 2006 PFSB/ELD/
OMDE Administrative Notice
PDF Q & A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries (PDF) Regulatory submission
Mar. 31, 2006 PFSB/MDE Notification No. 0331006 PDF Handling of clinical study data on medical devices which was carried out in foreign countries (PDF) Regulatory submission
Mar. 30, 2005 PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005
PDF Handling of Applications for GMP Inspections (PDF) GMP (QMS)
Feb. 16, 2005 PFSB/ELD/
OMDE Notification No. 0216003
PDF Handbook for Preparation of Summary Technical Documentation Submitted in Applications for Marketing Approval for Medical Devices (PDF) Regulatory submission
Feb. 16, 2005 PFSB Notification No. 0216002 PDF Applications for Marketing Approval for Medical Devices (PDF) Regulatory submission
Feb. 16, 2005 PFSB/ELD/
OMDE Notification No. 0216001
PDF Points to Consider When Applying for Marketing Approval for Medical Devices (PDF) Regulatory submission
Feb. 13, 2003 PMSB/ELD Notification No. 0213001 PDF Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices (PDF) Regulatory submission
Mar. 31, 1997 PAB/MHW Notification No. 479 PDF Handling of the data of clinical studies for medical devices conducted in foreign countries (PDF) Regulatory submission

Pharmaceuticals and Medical Devices Agency

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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