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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
Oct. 20, 2017 PSEHB/PED Notification  No. 1020-1 Implementation of a Conditional Early Approval System for Pharmaceutical Products Regulatory submission
Sep. 15, 2017 PSEHB/PED Notification  No. 0915-1
HIB/MED Notification  No. 0915-1
Handling of the Optimal Clinical Use Guidelines Regulatory submission
Jun. 20, 2014 PFSB/ELD
Notification
No. 0620-6
Basic Principles on Electronic Submission of Study Data for New Drug Applications Electronic Data Promotion
Jun. 20, 2014 PFSB/ELD
Administrative Notice
Question and Answer Guide Regarding "Basic Principles on Electronic Submission of Study Data for New Drug Applications" Electronic Data Promotion
July 1, 2013 PFSB/ELD
Administrative
Notice
Basic Principles of Risk-based Monitoring Clinical trials
Sep. 5, 2012 PFSB/ELD
Administrative
Notice
Basic Principles on Global Clinical Trials (Reference Cases) Clinical trials
Apr. 18, 2012 PFSB/ELD
Administrative
Notice
English Translations of the Guidance for Establishing Safety in First-in-Human Studies during Drug Development and its Questions and Answers Clinical trials
Mar. 30, 2012 PFSB/ELD
Administrative
Notice
On the Standard Review Timeline for New Drug Applications Regulatory submission
Jan. 17, 2011 PFSB/ELD
Administrative
Notice
Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time Regulatory submission
July 9, 2010 PFSB/ELD Notification No. 0709-1 On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents Clinical trials
July 9, 2010 PFSB/ELD Administrative Notice On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents Clinical trials
June 9, 2010 PFSB/ELD-CND
Administrative
Notice
Points to Consider for Reducing Total Review Time for New Drug Applications Regulatory submission
Sep. 7, 2009 PFSB/ELD-SD Administrative Notice Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs Post-marketing safety
Mar. 4, 2009 PFSB/ELD Notification No. 0304007 Guideline for the Quality, Safety and Efficacy Assurance of Follow-on Biologics Regulatory submission
June 13, 2008 PFSB Notification No. 0613007 Guidance on the Implementation of the Ministerial Ordinance on the Good Laboratory Practice for Nonclinical Safety Studies of Drugs as Revised by the Ministerial Ordinance for the Partial Revision of the Ministerial Ordinance on the Good Laboratory Practice for Nonclinical Safety Studies of Drugs GLP
Sep. 28, 2007 PFSB/ELD Notification No. 0928010 Basic Principles on Global Clinical Trials Clinical trials
Feb. 8, 2006 PFSB/ELD Notification No. 0208001 Cancellation of items registered in Drug Master Files DMF
Oct. 24, 2005 PFSB/ELD Notification No. 1024002 Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs Accreditation of foreign manufacturers
Mar. 30, 2005 PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005
Handling of Applications for GMP Inspections GMP
Feb. 10, 2005 PFSB/ELD Notification No. 0210001 Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. under the Revised Pharmaceutical Affairs Law Regulatory submission
Feb. 10, 2005 PFSB/ELD Notification No. 0210004 Guideline on Utilization of Master File for Drug Substances, etc. DMF

 

Medical Devices

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

 

JCN 3010005007409

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

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Notifications and Administrative Notices
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