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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. The PMDA shall not be responsible for any consequence resulting from use of the English version.
 

Drugs

Medical Devices

Regenerative Medical Products

In Vitro Diagnostics

 

Drugs

Issue Date Document Type & No. Title Subject
Jul. 3, 2023 PMDA/CPE Notification No. 325 Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products GCP, GPSP
Mar. 30, 2023 PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1		 Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials Clinical trials
Sep. 14, 2022 PSEHB/PED Administrative Notice Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Drugs Regulatory submission, 
GCP, GPSP
Jun. 9, 2022 PSEHB/PED Administrative Notice Questions and Answers (Q&A) on "Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics" Regulatory submission
May 25, 2022 PMDA/CPE Notification No. 0525001 Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products GCP, GPSP
Dec. 10, 2021 PSEHB/PED Administrative Notice Amendment to “Basic Principles on Global Clinical Trials (Reference Cases)” Clinical trials
Sep. 14, 2021 PSEHB/PED Administrative Notice English Translations of Guidelines for Bioequivalence Studies of Generic Products Bioequivalence, Regulatory submission
Jul. 19, 2021 PSEHB/PED Administrative Notice Basic Concept on Bioequivalence Evaluation for Addition of Formulations with Different Dosage Forms in Ethical Kampo Formulations Bioequivalence, Regulatory submission
Mar. 23, 2021 PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1		 Basic principles on Utilization of Registry for Applications Regulatory submission
Mar. 23, 2021 PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2		 Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications Regulatory submission
Dec. 21, 2020 PSEHB/PED Notification No. 1221-1 Guidelines for Analysis Reports Involving Physiologically based Pharmacokinetic Models Clinical trials,
Regulatory submission
Nov. 16, 2020 PMDA/CPE Notification No. 1116002 Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products GCP, GPSP
Jun. 30, 2020 PSEHB/PED
Administrative Notice		 Considerations for the Clinical Evaluation of Drugs in Pediatric Patients (10 or 12 Years of Age and Older) Who Can be Evaluated Together with Adults Clinical trials
Mar. 30, 2020 PSEHB/PED Notification No. 0330-1 Guideline for preclinical safety assessment of oligonucleotide therapeutics Regulatory submission
Jun. 8, 2020 PSEHB/PED
Administrative Notice		 Guideline for Exposure-Response Analysis of Drugs Clinical trials,
Regulatory submission
Jun. 19, 2019 PSEHB/PED
Administrative Notice		 Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis Clinical trials,
Regulatory submission
Jun. 19,
2019		 PSEHB/PED
Administrative Notice		 Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs Regulatory submission,
Real world data, GPSP
Sep. 27, 2018 PSEHB/PED Notification No. 0927-3 Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics Regulatory submission
Jul. 10, 2018 HPB/RDD Notification No. 0710-4
PSEHB/PED Notification No. 0710-2
PSEHB/MDED Notification No. 0710-2		 Partial Revision of New “Standard Forms for requesting clinical trials, etc.”

New “Standard Forms for Requesting Clinical Trials, etc.”		 Regulatory submission
Feb. 21, 2018 PSEHB/PED Notification No. 0221-1 Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs Regulatory submission,
Real world data, GPSP
Oct. 23, 2017 PSEHB/PED Notification No. 1023-3 Guideline for Clinical Evaluation of Antibacterial Drugs Clinical trials
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
Jan. 22, 2016 PSEHB/ELD Notification No. 0122-7 Clinical Trials Conducted on Ethical Grounds
-Japanese Compassionate Use System-		 Clinical trials
Oct.27,
2014		 PFSB/ELD
Administrative Notice		 Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials Clinical trials
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
Jul. 1, 2013 PFSB/ELD
Administrative
Notice		 Basic Principles of Risk-based Monitoring Clinical trials
Apr. 4, 2013 PFSB/ELD
Notification
No. 0404-1		 Guideline on Data Monitoring Committee 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
Jul. 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
Jun. 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
Jun. 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

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Medical Devices

Issue Date Document Type & No. Title Subject
Mar. 30, 2023 PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1		 Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials Clinical trials
Dec. 13, 2022 PSEHB/MDED Notification No. 1213-4
PSEHB/PSD Notification No. 1213-3		 Partial Revision of the “Points to Consider for Approval Applications for Home Medical Devices to Detect Signs of Diseases and to Encourage Medical Consultation” Regulatory submission
Sep. 29, 2021 PSEHB/MDED Notification No.0929-1 Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing Medical Image Data without Involvement of Additional Invasiveness or Intervention Regulatory submission
Mar. 23, 2021 PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1		 Basic principles on Utilization of Registry for Applications Regulatory submission
Mar. 23, 2021 PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2		 Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications Regulatory submission
Dec. 19, 2018 PSEHB/MDED Notification No. 1219-4 Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices Regulatory submission,
Real world data, GPSP
Nov. 17, 2017 PSEHB/MDED Notification No.1117-1
PSEHB/SD Notification No.1117-1		 Handling on the Scope of Situations where “Documents related to Clinical Study Results” is Necessary on Medical Devices (Operations based on Measures through Pre-and Post-Marketing Phases) Regulatory submission
Nov. 17, 2017 PSEHB/MDED Administrative Notice Release of Clinical Trial Guidance to Facilitate the Speedy and Accurate Approval and Development of Medical Devices Regulatory submission
Aug. 16, 2017 PSEHB/MDE Notification No. 0816-6 Points to Consider for Preparation of Attached Data to Application Form for Marketing Approval of Reprocessed Single-use Medical Devices Regulatory submission
Aug. 16, 2017 PSEHB/MDE Notification No. 0816-3 Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices Regulatory submission
Jul. 31, 2017 PSEHB/MDE Notification No. 0731-8
PSEHB/PSD Notification No. 0731-5
PSEHB/CND Notification No. 0731-1		 Points to Consider for Reprocessed Single-use Medical Devices Regulatory submission
Jul. 31, 2017 PSEHB/CND Notification No. 0731-12 Amendment of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostics related to reprocessed single-use medical devices (R-SUDs) Regulatory submission
Jul. 31, 2017 PSEHB Notification No. 0731-7 Amendment of the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics related to Reprocessed Single-Use Medical Devices (R-SUDs) Regulatory submission
Jul. 31, 2017 PSEHB Notification No. 0731-1 Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme) Regulatory submission
Mar. 31, 2016 PFSB/MDRMPED
Administrative Notice		 Notice concerning the Publication of Guidance Materials concerning Application for Marketing Approval of Medical Device Software Regulatory submission
Feb.19, 2015 PFSB/MDRMPED Notification No. 0219-1 Actions concerning Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software (terminating on February 24, 2015) Regulatory submission
Nov. 25, 2014 PFSB/MDRMPED
Administrative Notice		 Questions & Answers about Handling of Medical Device Software Regulatory submission
Nov. 25, 2014 PFSB/MDRMPED Notification No. 1125-6 Handling of Application for Marketing Certification of Medical Device Software Regulatory submission
Nov. 21, 2014 PFSB/MDRMPED Notification No. 1121-33
PFSB/SD Notification No. 1121-1
PFSB/CND Notification No. 1121-29		 Handling of Medical Device Software Regulatory submission
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
Jun. 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
Jun. 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

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Regenerative Medical Products

Issue
Date		 Document Type
& No.		 Title Subject
Jul. 3, 2023 PMDA/CPE Notification No. 325 Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products GCP, GPSP
Mar. 30, 2023 PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1
Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials
 Clinical trials
Mar. 31, 2023 PSEHB/MDED
Administrative Notice		 Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Regenerative Medical Products Regulatory submission, GCP, GPSP
May 25, 2022 PMDA/CPE Notification No. 0525001 Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products GCP, GPSP
Mar. 23, 2021 PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1		 Basic principles on Utilization of Registry for Applications Regulatory submission
Mar. 23, 2021 PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2		 Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications Regulatory submission
Nov. 16, 2020 PMDA/CPE Notification No. 1116002 Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products GCP, GPSP
Mar. 23, 2020 PSEHB/MDED Notification No. 0323-4 Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Regenerative Medical Products Regulatory submission,
Real world data, GPSP
Jul. 9, 2019 PSEHB/MDED Notification No.0709-2 Guideline on Ensuring the Quality and Safety of Gene Therapy Products Regulatory submission
Mar. 8, 2019 PSEHB/PED Notification No. 0308-1
PSEHB/MDED Notification No.0308-1		 Guidelines on Cancer Immunotherapy Development Regulatory submission

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In Vitro Diagnostics

Issue Date Document Type & No. Title Subject
Nov. 21, 2014 PFSB/ELD/OMDE
Notification No. 1121-16

PFSB Notification No. 1121-15		 Points to Consider When Applying for Marketing Approval of In Vitro Diagnostics


Applications for Marketing Approval of In Vitro Diagnostics		 Regulatory submission

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Chiyoda-ku, Tokyo 100-0013 Japan

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