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

• Considerations for the Utilization of Master Protocol Trials in Drug Development[303KB]

June 20, 2024
Administrative Notice

 

• Partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults"[102KB]

March 29, 2024
PSB/PED Notification No. 0329-1

 

• Q&A for “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”[140KB]

March 29, 2024
Administrative Notice

 

• Partial Revision of “Designation of Orphan Drugs etc.”[155KB]

January 16, 2024
PSB/PED Notification No. 0116-1・PSB/MDED Notification No. 0116-1

 

• Questions and Answers (Q&A) for Designation of Orphan Drugs etc.[104KB]

January 16, 2024
Administrative Notice

 

• Partial Revision of “Handling of Re-Examination Period”[94.7KB]

January 16, 2024
PSB/PED Notification No. 0116-3

 

• Planning of the Pediatric Drug Development Program during Development of Drugs for Adults[65.7KB]

January 12, 2024
PSB/PED Notification No. 0112-3

 

• Basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan[244.40KB]

December 25, 2023
PSB/PED Notification No. 1225-2

 

• Q&A for basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan[119.18KB]

December 25, 2023
PSB/PED Administrative Notice

 

• Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products[197.21KB]

July 3, 2023
PMDA/CPE Notification No. 325

 

• Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials[104.50KB]

March 30, 2023
PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1

 

• 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[201.63KB]

September 14, 2022
PSEHB/PED Administrative Notice

 

• Questions and Answers (Q&A) on "Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics"[46.44KB]

June 9, 2022
PSEHB/PED Administrative Notice

 

• Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products[110.34KB]

May 25, 2022
PMDA/CPE Notification No. 0525001

 

• Amendment to “Basic Principles on Global Clinical Trials (Reference Cases)”[431.73KB]

December 10, 2021
PSEHB/PED Administrative Notice

 

• English Translations of Guidelines for Bioequivalence Studies of Generic Products[362.45KB]

September 14, 2021
PSEHB/PED Administrative Notice

 

• Basic Concept on Bioequivalence Evaluation for Addition of Formulations with Different Dosage Forms in Ethical Kampo Formulations[416.05KB]

July 19, 2021
PSEHB/PED Administrative Notice

 

• Basic principles on Utilization of Registry for Applications[362.43KB]

March 23, 2021
PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1

 

• Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications[495.56KB]

March 23, 2021
PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2

 

• Guidelines for Analysis Reports Involving Physiologically based Pharmacokinetic Models[405.59KB]

December 21, 2020
PSEHB/PED Notification No. 1221-1

 

• Questions and Answers (Q&A) for Extension of Re-Examination Period in Association with Development of Pediatric Dosage and Administration[73.3KB]

November 26, 2020
Administrative Notice

 

• Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products[277.43KB]

November 16, 2020
PMDA/CPE Notification No. 1116002

 

• Handling of Designation of Drugs for Specific Use[105KB]

August 31, 2020
PSEHB/PED Notification No. 0831-5

 

• Re-Examination Period of Prescription Drugs[94.4KB]

August 31, 2020
PSEHB Notification No. 0831-11

 

• 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[313.96KB]

June 30, 2020
PSEHB/PED Administrative Notice

 

• Guideline for preclinical safety assessment of oligonucleotide therapeutics[291.92KB]

March 30, 2020
PSEHB/PED Notification No. 0330-1

 

• Guideline for Exposure-Response Analysis of Drugs[741.29KB]

June 8, 2020
PSEHB/PED Administrative Notice

 

• Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis[383.35KB]

June 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[454.83KB]

June 19, 2019
PSEHB/PED Administrative Notice

 

• Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics[155.72KB]

September 27, 2018
PSEHB/PED Notification No. 0927-3

 

• Partial Revision of New “Standard Forms for requesting clinical trials, etc.”[158.70KB]

July 10, 2018
HPB/RDD Notification No. 0710-4
PSEHB/PED Notification No. 0710-2
PSEHB/MDED Notification No. 0710-2

 

• New “Standard Forms for Requesting Clinical Trials, etc.”[807.13KB]

July 10, 2018

 

• Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs[462.39KB]

February 21, 2018
PSEHB/PED Notification No. 0221-1

 

• Guideline for Clinical Evaluation of Antibacterial Drugs[906.39KB]

October 23, 2017
PSEHB/PED Notification No. 1023-3

 

• Implementation of a Conditional Early Approval System for Pharmaceutical Products[300.82KB]

October 20, 2017
PSEHB/PED Notification No. 1020-1

 

• Handling of the Optimal Clinical Use Guidelines[353.70KB]

September 15, 2017
PSEHB/PED Notification No. 0915-1
HIB/MED Notification No. 0915-1

 

• Clinical Trials Conducted on Ethical Grounds-Japanese Compassionate Use System-[392.52KB]

January 22, 2016
PSEHB/ELD Notification No. 0122-7

 

• Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials[44.11KB]

October 27, 2014
PFSB/ELD Administrative Notice

 

• Basic Principles on Electronic Submission of Study Data for New Drug Applications[55.82KB]

June 20, 2014
PFSB/ELD Notification No. 0620-6

 

• Question and Answer Guide Regarding "Basic Principles on Electronic Submission of Study Data for New Drug Applications"[64.59KB]

June 20, 2014
PFSB/ELD Administrative Notice

 

• Basic Principles of Risk-based Monitoring[17.92KB]

July 1, 2013
PFSB/ELD Administrative Notice

 

• Guideline on Data Monitoring Committee[198.41KB]

April 4, 2013
PFSB/ELD Notification No. 0404-1

 

• Basic Principles on Global Clinical Trials (Reference Cases)[89.69KB]

September 5, 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[263.18KB]

April 18, 2012
PFSB/ELD Administrative Notice

 

• On the Standard Review Timeline for New Drug Applications[111.86KB]

March 30, 2012
PFSB/ELD Administrative Notice

 

• Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time[186.25KB]

January 17, 2011
PFSB/ELD Administrative Notice

 

• On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents[156.49KB]

July 9, 2010
PFSB/ELD Notification No. 0709-1

 

• On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents[73.82KB]

July 9, 2010
PFSB/ELD Administrative Notice

 

• Points to Consider for Reducing Total Review Time for New Drug Applications[38.26KB]

June 9, 2010
PFSB/ELD-CND Administrative Notice

 

• Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs[90.48KB]

September 7, 2009
PFSB/ELD-SD Administrative Notice

 

• 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[82.46KB]

June 13, 2008
PFSB Notification No. 0613007

 

• Basic Principles on Global Clinical Trials[188.76KB]

September 28, 2007
PFSB/ELD Notification No. 0928010

 

• Cancellation of items registered in Drug Master Files[139.70KB]

February 8, 2006
PFSB/ELD Notification No. 0208001

 

• Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs[32.81KB]

October 24, 2005
PFSB/ELD Notification No. 1024002

 

• Handling of Applications for GMP Inspections[70.72KB]

March 30, 2005
PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005

 

• Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. under the Revised Pharmaceutical Affairs Law[728.95KB]

February 10, 2005
PFSB/ELD Notification No. 0210001

 

• Guideline on Utilization of Master File for Drug Substances, etc.[282.81KB]

February 10, 2005
PFSB/ELD Notification No. 0210004

Biosimilars

• Guideline for Ensuring Quality, Safety, and Efficacy of Biosimilars[150KB]

February 4, 2020
PSEHD/PED Notification No. 0204-1

 

• Questions and Answers (Q&A) on Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars[200KB]

January 25, 2024
PSB/PED Administrative Notice

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Medical Devices

• Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials[104.50KB]

March 30, 2023
PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1

 

• Partial Revision of the “Points to Consider for Approval Applications for Home Medical Devices to Detect Signs of Diseases and to Encourage Medical Consultation”[127.54KB]

December 13, 2022
PSEHB/MDED Notification No. 1213-4
PSEHB/PSD Notification No. 1213-3

 

• Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing Medical Image Data without Involvement of Additional Invasiveness or Intervention[43.42KB]

September 29, 2021
PSEHB/MDED Notification No.0929-1

 

• Basic principles on Utilization of Registry for Applications[362.43KB]

March 23, 2021
PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1

 

• Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications[495.56KB]

March 23, 2021
PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2

 

• Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices[462.43KB]

December 19, 2018
PSEHB/MDED Notification No. 1219-4

 

• 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)[465.22KB]

November 17, 2017
PSEHB/MDED Notification No.1117-1
PSEHB/SD Notification No.1117-1

 

• Release of Clinical Trial Guidance to Facilitate the Speedy and Accurate Approval and Development of Medical Devices[601.46KB]

November 17, 2017
PSEHB/MDED Administrative Notice

 

• Points to Consider for Preparation of Attached Data to Application Form for Marketing Approval of Reprocessed Single-use Medical Devices[178.85KB]

August 16, 2017
PSEHB/MDE Notification No. 0816-6

 

• Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices[226.02KB]

August 16, 2017
PSEHB/MDE Notification No. 0816-3

 

• Points to Consider for Reprocessed Single-use Medical Devices[163.01KB]

July 31, 2017
PSEHB/MDE Notification No. 0731-8
PSEHB/PSD Notification No. 0731-5
PSEHB/CND Notification No. 0731-1

 

• 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)[165.58KB]

July 31, 2017
PSEHB/CND Notification No. 0731-12

 

• 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)[156.81KB]

July 31, 2017
PSEHB Notification No. 0731-7

 

• Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme)[280.09KB]

July 31, 2017
PSEHB Notification No. 0731-1

 

• Notice concerning the Publication of Guidance Materials concerning Application for Marketing Approval of Medical Device Software[205.00KB]

March 31, 2016
PFSB/MDRMPED Administrative Notice

 

• 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)[91.07KB]

February19, 2015
PFSB/MDRMPED Notification No. 0219-1

 

• Questions & Answers about Handling of Medical Device Software[136.76KB]

November 25, 2014
PFSB/MDRMPED Administrative Notice

 

• Handling of Application for Marketing Certification of Medical Device Software[90.81KB]

November 25, 2014
PFSB/MDRMPED Notification No. 1125-6

 

• Handling of Medical Device Software[113.60KB]

November 21, 2014
PFSB/MDRMPED Notification No. 1121-33
PFSB/SD Notification No. 1121-1
PFSB/CND Notification No. 1121-29

 

• Procedures for Public Release of Information on Review of Applications for New Medical Devices[59.25KB]

February 6, 2009
PMDA Notification No. 0206007

 

• 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[84.88KB]

June 13, 2008
PFSB Notification No. 0613010

 

• Q & A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries[54.35KB]

June 23, 2006
PFSB/ELD/ OMDE Administrative Notice

 

• Handling of clinical study data on medical devices which was carried out in foreign countries[23.64KB]

March 31, 2006
PFSB/MDE Notification No. 0331006

 

• Handling of Applications for GMP Inspections[70.72KB]

March 30, 2005
PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005

 

• Handbook for Preparation of Summary Technical Documentation Submitted in Applications for Marketing Approval for Medical Devices[144.35KB]

February 16, 2005
PFSB/ELD/ OMDE Notification No. 0216003

 

• Applications for Marketing Approval for Medical Devices[117.27KB]

February 16, 2005
PFSB Notification No. 0216002

 

• Points to Consider When Applying for Marketing Approval for Medical Devices[252.94KB]

February 16, 2005
PFSB/ELD/ OMDE Notification No. 0216001

 

• Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices[126.33KB]

February 13, 2003
PFSB/ELD Notification No. 0213001

 

• Handling of the data of clinical studies for medical devices conducted in foreign countries[24.17KB]

March 31, 1997
PAB/MHW Notification No. 479

 

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Regenerative Medical Products

• Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products[197.21KB]

July 3, 2023
PMDA/CPE Notification No. 325

 

• 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[601.79KB]

March 31, 2023
PSEHB/MDED Administrative Notice

 

• Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials[104.50KB]

March 30, 2023
PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1

 

• Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products[110.34KB]

May 25, 2022
PMDA/CPE Notification No. 0525001

 

• Basic principles on Utilization of Registry for Applications[362.43KB]

March 23, 2021
PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1

 

• Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications[495.56KB]

March 23, 2021
PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2

 

• Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products[277.43KB]

November 16, 2020
PMDA/CPE Notification No. 1116002

 

• Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Regenerative Medical Products[464.08KB]

March 23, 2020
PSEHB/MDED Notification No. 0323-4

 

• Guideline on Ensuring the Quality and Safety of Gene Therapy Products[438.21KB]

July 9, 2019
PSEHB/MDED Notification No.0709-2

 

• Guidelines on Cancer Immunotherapy Development[901.47KB]

March 8, 2019
PSEHB/PED Notification No. 0308-1
PSEHB/MDED Notification No.0308-1

 

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In Vitro Diagnostics

• Points to Consider When Applying for Marketing Approval of In Vitro Diagnostics[299.86KB]

November 21, 2014
PFSB/ELD/OMDE Notification No. 1121-16

 

• Applications for Marketing Approval of In Vitro Diagnostics[143.88KB]

November 21, 2014
PFSB Notification No. 1121-15

 

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