Issue Date |
Document Type & No. |
Title |
Subject |
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 |
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 |
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 |