PMDA Meeting

This is the First and only reference book for PMDA consultation meetings.
PMDA meetings process is described from first contact through the finalization of minutes in a sequential manner. This is a must book to achieve a successful PMDA meeting.

Intended readers:

  • Global R&D project team members
  • Clinical leaders
  • Regulatory Affairs experts / consultants
  • CROs

Consultation Guide

TitleIssue datePagesPrice[¥]StatusRemark
First Complete Guide for PMDA Consultation Meeting [PM001]8/22/2018429,000
Complete Sets of Templates for PMDA Consultation Meetings [PM002]8/22/2018205,000
PM001 + PM002 [PM003]8/22/20185012,000

Quality

TitleIssue datePagesPrice[¥]StatusRemark
Guidance for a Bioequivalency Study for Manufacturing Method Change of Oral Products [QA001]4/19/20132020,000
Guidance for Quality Assessment of Antibody Drugs [QA002]12/14/20122222,000
Q&A for "Guidance for Quality Assessment of Antibody Drugs"
[QA003]
12/14/201222,000
Guidance for the Manufacturing of Sterile Products by Terminal Sterilization [QA004]11/9/20125252,000Shipped in 7 days
Standards for Manufacturing Control and Quality Control of Crude Drugs and Kanpo Drugs [QA005]2/16/20122222,000Shipped in 7 days
Standards for Manufacturing Control and Quality Control of Medical Use Gas (Self-standards) [QA006]2/13/20121515,000Shipped in 7 days
Handling of Ethical Products with Different Crystal Forms [QA007]6/16/201144,000
Guidance for the Manufacturing of Sterile Pharmaceutical Products by Aseptic Method [QA008]4/20/20118686,000Shipped in 7 days

Non-Clinical

TitleIssue datePagesPrice[¥]StatusRemark
Guideline for Non-Clinical Safety Studies Using Young Animals for Pediatric Pharmaceutical Products [NC001]10/2/201277,000Downloadable in 7 days
Q&A for "Guideline for Non-Clinical Safety Studies Using Young Animals for Pediatric Pharmaceutical Products" [NC002]10/2/201255,000Downloadable in 7 days
Guideline for Non-Clinical Assessment of Anti-Cancer Drugs (ICH) [NC003]6/2/201011Free
Guideline for Non-Clinical Assessment of Infection Prevention Vaccine [NC004]5/27/201066,000Downloadable in 7 days
Guideline for Non-Clinical Pharmacokinetic Studies [NC005]6/26/19986Free

Clinical

TitleIssue datePagesPrice[¥]StatusRemark
Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials [CL001]10/27/20146Free
Guideline for Data Monitoring Committee [CL002]4/4/20131111,000
Basic Principles on Global Clinical Trials (Reference Cases) [CL003]9/6/201212Free
Clinical Studies Utilizing Pharmacogenomics [CL004]9/30/200844,000
Guidance for Microdose Clinical Studies [CL005]6/3/20082121,000
Basic Principles on Global Clinical Trials [CL006]9/28/200711Free
Guideline for Appropriate Use of Pharmacotherapy for Pediatric Bronchial Asthma [CL007]7/27/20061414,000Downloadable in 7 days
Clinical Pharmacokinetic Studies for Pharmaceutical Products [CL008]6/1/20011818,000Downloadable in 7 days
Guideline for Clinical Evaluation of Antibiotics [CL101]10/23/20179595,000
Guidance for Clinical Evaluation of Traveler's Vaccine [CL102]4/7/201655,000Downloadable in 7 days
Guidance for Clinical Evaluation of Anti-Tumor Drugs for Pediatric Malignant Tumors [CL103]9/30/20151212,000
Guideline for Clinical Evaluation of Diagnostic Radioactivity Drugs
Partial Revision of the Guideline [CL104]
6/11/20122121,000
Guideline for Clinical Evaluation of Sleep Medicine [CL105]12/13/20111717,000
Guideline for Clinical Evaluation of Renal Anemia Drugs [CL106]9/30/20111414,000
Q&A for "Guideline for Clinical Evaluation of Renal Anemia Drugs" [CL107]9/30/201122,000
Guideline for Clinical Evaluation of Heart Failure Drugs [CL108]3/29/20112020,000
Q&A for "Guideline for Clinical Evaluation of Heart Failure Drugs" [CL109]3/29/201133,000
Guideline for Clinical Evaluation of Anti-Depression Drugs [CL110]11/16/20101717,000
Guideline for Clinical Evaluation of Oral Hypoglycemic Agents [CL111]7/9/201024Free
Q&A for "Guideline for Clinical Evaluation of Oral Hypoglycemic Agents" [CL112]7/9/20105Free
Guideline for Clinical Studies for Infection Prevention Vaccine [CL113]5/27/20101313,000Downloadable in 7 days
Guideline for Clinical Evaluation of Overactive Bladder [CL114]6/28/20061414,000
Q&A for "Guideline for Clinical Evaluation of Anti-Tumor Drugs" [CL115]3/1/200688,000Downloadable in 7 days
Guideline for Anti-Rheumatoid Drugs [CL116]2/17/20061515,000Downloadable in 7 days
Guideline for Clinical Evaluation of Anti-Tumor Drugs [CL117]11/1/20051010,000Downloadable in 7 days
Guideline for Clinical Evaluation of Anti-Angina Drugs [CL118]5/12/20041212,000Downloadable in 7 days
Guideline for Clinical Evaluation of Anti-Arrhythmia Drugs [CL119]3/25/200499,000Downloadable in 7 days
Guideline for Clinical Evaluation of Osteoporosis Drugs [CL120]4/15/19992424,000Downloadable in 7 days

Multidisciplinary

TitleIssue datePagesPrice[¥]StatusRemark
Guideline for Drug Interactions for Drug Development and Labeling Recommendations [MU001]7/23/20188484,000Downloadable in 7 days
Q&A for "Guideline for Drug Interactions for Drug Development and Labeling Recommendations" [MU002]7/23/20181818,000
Procedure for Manufacturing and Selling DNA Sequencer for Genetic Test System [MU003]4/28/201633,000Downloadable in 7 days
Q&A for "Procedure for Manufacturing and Selling DNA Sequencer for Genetic Test System" [MU004]1/26/201722,000Downloadable in 7 days
Guidance for Environmental Impact Assessment for New Drug Development [MU005]3/30/201677,000Downloadable in 7 days
Guideline for the Development of Liposome Formulation [MU006]3/28/20162222,000Downloadable in 7 days
Q&A for "Guideline for the Development of Liposome Formulation" [MU007]3/28/201633,000Downloadable in 7 days
Reflection Paper for Nano Formulation Loaded with Nucleic Acids (siRNA) [MU008]3/28/20168Free
Guideline for PK/PD of Antibiotics [MU009]12/25/20151717,000Downloadable in 7 days
Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development [MU010]4/1/201421Free
Q&A for "Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development" [MU011]4/1/20146Free
Points to Consider When Submitting Market Authorization of In Vitro Diagnostics Classified as Companion Drug, etc. [MU012]3/28/201433,000Downloadable in 7 days
Q&A for "Points to Consider When Submitting Market Authorization of In Vitro Diagnostics Classified as Companion Drug, etc." [MU013]2/19/201433,000Downloadable in 7 days
Joint Reflection Paper for the Development of Block Co-Polymer Micelle Drugs by PMDA and EMA [MU014]1/10/201416Free
Q&A for "Joint Reflection Paper for the Development of Block Co-Polymer Micelle Drugs by PMDA / EMA" [MU015]1/10/20144Free
Technical Guidance for Companion Drugs and Related Pharmaceutical Products [MU016]12/26/201344,000Downloadable in 7 days
Guideline on Bioanalytical Method Validation in Pharmaceutical Development [MU017]7/11/201325Free
Q&A for "Guideline on Bioanalytical Method Validation in Pharmaceutical Development" [MU018]7/11/20135Free
Points to Consider for Market Authorizqtion of Companion Diagnostic Drugs and Related Pharmaceutical Products [MU019]7/1/201344,000Downloadable in 7 days
Q&A for "Points to Consider for Market Authorizqtion of Companion Diagnostic Drugs and Related Pharmaceutical Products" [MU020]7/1/201333,000Downloadable in 7 days
Guidance For Establishing Safety in First-in-Human Studies during Drug Development [MU021]4/2/201221Free
Q&A for "Guidance For Establishing Safety in First-in-Human Studies during Drug Development" [MU022]4/2/20124Free
Guideline for the Development of Prototype Vaccine for the Preparedness for Pandemic Influenza [MU023]10/31/20111010,000Downloadable in 7 days

Generics

Doc. IDTitleDate of issue# of pagesPrice($)StatusRemark
GE001Coming soon (On demand translation)

Biosimilar

TitleIssue datePagesPrice[¥]StatusRemark
Q&A for Guidance to Ensure Quality, Safety and Effiacy of Biosimilars [BS001]12/15/201555,000
Guidance for Non-Proprietary Name and Brand Name for Biosimilars [BS002]2/14/201333,000
Q&A for Guidance for Quality, Safety and Effiacy of Biosimilars [BS003]3/31/201033,000
Q&A for Guidance for Quality, Safety and Effiacy of Biosimilars [BS004]7/21/200933,000
Guidance to Ensure Quality, Safety and Effiacy of Biosimilars [BS005]3/4/20091616,000

OTC

Quasi-Pharmaceutical

In vitro Diagnostics

Regenerative Medicine

TitleIssue datePagesPrice[¥]StatusRemark
Market Athorization Procedure for Regenerative Medicine [RM001]N/A1515,000
Technical Guidance for Quality, Non-Clinical Studies and Clinical Studies of Regenerative Medicine Products (Human Cell Processed Products) [RM002]6/27/20162323,000
Checkpoint for Efficiant Regulatory Strategy Meeting for Regenerative Medicine Products: Quality [RM003]3/8/20131010,000
Checkpoint for Efficiant Regulatory Strategy Meeting for Regenerative Medicine Products: Sterility test and myocoplasma test [RM004]1/17/201422,000
Checkpoint for Efficiant Regulatory Strategy Meeting for Regenerative Medicine Products: Non-clincal safety [RM005]3/8/201333,000
Key Points for the Submission of Initial Clinical Trial Notification of Regenerative Medicine Product  (Powerpoint) [RM006]N/A44,000

Medical Devices

Doc. IDTitleDate of issue# of pagesPrice($)StatusRemark
MD001Coming soon (On demand translation)

Pharmacovigilance

Doc. IDTitleDate of issue# of pagesPrice($)StatusRemark
SM001Coming soon (On demand translation)

Japan Clinical Guidelines

TitleIssue datePagesPrice[¥]StatusRemark
OAB treatment algorythm [OAB01]2015104,000
IBS Treatment Algorythm [IBS01]201474,000