Efforts toward the realization of Industrial Vision 2035

Revision of Transparency Guideline for the Relation between Corporate Activities and Medical Institutions

Open Call for Researchers Support and Grants "FY2025 Adoption Results" is now available.

Report on the Actual Situation Concerning Publication in MA" is now available.

Toward the Utilization of Structured Data for Clinical Trial Notification" is now available.

JPMA Rare Disease Day 2026 Symposium" Report Video and Report are now available.

Checklist for Voluntary Quality Tests_ver.1" is now available.

Presentation Material for Asian eCTD / Gateway System Information Symposium" is now available.

Notes on TMF Data Migration" is now available.

Q&A on Application for Authorized Users of the Next Generation Medical Infrastructure Act" is now available.

Briefing on Detailed Questionnaire Used for Adverse Reaction Surveillance (JPMA Electronic Model)" is now available.

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

The industry's first Scope 3 guidelines were released at the "Ministry of the Environment Model Project Outcome Debriefing Session.

The English version of the report "Evolution and Advancement of Data Management in Drug Development(Executive Summary)" is now available.

The "Actual Conditions and Challenges of DB Research in MA: A Comprehensive Analysis (FY2025)" is now available.

The following pages are released: "[Interview with a Patient Organization] Small Questions Create the Future: Opening the Door to Participation and Collaboration - Support familia Yamaguchi for Intractable Diseases" (Japanese only).

Report on "The 5th Japan-Vietnam Joint Symposium" is now available.

The article "Toward the Use of Wearable Devices" is now available.

Proposal for holding the "Workshop on the Implementation of the Clinical Trials Ecosystem Industry Declaration 2025"" is now available.

Pathways from Development to Access to Innovation (IDAP)" is now available.

Information and background necessary for companies to utilize disease registries" is now available.

Survey on Communication Issues at the Time of DCT Introduction" is now available.

2025 Assembly of the Clinical Evaluation Subcommittee, Part 1: Presentation Materials" is posted.

Report on Results of Questionnaire Survey on Companies' Current Perceptions of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency (February 2026)" is posted.

The symposium "Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials" is now available for viewing in advance.

The "Impact of the "Study Group on Regulation of Pharmaceutical Affairs to Enhance Drug Discovery and Ensure Stable Supplies of Drugs" related notifications as revealed through the results of a survey conducted in the pharmaceutical industry" is now available.

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

Report on "CMC Strategy Forum Japan 2025" is now available.

Proposal on Intractable and Rare Diseases Based on the Survey of Healthcare Professionals' Concerns

The following pages are released: "Hands-on Workshop for Utilization of Medical Information Databases in PV Activities: Video Lecture by Dr. Chieko Ishiguro" (Japanese).

The Third Annual Neglected Tropical Diseases Contest is Held

Information on "Symposium on Pediatric Drug Development on March 17, 2026" is now available.

Implementation of the webinar "Toward the Formation of a Global Community to Promote Research and Development of Antimicrobial Agents" was featured on the INCATE website.

First Report on the Judging of the Senden Kaigi Award in the Junior High and High School Student Category

JPMA and AMED "Joint Press Conference" Report is now available.

JPMA Q&A on the Clinical Research Act and Enforcement Regulations of the Clinical Research Act" is now available.

QMS in PV" is now available.

Report on "ICH Singapore Meeting" is now available.

Report on "The 5th Seminar on Economic Security" is posted.

Mapping of Clinical Trial Documents in TMF Reference Model (Revised Version)" is available.

The 148th Assembly of the Drug Evaluation Committee" is posted.

Asian eCTD / Gateway System Information" was added.

Report on "The 52nd GMP Case Study Workshop in 2025" is now available.

Results of Questionnaire on Information Provision Activities at the Time of Precautionary Statements Revision" is posted.

Special Session at the "12th Nikkei-FT Conference on Infectious Diseases

The following pages are released: "A Review of the First 10 Years since the Introduction of the RMP System from the Pharmaceutical Industry's Perspective" (Japanese only)

Slides for eCTD v4 Implementation Promotion Symposium (JPMA Presentation)" is available.

DX Lecture Slides (19th Annual Assembly of the Japanese Society of Pharmacy)" is available.

Preliminary Study on Application of AI to Quality Management of Clinical Trials" is posted.

R & D Committee Member Companies' R&D Needs" has been updated.

The following pages are released: "Data Linkage Concept: Data Linkage from the Perspective of Overseas Regulations" (Japanese)

The "Guide to Conducting Post-Marketing Database Surveillance - November 2025 Edition" is now available.

The following pages are released / updated: "Evolution and Deepening of Data Management in Drug Development" (Japanese only)

Visit to Three Southeast Asian Countries to Host the "15th Asian Pharmaceutical Associations Collaboration Conference (APAC)

Report on the 44th Public Relations Seminar

RMP Presentation Slides (27th Annual Meeting of the Japanese Society for Drug Informatics)" is posted.

Issuance of Joint Statement "Clinical Trial Ecosystem Industry Declaration 2025

Report on "BioJapan 2025" is now available.

The "Guidance for Conformity Surveillance of Reexamination etc. (Ver. 2.1, October 2025)" is posted.

"Report on the Results of the Questionnaire Survey on the Review Status of New Pharmaceuticals and New Biologics at the Pharmaceuticals and Medical Devices Agency -January 2025 Survey-" is available.

Report on Side Events Held during the United Nations Assembly" is posted.

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

Slide "Survey of RMP Case Studies and Preparation of Case Studies" has been added.

The 15th APAC (Asia-Pacific Association of Pharmaceutical Manufacturers and Associations) Conference" is now available.

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

Information on the webinar "Toward the Formation of a Global Community for the Promotion of Antimicrobial Research and Development" is now available.

The "eCTD v4 Preparation Guide Version 1.0" is now available.

A cover letter template has been created for use in the simplified review system in the Asian region.

Awarded third place in the "My CareerStudy Course Contest 2025. JPMA's video course for younger college students received high marks from student judges.

Q&A on Quality and Non-clinical Conformity Written Survey" is posted.

The "Impact on Drug Development after the Introduction of ICH M11" is now available.

Questionnaire Report on the Promotion of eSource Utilization of Electronic Medical Records, etc." is posted.

RMP Training Slides for MRs (revised August 2025)" is available.

Report on JPMA Media Forum "Two Major Issues in Countermeasures against Infectious Diseases: Countermeasures against Drug-Resistant Strains of Bacteria and Proper Understanding of Immunization" is now available.

DX Lecture Slides (58th Annual Meeting of the Pharmaceutical Society of Japan)" is now available.

The report of "The 15th Annual Meeting of the Regulatory Science Society of Japan" is now available.

Dr. Miyabashira, Chairman of the Board, spoke at BioJapan2025 luncheon seminar "Tackling the Challenges of Access to Medicines: Co-creation between the Public and Private Sectors".

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code

Clinical Trials Ecosystem Industry Declaration 2025 on Quality Challenges" is now available.

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

Report on "FY2025 Meeting of Code Administration Managers and Practitioners" is now available.

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

The article "How to Use Simulation in Bayesian Trial Design" is now available.

The "Survey Report on Drugs Designated under the Pioneer Drug Designation System" is now available.

The "Companies that have already introduced the common template for the Explanatory and Consent Documents (ICF)" is now available.

JPMA Code of Practice (Revised May 2025)" Book Issued

The article "Toward the Era of Co-Creation" <16> by Chairperson Tsukahara was published in Nikkan Yakugyo.

Report on "JPMA Media Forum" is now available.

ICH Q3E "Draft Guideline for Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" is now available.

Scientific Discussion on FDA Review Report" was added.

Scientific and Practical Requirements for Drug Candidate Substances Targeted by Companies - Description of Target Product Profile (TPP)" is now available.

The article by Chairperson Okumura on Nikkan Yakugyo was published in the "Toward the Era of Co-Creation" <14>.

The article by Chairperson Nakaji of the Pharmaceutical Evaluation Committee was published in Nikkan Yakugyo.

The article by Kurata, Chairperson of Biopharmaceuticals Committee, is published in Nikkan Yakugyo.

The article "Toward the Age of Co-creation" <12> by Chairperson Misawa was published in Nikkan Yakugyo.

The article by Chairperson of the Consumer Consultation Review Committee, Mr. Wakasugi, was published in Nikkan Yakugyo.

The article of Nikkan Yakugyo interview with Chairperson of Review Board of Ethical Drug Product Information Brochure, Mr. Kondo, was published in Nikkan Yakugyo.

The article by Chairperson Kawashima on Nikkan Yakugyo was published in the "Toward the Era of Co-Creation" <8>.

Chairperson Tada's article on Nikkan Yakugyo's "Toward the Age of Co-Creation" <9> was published.

The report on "The 3rd Japan-Malaysia Symposium on Pharmaceutical Regulation" is now available.

The "3rd Japan-Malaysia Symposium on Drug Regulation" is now available! Hands-on events will be held at the Science Museum. JPMA Kusurium Laboratory 2025 Autumn" where you can learn about drugs in a fun way. SNS campaign for free invitations is also underway!

The article by Chairperson Ouchi of the Code Compliance Promotion Committee was published in the "Nikkan Yakugyo" section of the "Toward the Age of Co-Creation" <7>.

ICH Project Chairperson Mr. Yokota was interviewed by Nikkan Yakugyo.

The article by Chairperson Arima on the Environmental Issues Study Group was published in the "Nikkan Yakugyo" (Daily Yakugyo).

The article "Toward the Era of Co-Creation" <4> by Chairperson Kashitani was published in Nikkan Yakugyo.

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

JPMA members participate in the DIA 2025 Global Annual Meeting and communicate to the world about efforts to address drug lag and loss issues.

The "JPMA KYOKAI Kusuriumu Laboratory 2025 Autumn" Invitation Campaign! is now available.

The article by Chairperson Kumagai on the Optimization of Distribution was published in the "Nikkan Yakugyo" (Daily Yakugyo).

The article, "Toward the Era of Co-Creation <1>," by Chairperson Iwashita of the Industrial Policy Committee, was published.

Manga Guide to the Pharmaceutical Industry "Open! The World of Drugs for the Future" is now available.

Information on "Model Credibility Evaluation in Drug Development" is now available.

Tips for Signal Management Activities in Japan" is now available.

Survey Results on Preparation and Sharing of Clinical Trial Results" is available.

The "Guidelines for FY2012 Open Call for Researcher Support and Subsidies" is now available.

Transparency Guideline for the Relationship between Corporate Activities and Patient Groups" has been updated.

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" for the payment of FY2024 has been updated.

Reporting Form for Pharmacovigilance Regulation Survey" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

DX Presentation Slides (16th Annual Meeting of the Japanese Association of Pharmaceutical Medicine)" is now available.

Report on "The 6th Japan-Korea Symposium on Pharmaceutical Regulation" is available.

Lecture "Clinical Trial 119" is now available.

JPMA sponsors the Sendenkaigi Award in the category of junior high and high school students - Creating the future of life together with the young generation who will be responsible for the future.

Workshop "Smooth Electronic Data Submission and Effective Utilization of CDISC-compliant Data": Report on the Results of Questionnaire on "Inquiries on Electronic Data Submission" and "Handling of Deviation Information and Case Acceptance/Rejection"" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Orientation of the Proposals for the SendenKaigi Award for Junior and Senior High School Students" is now available.

Research report on the drug-resistant bacteria issue was compiled.

Drug Resistance (AMR) Issues at the Forefront - Two doctors involved in cancer treatment talk about the current situation and challenges -" is now available.

Newly added "Examples of Utilization of RMP/RMP Materials - Mainly for Dispensing Pharmacies" is now available.

ICH M4Q(R2) "Guideline Workshops on CTD-Quality Documentation Procedure (Draft)" is now available.

Adopted as a "Model Project for Promoting Decarbonization throughout the Entire Value Chain" by the Ministry of the Environment - 12 companies to participate in formulating common rules for calculating CO2 emissions in the pharmaceutical industry

Guidance for Efficient Preparation of Pharmaceutical Documentation (CSR and CTD (Clinical Tables)) in Response to Environmental Changes" is now available.

JPMA requests the government to strengthen support for unapproved drugs" is now available.

Slide "Current Status and Issues of Post-Marketing Surveillance in Japan - GPSP Questionnaire Survey" (July 5, 2025, 27th Annual Meeting of the Japanese Society for Drug Information)" is posted.

DX Lecture Slides (27th Annual Meeting of the Japanese Society for Drug Information)" is available.

ICH E21 "Inclusion of Pregnant and Lactating Women in Clinical Trials (Draft)" Information Session" is now available.

The following pages are released / updated: "Drug Use Surveillance for Patients Awareness Leaflet" (Japanese)

RMP Follow-up Survey (1st Interim Results)" is available.

Guidance for Reporting of Drug Failure for Drug Combination Products (2025 Edition)" is updated.

English version of "Non-clinical Checklist and Q&A" is now available.

Evaluation of Validation Necessary to Use Digital Biomarkers as Primary Endpoints in Clinical Trials" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Meeting with Pharmaceuticals and Medical Devices Agency (PMDA), National Cancer Center (NCC), and National Institute of Health Risk Management (JIHS)" was held to improve the clinical trial environment in Asia.

Covariate Adjustment in Randomized Controlled Trials Based on FDA Guidance" is now available.

WHA78 Side Event in Geneva "Strengthening Strategic Partnerships to Combat Infectious Diseases (Vector-Borne Diseases, Neglected Tropical Diseases, and Emerging Infectious Diseases)" is now available.

The report of "ICH Madrid Meeting" is available.

The 51st ICH Public Meeting" is now available.

Report on the 14th APAC (Asian Pharmaceutical Association Conference)

Dawn of the ICH E6(R3) Era: The Future of Clinical Data Manager" is now available.

Information on "Patient Experience Information Useful for Decision-Making in Drug Development" (June 13, 2025) is now available.

Workshop on "R" on April 2, 2025" is now available.

Report on "FY2025 Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee" is now available.

A "Guide for Medical Writers to Prepare Regulatory Documentation in Response to Changes in the Digital Technology Environment, including Generation AI" is now available.

Comparison of Guidance on the Use of RWD/RWE in Japan and the U.S." is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Updated "Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)".

Guideline Workshops on ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" (Step 2 document)" is now available.

Dr. Kinoshita participated in a panel organized by "Endpoints News" in the U.S.

The "Issues and Priorities Roundtable Report on RWD/RWE Utilization" has been updated.

JPMA Code of Practice Revision

The "Digital Therapeutics in Japan (DTx): Current Status and Challenges" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

The following pages are released / updated: "Reference: Creating a society where clinical trials are accessible to all.

Reference Manual for Clinical Development of Regenerative Medicine Products" is now available.

Q&A on ICF Common Template" is now available.

Handbook on Regulatory Requirements and Issuances of Electronic Information, 5th Edition" is now available.

The article "Utilization of Patient Experience Information for Patient-Focused Drug Development - For Decision-Making Based on Patients' Opinions" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Report on "FY2024 Workshop for Product Information Overview Managers and Practitioners" is now available.

The 14th Asian Pharmaceutical Association Conference (APAC) Press Conference held on April 23" is now available.

Video content "Messages from seniors to pharmacy students who aspire to become pharmacists" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

The video "Model Credibility Assessment in Drug Development" is now available.

Report on "JPMA Media Forum" is now available.

Report on "FY2024 Meeting of Compliance Managers and Practitioners" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Patient Reported Outcomes in Clinical Trials: A Guide to Using PROs for Clinical Development Professionals" has been re-published.

The "Future Drug Researchers are Born! The JPMA's "Kusurium Laboratory," a popular hands-on event, was held.

Public Call for Researchers Support and Grants "FY2024 Adoption Result" is now available.

Event for medical institutions "Symposium for Promotion of ICF Common Template Utilization: Case Studies of Introduction at Medical Institutions" (Web-based event: Feb. 26, 2025) is now available.

Notice of Revision of the Common Template Document for Explanatory and Consent Documents (ICF)" is now available.

The report "Analysis of Application Documents for Regenerative Medicine Product Approval (Life Cycle Management Information)" is updated.

Business Policy, Business Plan, and Implementation Plan" for FY2025 is now available.

Results of questionnaire for domestic implementation of ICH M11 "Electronically Structured and Harmonized Clinical Study Protocol (CeSHarP)" (FY2024) are now available.

#AlwaysInnovating: Pharmaceutical Industry Facts & Figures is now available.

Report on "2025 Life Science Intellectual Property Forum" is now available.

The "FY2024 Assembly of the Clinical Evaluation Subcommittee Part 2: Presentation Materials" is posted.

ICH M13B "Bioequivalence of Immediate Release Oral Solid Dosage Forms - Additional Content Biowaiver" Guideline Workshops" is posted.

ICH M15 "Draft General Principles for Model-Informed Drug Development" Information Meeting" is now available.

Briefing on "Alliance for Research in Southeast and East Asia (ARISE)" on April 2, 2025.

The "Guide to the Preparation of Periodic Reporting of Infectious Diseases (2025 Revised Edition)" is now available.

Report on "CMC Strategy Forum Japan 2024" is now available.

Presentation materials for "Symposium on eCTD v4 Implementation Promotion" held in November 2024 are now available.

How to proceed with the study of post-marketing database survey using a registry" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

The "Asian Trial Network for Adolescent and Translational Oncology Study (ATLAS project) Information Meeting" held on February 25, 2025 is now available.

The Second Neglected Tropical Diseases Contest" is now available.

Information on the value of various pharmaceutical products" is now available.

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" is updated.

JPMA Rare Disease Day 2025 Symposium Report" is now available.

Report on the Actual Situation Concerning Publication in MA" is now available.

Toward the Utilization of Structured Data for Clinical Trial Notification" is now available.

JPMA Rare Disease Day 2026 Symposium" Report Video and Report are now available.

Checklist for Voluntary Quality Tests_ver.1" is now available.

Presentation Material for Asian eCTD / Gateway System Information Symposium" is now available.

Notes on TMF Data Migration" is now available.

Q&A on Application for Authorized Users of the Next Generation Medical Infrastructure Act" is now available.

Briefing on Detailed Questionnaire Used for Adverse Reaction Surveillance (JPMA Electronic Model)" is now available.

The English version of the report "Evolution and Advancement of Data Management in Drug Development(Executive Summary)" is now available.

The "Actual Conditions and Challenges of DB Research in MA: A Comprehensive Analysis (FY2025)" is now available.

The article "Toward the Use of Wearable Devices" is now available.

Proposal for holding the "Workshop on the Implementation of the Clinical Trials Ecosystem Industry Declaration 2025"" is now available.

Information and background necessary for companies to utilize disease registries" is now available.

Survey on Communication Issues at the Time of DCT Introduction" is now available.

2025 Assembly of the Clinical Evaluation Subcommittee, Part 1: Presentation Materials" is posted.

Report on Results of Questionnaire Survey on Companies' Current Perceptions of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency (February 2026)" is posted.

The symposium "Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials" is now available for viewing in advance.

The "Impact of the "Study Group on Regulation of Pharmaceutical Affairs to Enhance Drug Discovery and Ensure Stable Supplies of Drugs" related notifications as revealed through the results of a survey conducted in the pharmaceutical industry" is now available.

Report on "CMC Strategy Forum Japan 2025" is now available.

The following pages are released: "Hands-on Workshop for Utilization of Medical Information Databases in PV Activities: Video Lecture by Dr. Chieko Ishiguro" (Japanese).

The Third Annual Neglected Tropical Diseases Contest is Held

Information on "Symposium on Pediatric Drug Development on March 17, 2026" is now available.

JPMA and AMED "Joint Press Conference" Report is now available.

QMS in PV" is now available.

Report on "ICH Singapore Meeting" is now available.

Mapping of Clinical Trial Documents in TMF Reference Model (Revised Version)" is available.

The 148th Assembly of the Drug Evaluation Committee" is posted.

Asian eCTD / Gateway System Information" was added.

Report on "The 52nd GMP Case Study Workshop in 2025" is now available.

Results of Questionnaire on Information Provision Activities at the Time of Precautionary Statements Revision" is posted.

The following pages are released: "A Review of the First 10 Years since the Introduction of the RMP System from the Pharmaceutical Industry's Perspective" (Japanese only)

Slides for eCTD v4 Implementation Promotion Symposium (JPMA Presentation)" is available.

DX Lecture Slides (19th Annual Assembly of the Japanese Society of Pharmacy)" is available.

Preliminary Study on Application of AI to Quality Management of Clinical Trials" is posted.

R & D Committee Member Companies' R&D Needs" has been updated.

The following pages are released: "Data Linkage Concept: Data Linkage from the Perspective of Overseas Regulations" (Japanese)

The "Guide to Conducting Post-Marketing Database Surveillance - November 2025 Edition" is now available.

The following pages are released / updated: "Evolution and Deepening of Data Management in Drug Development" (Japanese only)

RMP Presentation Slides (27th Annual Meeting of the Japanese Society for Drug Informatics)" is posted.

Issuance of Joint Statement "Clinical Trial Ecosystem Industry Declaration 2025

Report on "BioJapan 2025" is now available.

The "Guidance for Conformity Surveillance of Reexamination etc. (Ver. 2.1, October 2025)" is posted.

"Report on the Results of the Questionnaire Survey on the Review Status of New Pharmaceuticals and New Biologics at the Pharmaceuticals and Medical Devices Agency -January 2025 Survey-" is available.

Slide "Survey of RMP Case Studies and Preparation of Case Studies" has been added.

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

The "eCTD v4 Preparation Guide Version 1.0" is now available.

Q&A on Quality and Non-clinical Conformity Written Survey" is posted.

The "Impact on Drug Development after the Introduction of ICH M11" is now available.

Questionnaire Report on the Promotion of eSource Utilization of Electronic Medical Records, etc." is posted.

RMP Training Slides for MRs (revised August 2025)" is available.

DX Lecture Slides (58th Annual Meeting of the Pharmaceutical Society of Japan)" is now available.

The report of "The 15th Annual Meeting of the Regulatory Science Society of Japan" is now available.

Clinical Trials Ecosystem Industry Declaration 2025 on Quality Challenges" is now available.

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

The article "How to Use Simulation in Bayesian Trial Design" is now available.

The "Survey Report on Drugs Designated under the Pioneer Drug Designation System" is now available.

The "Companies that have already introduced the common template for the Explanatory and Consent Documents (ICF)" is now available.

The article "Toward the Era of Co-Creation" <16> by Chairperson Tsukahara was published in Nikkan Yakugyo.

Report on "JPMA Media Forum" is now available.

ICH Q3E "Draft Guideline for Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" is now available.

Scientific Discussion on FDA Review Report" was added.

Scientific and Practical Requirements for Drug Candidate Substances Targeted by Companies - Description of Target Product Profile (TPP)" is now available.

The article by Chairperson Okumura on Nikkan Yakugyo was published in the "Toward the Era of Co-Creation" <14>.

The article by Chairperson Nakaji of the Pharmaceutical Evaluation Committee was published in Nikkan Yakugyo.

The article by Kurata, Chairperson of Biopharmaceuticals Committee, is published in Nikkan Yakugyo.

The article by Chairperson Kawashima on Nikkan Yakugyo was published in the "Toward the Era of Co-Creation" <8>.

ICH Project Chairperson Mr. Yokota was interviewed by Nikkan Yakugyo.

The article "Toward the Era of Co-Creation" <4> by Chairperson Kashitani was published in Nikkan Yakugyo.

The article, "Toward the Era of Co-Creation <1>," by Chairperson Iwashita of the Industrial Policy Committee, was published.

Information on "Model Credibility Evaluation in Drug Development" is now available.

Tips for Signal Management Activities in Japan" is now available.

Survey Results on Preparation and Sharing of Clinical Trial Results" is available.

Reporting Form for Pharmacovigilance Regulation Survey" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

DX Presentation Slides (16th Annual Meeting of the Japanese Association of Pharmaceutical Medicine)" is now available.

Lecture "Clinical Trial 119" is now available.

Workshop "Smooth Electronic Data Submission and Effective Utilization of CDISC-compliant Data": Report on the Results of Questionnaire on "Inquiries on Electronic Data Submission" and "Handling of Deviation Information and Case Acceptance/Rejection"" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Newly added "Examples of Utilization of RMP/RMP Materials - Mainly for Dispensing Pharmacies" is now available.

ICH M4Q(R2) "Guideline Workshops on CTD-Quality Documentation Procedure (Draft)" is now available.

Guidance for Efficient Preparation of Pharmaceutical Documentation (CSR and CTD (Clinical Tables)) in Response to Environmental Changes" is now available.

Slide "Current Status and Issues of Post-Marketing Surveillance in Japan - GPSP Questionnaire Survey" (July 5, 2025, 27th Annual Meeting of the Japanese Society for Drug Information)" is posted.

DX Lecture Slides (27th Annual Meeting of the Japanese Society for Drug Information)" is available.

ICH E21 "Inclusion of Pregnant and Lactating Women in Clinical Trials (Draft)" Information Session" is now available.

The following pages are released / updated: "Drug Use Surveillance for Patients Awareness Leaflet" (Japanese)

RMP Follow-up Survey (1st Interim Results)" is available.

Guidance for Reporting of Drug Failure for Drug Combination Products (2025 Edition)" is updated.

English version of "Non-clinical Checklist and Q&A" is now available.

Evaluation of Validation Necessary to Use Digital Biomarkers as Primary Endpoints in Clinical Trials" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Covariate Adjustment in Randomized Controlled Trials Based on FDA Guidance" is now available.

The report of "ICH Madrid Meeting" is available.

The 51st ICH Public Meeting" is now available.

Dawn of the ICH E6(R3) Era: The Future of Clinical Data Manager" is now available.

Information on "Patient Experience Information Useful for Decision-Making in Drug Development" (June 13, 2025) is now available.

Workshop on "R" on April 2, 2025" is now available.

Report on "FY2025 Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee" is now available.

A "Guide for Medical Writers to Prepare Regulatory Documentation in Response to Changes in the Digital Technology Environment, including Generation AI" is now available.

Comparison of Guidance on the Use of RWD/RWE in Japan and the U.S." is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Updated "Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)".

Guideline Workshops on ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" (Step 2 document)" is now available.

The "Issues and Priorities Roundtable Report on RWD/RWE Utilization" has been updated.

The "Digital Therapeutics in Japan (DTx): Current Status and Challenges" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Reference Manual for Clinical Development of Regenerative Medicine Products" is now available.

Q&A on ICF Common Template" is now available.

Handbook on Regulatory Requirements and Issuances of Electronic Information, 5th Edition" is now available.

The article "Utilization of Patient Experience Information for Patient-Focused Drug Development - For Decision-Making Based on Patients' Opinions" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

The video "Model Credibility Assessment in Drug Development" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Patient Reported Outcomes in Clinical Trials: A Guide to Using PROs for Clinical Development Professionals" has been re-published.

Event for medical institutions "Symposium for Promotion of ICF Common Template Utilization: Case Studies of Introduction at Medical Institutions" (Web-based event: Feb. 26, 2025) is now available.

Notice of Revision of the Common Template Document for Explanatory and Consent Documents (ICF)" is now available.

The report "Analysis of Application Documents for Regenerative Medicine Product Approval (Life Cycle Management Information)" is updated.

Results of questionnaire for domestic implementation of ICH M11 "Electronically Structured and Harmonized Clinical Study Protocol (CeSHarP)" (FY2024) are now available.

Report on "2025 Life Science Intellectual Property Forum" is now available.

The "FY2024 Assembly of the Clinical Evaluation Subcommittee Part 2: Presentation Materials" is posted.

ICH M13B "Bioequivalence of Immediate Release Oral Solid Dosage Forms - Additional Content Biowaiver" Guideline Workshops" is posted.

ICH M15 "Draft General Principles for Model-Informed Drug Development" Information Meeting" is now available.

Briefing on "Alliance for Research in Southeast and East Asia (ARISE)" on April 2, 2025.

The "Guide to the Preparation of Periodic Reporting of Infectious Diseases (2025 Revised Edition)" is now available.

Report on "CMC Strategy Forum Japan 2024" is now available.

Presentation materials for "Symposium on eCTD v4 Implementation Promotion" held in November 2024 are now available.

How to proceed with the study of post-marketing database survey using a registry" is now available.

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

The "Asian Trial Network for Adolescent and Translational Oncology Study (ATLAS project) Information Meeting" held on February 25, 2025 is now available.

JPMA Rare Disease Day 2025 Symposium Report" is now available.

JPMA Rare Disease Day 2026 Symposium" Report Video and Report are now available.

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

Report on "The 5th Japan-Vietnam Joint Symposium" is now available.

Pathways from Development to Access to Innovation (IDAP)" is now available.

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

Report on "The 5th Seminar on Economic Security" is posted.

Special Session at the "12th Nikkei-FT Conference on Infectious Diseases

Visit to Three Southeast Asian Countries to Host the "15th Asian Pharmaceutical Associations Collaboration Conference (APAC)

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

The 15th APAC (Asia-Pacific Association of Pharmaceutical Manufacturers and Associations) Conference" is now available.

Information on the webinar "Toward the Formation of a Global Community for the Promotion of Antimicrobial Research and Development" is now available.

A cover letter template has been created for use in the simplified review system in the Asian region.

Report on JPMA Media Forum "Two Major Issues in Countermeasures against Infectious Diseases: Countermeasures against Drug-Resistant Strains of Bacteria and Proper Understanding of Immunization" is now available.

Dr. Miyabashira, Chairman of the Board, spoke at BioJapan2025 luncheon seminar "Tackling the Challenges of Access to Medicines: Co-creation between the Public and Private Sectors".

The report on "The 3rd Japan-Malaysia Symposium on Pharmaceutical Regulation" is now available.

JPMA members participate in the DIA 2025 Global Annual Meeting and communicate to the world about efforts to address drug lag and loss issues.

The article by Chairperson Kumagai on the Optimization of Distribution was published in the "Nikkan Yakugyo" (Daily Yakugyo).

The article, "Toward the Era of Co-Creation <1>," by Chairperson Iwashita of the Industrial Policy Committee, was published.

Report on "The 6th Japan-Korea Symposium on Pharmaceutical Regulation" is available.

Research report on the drug-resistant bacteria issue was compiled.

Drug Resistance (AMR) Issues at the Forefront - Two doctors involved in cancer treatment talk about the current situation and challenges -" is now available.

JPMA requests the government to strengthen support for unapproved drugs" is now available.

Meeting with Pharmaceuticals and Medical Devices Agency (PMDA), National Cancer Center (NCC), and National Institute of Health Risk Management (JIHS)" was held to improve the clinical trial environment in Asia.

Report on the 14th APAC (Asian Pharmaceutical Association Conference)

Dr. Kinoshita participated in a panel organized by "Endpoints News" in the U.S.

The 14th Asian Pharmaceutical Association Conference (APAC) Press Conference held on April 23" is now available.

Report on "JPMA Media Forum" is now available.

Information on the value of various pharmaceutical products" is now available.

JPMA Rare Disease Day 2025 Symposium Report" is now available.

Revision of Transparency Guideline for the Relation between Corporate Activities and Medical Institutions

Open Call for Researchers Support and Grants "FY2025 Adoption Results" is now available.

JPMA Rare Disease Day 2026 Symposium" Report Video and Report are now available.

The industry's first Scope 3 guidelines were released at the "Ministry of the Environment Model Project Outcome Debriefing Session.

The following pages are released: "[Interview with a Patient Organization] Small Questions Create the Future: Opening the Door to Participation and Collaboration - Support familia Yamaguchi for Intractable Diseases" (Japanese only).

Proposal on Intractable and Rare Diseases Based on the Survey of Healthcare Professionals' Concerns

Implementation of the webinar "Toward the Formation of a Global Community to Promote Research and Development of Antimicrobial Agents" was featured on the INCATE website.

First Report on the Judging of the Senden Kaigi Award in the Junior High and High School Student Category

JPMA Q&A on the Clinical Research Act and Enforcement Regulations of the Clinical Research Act" is now available.

Report on the 44th Public Relations Seminar

Report on Side Events Held during the United Nations Assembly" is posted.

Awarded third place in the "My CareerStudy Course Contest 2025. JPMA's video course for younger college students received high marks from student judges.

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code

Report on "FY2025 Meeting of Code Administration Managers and Practitioners" is now available.

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

JPMA Code of Practice (Revised May 2025)" Book Issued

The article "Toward the Age of Co-creation" <12> by Chairperson Misawa was published in Nikkan Yakugyo.

The article by Chairperson of the Consumer Consultation Review Committee, Mr. Wakasugi, was published in Nikkan Yakugyo.

The article of Nikkan Yakugyo interview with Chairperson of Review Board of Ethical Drug Product Information Brochure, Mr. Kondo, was published in Nikkan Yakugyo.

Chairperson Tada's article on Nikkan Yakugyo's "Toward the Age of Co-Creation" <9> was published.

The "3rd Japan-Malaysia Symposium on Drug Regulation" is now available! Hands-on events will be held at the Science Museum. JPMA Kusurium Laboratory 2025 Autumn" where you can learn about drugs in a fun way. SNS campaign for free invitations is also underway!

The article by Chairperson Ouchi of the Code Compliance Promotion Committee was published in the "Nikkan Yakugyo" section of the "Toward the Age of Co-Creation" <7>.

The article by Chairperson Arima on the Environmental Issues Study Group was published in the "Nikkan Yakugyo" (Daily Yakugyo).

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

The "JPMA KYOKAI Kusuriumu Laboratory 2025 Autumn" Invitation Campaign! is now available.

Manga Guide to the Pharmaceutical Industry "Open! The World of Drugs for the Future" is now available.

The "Guidelines for FY2012 Open Call for Researcher Support and Subsidies" is now available.

Transparency Guideline for the Relationship between Corporate Activities and Patient Groups" has been updated.

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" for the payment of FY2024 has been updated.

JPMA sponsors the Sendenkaigi Award in the category of junior high and high school students - Creating the future of life together with the young generation who will be responsible for the future.

Orientation of the Proposals for the SendenKaigi Award for Junior and Senior High School Students" is now available.

Adopted as a "Model Project for Promoting Decarbonization throughout the Entire Value Chain" by the Ministry of the Environment - 12 companies to participate in formulating common rules for calculating CO2 emissions in the pharmaceutical industry

WHA78 Side Event in Geneva "Strengthening Strategic Partnerships to Combat Infectious Diseases (Vector-Borne Diseases, Neglected Tropical Diseases, and Emerging Infectious Diseases)" is now available.

JPMA Code of Practice Revision

The following pages are released / updated: "Reference: Creating a society where clinical trials are accessible to all.

Report on "FY2024 Workshop for Product Information Overview Managers and Practitioners" is now available.

Video content "Messages from seniors to pharmacy students who aspire to become pharmacists" is now available.

Report on "JPMA Media Forum" is now available.

Report on "FY2024 Meeting of Compliance Managers and Practitioners" is now available.

The "Future Drug Researchers are Born! The JPMA's "Kusurium Laboratory," a popular hands-on event, was held.

Public Call for Researchers Support and Grants "FY2024 Adoption Result" is now available.

Business Policy, Business Plan, and Implementation Plan" for FY2025 is now available.

#AlwaysInnovating: Pharmaceutical Industry Facts & Figures is now available.

The Second Neglected Tropical Diseases Contest" is now available.

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" is updated.

JPMA Rare Disease Day 2025 Symposium Report" is now available.