Drug Evaluation Committee All Deliverables of the Drug Evaluation Committee
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(New arrivals first)
- Guide to Creating Terms of Use for Adverse Event Database (ADB) Tools (June 2026)
- Theory and Practice of Model-Based Meta-Analysis in Drug Development (May 2026)
- Explanation of “Handling of Information Provision Regarding Clinical Trials, etc.” and Q&A (May 2026)
- Current Status of Post-Marketing Surveys Under Japan’s GPSP Ordinance: A Survey on GPSP (May 2026)
- Survey and Analysis of Regulations and Current Practices Regarding Clinical Trials Not Dependent on Visits to Medical Institutions (May 2026)
- Digital Technology in Preventive Medicine and Initiatives by Pharmaceutical Companies (May 2026)
- ICH-E6 (R3) Awareness Video (May 2026)
- Survey and Analysis on Data Utilization in jRCTs and Clinical Trial Notifications in Preparation for ICH M11 Implementation (May 2026)
- The Dawn of the ICH E6(R3) Era: The Future of the Clinical Data Manager—How Will the Role of the Clinical Data Manager Change Through the Identification of CTQ Factors? (May 2026)
- What Constitutes Effective Communication of Pharmaceutical Information That Builds Trust? — Toward Building “Trust” and “Conviction” Based on Scientific Evidence (April 2026)
- “People × Technology × Future: The Next Generation of Pharmacovigilance as We Envision It” Workshop Held (April 2026)
- Guidance on Preparing “Infectious Disease Evaluation Reports” (2026 Edition) (April 2026)
- Positioning Map Analysis of Patients’ Online Searches for Drug Information (April 2026)
- A Beginner’s Guide to Using the NDB in Pharmaceutical Companies (April 2026)
- Results of a Survey for Pharmaceutical Companies on Post-Marketing Surveillance (April 2026)
- Common Template for Informed Consent Forms (ICF) (April 2026)
- Standard Operating Procedures, etc., Concerning the Electronic Handling of Clinical Trial-Related Documents (2024 Edition) (April 2026)
- “Don’t Take Medical and Health Information at Face Value!” Awareness Materials (Joint Initiative by 3 Organizations) (April 2026)
- Handbook on Regulatory Requirements and Submissions for Digitized Information (April 2026)
- The Contribution of Clinical Pharmacology to Ensuring Diversity in Drug Development —Toward Bridging the Gap in Patient Characteristics Between Real-World Practice and Clinical Trials— (April 2026)
- Considerations Regarding Computerized System Validation When a Sponsor Builds a DCT System Using the eConsent System as a Case Study (April 2026)
- Overview of the FDA’s Proposed Framework for “Risk-Based Credibility Assessment of AI Models” (April 2026)
- Results of a Longitudinal Survey on Patient and Citizen Engagement Activities in Pharmaceutical Companies’ Drug Development (March 2026)
- Systematic Survey on RWD/RWE – FDA Approval Application Cases and Approaches to Challenges Using Innovative Technologies – (April 2026)
- Discussion – Survey to Identify Healthcare Professionals’ Needs Regarding Drug Safety Information (Physicians, Pharmacists) – Conducted in May 2023 (April 2026)
- Guidance on Filing “Electronic Package Inserts for Prescription Drugs” —April 2026 Edition— (April 2026)
- Report on a Survey of Publication Practices in Medical Affairs (March 2026)
- Toward the Utilization of Structured Data in Clinical Trial Notifications (March 2026)
- Self-Inspection Checklist for Quality Testing_ver.1 (March 2026)
- Points to Note During TMF Data Migration (March 2026)
- Q&A Regarding Applications for Certification as a Provider of Anonymized Medical Information under the Next-Generation Medical Infrastructure Act (March 2026)
- Report on the Briefing Session for the Detailed Investigation Form Used in Adverse Event Investigations (JPMA Electronic Model) (March 2026)
- Current Status and Challenges of Database Research in Medical Affairs: A Comprehensive Analysis Based on a Questionnaire Survey and Literature Review (FY 2025 Survey) (March 2026)
- Announcement Regarding the Utilization of Wearable Devices (March 2026)
- Information Required for Companies to Utilize Disease Registries and the Background Thereof (March 2026)
- Announcement of the Release of the Report on Communication Challenges During DCT Implementation: An Approach to Minimize Communication Risks and Maximize the Benefits of DCT (February 2026)
- Impact of Notifications from the “Study Group on the Ideal Form of Pharmaceutical Regulations for Strengthening Drug Discovery Capabilities and Ensuring Stable Supply,” as Revealed by Survey Results from the Pharmaceutical Industry (February 2026)
- “Hands-On Workshop on Utilizing Medical Information Databases in Postmarketing Surveillance (September 2025): Video of Dr. Chieko Ishiguro’s Lecture, ‘Potential Applications of Medical Databases in Routine Safety Surveillance Activities,’ Now Available” (February 2026)
- Survey and Analysis of Clinical Data Packages for Approved Products (April 2026)
- Q&A Regarding the Clinical Research Act, the Enforcement Regulations of the Clinical Research Act, and Related Notifications (January 5, 2026) (January 2026)
- QMS in PV (January 2026)
- Mapping List of Clinical Trial-related Documents, etc. in Japan to the Trial Master File Reference Model Ver. 3.3.1 (December 2025 Revised Version) (January 2026)
- Announcement of the Release of Information on the Asian eCTD / Gateway System (December 2025)
- Survey Results on Information Provision Activities During Revisions to “Precautions for Use”
— Trends Among Companies Following the Revision of the Safety Guidance — (December 2025) - Reflections on the First 10 Years Since the Introduction of the RMP System from the Perspective of the Pharmaceutical Industry (December 2025)
- Announcement Regarding the Release of Presentation Materials from the eCTD v4 Implementation Promotion Symposium (Held Online on November 28, 2025) (December 2025)
- Presentation Slides: “From the Pharmaceutical Industry: ‘How Do We Want You to Use This?’—The Intent Behind Various Materials” (November 1, 2025, 19th Annual Assembly of the Japanese Society of Pharmacy) (December 2025)
- Preliminary Study on the Application of AI to Clinical Trial Quality Management: Aiming to Foster a “Quality Culture” That Embraces AI (December 2025)
- Data Interoperability Initiative: Data Interoperability from the Perspective of Overseas Regulations (Phase 2 Activity Report) (November 2025)
- Guidance on Conducting Post-Marketing Database Surveys - November 2025 Edition - (November 2025)
- Evolution and Advancement of Data Management in Drug Development(Executive Summary) (November 2025)
- Presentation Slides: “Pharmaceutical Industry Initiatives to Promote the Utilization of RMPs and RMP Materials” (July 5, 2025, 27th Annual Assembly and Academic Conference of the Japanese Society for Pharmaceutical Information) (November 2025)
- “Survey of Case Studies on the Utilization of Risk Management Plans (RMPs) and Compilation of a Case Study Collection” November 1, 2025—Presentation Slides at the 19th Annual Assembly of the Japanese Society of Pharmacy Practice (November 2025)
- Announcement of the Release of the eCTD v4 Preparation Guide, Version 1.0 (November 2025)
- Guidance on Re-evaluation and Compliance Surveys (October 2025)
- Q&A on Quality and Nonclinical Compliance Document Reviews (October 2025)
- Impact of ICH M11 Implementation on Drug Development (October 2025)
- Survey Report on Promoting the Use of eSources, Such as Electronic Health Records (October 2025)
- RMP Training Slides for Medical Representatives (Revised in August Reiwa 7) (October 2025)
- Presentation Slides: “Bringing Pharmaceutical Companies’ Vision to Life: The Challenge of Delivering Appropriate Medication Information to Patients” (October 13, 2025, 58th Annual Scientific Conference of the Japan Pharmaceutical Association) (October 2025)
- How to Use Simulation in Bayesian Trial Design (October 2025)
- Investigation Reports on Medicines Designated Under the Pioneering Review Designation System and the Pioneering Drug Designation System (October 2025)
- Scientific Discussions Learned from FDA Review Reports (September 2025)
- Tips for Signal Management Activities in Japan (August 2025)
- Survey Results on the Preparation and Sharing of Clinical Trial Results (August 2025)
- [Published on the JPMA Website] PV: KT5—Pharmacovigilance Regulatory Survey Report Form (August 2025)
- Presentation Slides: “Providing Information on Adverse Drug Reactions: The Future of Information Provision for the Next Generation” (July 25, 2025, 16th Annual Meeting of the Japanese Society for Pharmaceutical Medicine) (August 2025)
- [Published on the JPMA Website] PV: KT1—Collection of Case Studies on the Use of RMPs and RMP Materials—Primarily for Dispensing Pharmacies (July 2025)
- Guidance on the Efficient Preparation of Regulatory Documents (CSR and CTD [Clinical Part]) in Response to Environmental Changes (July 2025)
- Presentation Slides: “Current Status and Challenges of Post-Marketing Surveys in Japan—GPSP Questionnaire Survey” (July 5, 2025, 27th Annual Assembly and Academic Conference of the Japanese Society for Drug Information) (July 2025)
- Presentation Slides: “Delivering the Latest Information Patients Need—From a Pharmaceutical Company’s Perspective” (July 6, 2025, 27th Annual Assembly and Academic Conference of the Japanese Society for Pharmaceutical Information) (July 2025)
- Are You Familiar with the “Post-Marketing Surveillance” Conducted by Pharmaceutical Companies? (July 2025)
- RMP Follow-up Survey on the Implementation Status of Post-Marketing Surveys, etc. (1st Interim Results) (July 2025)
- Guidance on Preparing Adverse Event Reports for Combination Products Classified as Drugs (2025 Edition) (July 2025)
- English Version of the Self-Inspection Checklist and Q&A for Nonclinical Studies (Ver. 1) (July 2025)
- Evaluation of the Validation Required to Use Digital Biomarkers as Primary Endpoints in Clinical Trials (July 2025)
- Covariate Adjustment in Randomized Controlled Trials Based on FDA Guidance (June 2025)
- The Dawn of the ICH E6 (R3) Era: The Future of the Clinical Data Manager—A Summary of Sections Related to CDMs (June 2025)
- A Guide to Regulatory Document Preparation for Medical Writers in Response to Changes in the Digital Technology Environment, Including Generative AI (June 2025)
- Comparison of Guidance on the Utilization of RWD/RWE in Japan and the U.S. (May 2025)
- Report on the Roundtable Discussion: Identifying and Prioritizing Challenges for the Utilization of RWD and RWE (May 2025)
- The Current State and Challenges of Digital Therapeutics (DTx) in Japan
—A Comparison with Systems in Germany and the United States— (May 2025) - Reference Manual on Clinical Development of Regenerative Medicine Products (May 2025)
- Handbook on Regulatory Requirements and Deliverables for Digitized Information (May 2025)
- Utilizing Patient Experience Data for Patient-Focused Drug Development
—For Decision-Making Based on Patients’ Voices— (April 2025) - Model Credibility Assessment in Pharmaceutical Development (April 2025)
- Patient-Reported Outcomes in Clinical Trials: A Guide to Using PROs for Clinical Development Professionals (Reprinted April 2025)
- Survey Results on the Domestic Implementation of ICH M11 “Electronically Structured and Harmonized Clinical Trial Protocol (CeSHarP)” (FY 2024) (March 2025)
- Guide to Preparing “Periodic Reports on Infectious Diseases” (2025 Revised Edition) (March 2025)
- Brochure: What Are Medical Affairs (MA) in Pharmaceutical Companies? (March 2025)
- How to Proceed with Post-Marketing Database Studies Using Registries - February 2025 Edition - (March 2025)
- Considerations on Simulation for Planning Adaptive Designs (February 2025)
- Points to Consider When Conducting Indirect Comparisons in Cost-Effectiveness Analyses (February 2025)
- Easy to Understand! A Guide to Viewing the PMDA Video on “Surveys on Compliance with Re-evaluation Requirements” (February 2025)
- Handling Missing Data in Clinical Trials (February 2025)
- Guidance on Preparing a Pharmaceutical Risk Management Plan (J-RMP) – January Reiwa 7 Edition – (January 2025)
- Utilization of Real-World Data in Cost-Effectiveness Analysis—Lessons Learned from the NICE Real-World Evidence Framework and the Current Status of Real-World Data Utilization in Japan— (January 2025)
- FY2024 OSS Usage Survey Report (January 2025)
- Considerations on Pseudonymization Techniques When Creating Pseudonymized Information, etc. (December 2024)
- RMP Overview (Including the Latest Information on Medical Fee Schedule Revisions, etc.) November 3, 2024: Presentation Slides from the Japanese Society of Medical Pharmacology (December 2024)
- Translation: FDA Guidance on Real-World Data (RWD) (November 2024)
- Points to Note When Conducting Trials Applying ICH E19 “Selective Approaches to Safety Data Collection in Specific Clinical Trials Conducted During Late-Stage Development or Post-Approval” — Primarily from a Data Management Perspective — (November 2024)
- Announcement of the Release of the 2nd Edition of eCTD v4.0 Training Materials (November 2024)
- Checklist for Transparency in the Sharing of De-identified/Anonymized Data —Based on the Checklist Developed by TransCelerate— (November 2024)
- Guidance on Procedures for the Waiver of Post-Marketing Approval Conditions / Explanation of “Q&A Regarding Post-Marketing Surveillance of Prescription Drugs Using the All-Case Survey Method” (October 2024)
- Survey Results on the Adoption Status of DCT and Various DCT Methods (October 2024)
- An Approach to QMS Implementation for Clinical Trial Sponsors: Fostering a Culture of Quality and Exercising Leadership (September 2024)
- How to Find Clinical Trials: A Guide to jRCT—3rd Edition (April 2025)
- Survey on Patients’ and Their Families’ Access to Drug Information – Preliminary Report – (Conducted in February 2024) (July 2024)
- Overview of the FDA’s Draft CSA Guidance and Considerations for Its Application to the GxP Domain (July 2024)
- Overview and Key Points of the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects (July 2024)
- Survey Report to Assess the Current Status of Post-Marketing Database Surveys (Feasibility Studies/Reliability Verification) (July 2024)
- Prototyping a Model for Evaluating the Use of AI in Data Management Operations (June 2024)
- Explanation of the RMP Mark (Revised in 2024) (June 2024)
- Challenges and Root Cause Analysis in Health Communication Between Patients/Citizens and Pharmaceutical Companies (June 2024)
- Causal Inference for Interpretation: Causal Mediation Analysis (June 2024)
- To Pharmaceutical Companies Creating Documents for Non-Experts: Communicating Clinical Trial Information Clearly (June 2024)
- Challenges in Regulatory Documentation and Proposals for the Use of Digital Technology Toward Society 5.0 (Data Society) (June 2024)
- Meeting to Discuss the Smooth Implementation of Electronic Data Submission for Applications: “Results of the Questionnaire on Consultations Regarding Exemptions from Electronic Data Submission” and “Information Sharing on SDTMIG v3.3 and Define-XML v2.1” (June 2024)
- Case Studies on the Use of Open-Source Software (June 2024)
- Utilization of the Medical Information Database (June 2024)
- Recommendations on the Collection and Reporting of Safety Data (May 2024)
- Promoting Consistent Quality Management in Clinical Trials (May 2024)
- Overview of Software as a Medical Device (SaMD) Development (May 2024)
- Current Status and Potential of Digital Transformation (DX) in Clinical Development (May 2024)
- Guidance on “Periodic Safety Reports” – Using the Gateway System – (May 2024)
- Expectations for Policies and Other Measures to Promote the Secondary Use of Real-World Data in Drug Development (May 2024)
- Clinical Pharmacological Evaluation in the Development of New Modalities—Current Status, Challenges, and Future Prospects— (May 2024)
- Current Status and Case Studies of Complex Innovative Trial Designs—Including a Japanese Translation of the FDA Guidance (April 2024)
- Report on the Results of a Survey Regarding Patient Participation in Clinical Trials (April 2024)
- Efficient Preparation of CSV Documents Using Vendor Materials (April 2024)
- Training Materials for the E2B(R3) Explanation (April 2024)
- Introduction to Single Sign-On (SSO) for Managing Accounts in Clinical Trial-Related IT Systems (April 2024)
- Standard Operating Procedures, etc., Concerning the Electronic Handling of Clinical Trial-Related Documents (2024 Edition) (April 2024)
- Regarding the Common Master (Healthcare Facility-Related Information) with a View to Utilizing Clinical Trial-Related Systems (April 2024)
- Guidance on Remote Surveys (Re-evaluation) Ver. 3.0 (Prepared in March 2024) (April 2024)
- Glossary of Health and Medical Data Terms (April 2024)
- Guidance on the Preparation of “Electronic Package Inserts for Prescription Drugs” (Revised April 2024) (April 2024)
- Guide to Re-examination Applications: Using the Gateway System (March 2024)
- Guidance on Preparing the “Post-Marketing Surveillance Implementation Plan” and “Post-Marketing Surveillance Implementation Report” (2024 Revised Edition) (March 2024)
- Q&A, 4th Edition, Regarding “Registration of Clinical Trial Implementation Status, etc.” (Pharmaceutical and Medical Devices Safety and Evaluation Division Notice No. 0831-9, August 31, Reiwa 2) (February 2024)
- Guide to Providing Information on “Electronic Package Inserts for Prescription Drugs” (February 2024 Edition)
(February 2024) - Electronic Detailed Investigation Form for Adverse Event Investigations (JPMA Electronic Model) (February 2024)
- “How to Find Clinical Trials: A Guide to jRCT” Awareness Materials (April 2025)
- Survey Results on Electronic Information Provision—Trends Among JPMA Member Companies—(Conducted in January 2023) (January 2024)
- Guidance on Conducting Post-Marketing Database Surveys - January 2024 Edition - (January 2024)
- Report on the Current State and Ideal Approach to Database Research in Medical Affairs (January 2024)
- Guidance on Compliance Surveys for Re-examination, etc. (December 2023)
- Quality Control: Preventing Fraud Before It Occurs (December 2023)
- Introduction to “Collection and Management of Safety Data in Clinical Trials” — From Chapter 4 of the CIOMS Working Group VI Report (December 2023)
- Quality Management in Drug Development: A Review of Risk Communication Practices (December 2023)
- Challenges and Current Status of Bioequivalence Assessment for Drugs with Significant Intra-Individual Variability (December 2023)
- Survey on Healthcare Professionals’ Needs Regarding Drug Safety Information (Physicians, Pharmacists) – Preliminary Report – Conducted in May 2023 (December 2023)
- Pharmaceutical Risk Management Plan (RMP): Comparative Survey of Japan, the U.S., and Europe Regarding the Status of Formulation of Additional Risk Minimization Activities (November 2023)
- Survey Results on the Provision of Patient Information Using Digital Technologies (Companies Participating in the PV Subcommittee; Conducted January–February 2023) (October 2023)
- List of Registration Items for Trials Migrating from JapicCTI, First Edition
jRCT-JapicCTI Registration Item Comparison Table, Second Edition (October 2023) - Survey on the Current State of Model-Informed Drug Development Based on Domestic Approved Products (October 2023)
- Data Integration Concept: Proposals from the Front Lines of Healthcare and Clinical Trials (August 2023)
- Paper on eConsent Implementation and Strategies for Addressing Challenges (August 2023)
- Points to Note Regarding Regulatory Amendments on the Handling of Safety Information for Investigational Medicinal Products in Clinical Trials (August 2023)
- CTD Structure Using the Results of Multi-Regional Clinical Trials Based on the Principles in ICH E17 (December 2023)
- Guidance on Filing “Electronic Package Inserts for Prescription Drugs” (August 2023 Edition) (August 2023)
- Ensuring Effective and Efficient Clinical Trial Quality Based on the “Quality by Design” Philosophy—Aiming for Consistent Quality Management from Planning to Implementation— (July 2023)
- Q&A on the Self-Inspection Checklist for Nonclinical Studies (Ver. 1) (July 2023)
- Flexible Methods for Survival Time Modeling and Methods for Survival Time Extrapolation Using External Information (June 2023)
- Recent Designs of Phase I Cancer Trials and Their Selection (June 2023)
- Challenges and Prospects for Standardizing Medical Information Based on HL7 FHIR and Conducting Efficient Clinical Trials Through Data Integration with Electronic Medical Records (EMRs), Electronic Data Capture (EDC), and Other Systems (June 2023)
- Survey and Analysis of the Current State of Digital Health in Pharmaceutical Companies (June 2023)
- The Future Role and Skill Set of the Clinical Data Manager
~Focusing on Vendor Oversight, QMS, and DCT~ (May 2023) - Utilizing Artificial Intelligence in Data Management: Getting Started with AI (May 2023)
- Multivariate Meta-Analysis and Alternative Endpoints in Health Technology Assessment (May 2023)
- Translation: Data Quality Framework for EU Pharmaceutical Regulations (May 2023)
- “RMP Training Slides for MRs” and “Summary Version: Slides for MRs to Explain the RMP (Slide Template for Explaining the RMP to Healthcare Institutions)” (May 2023)
- Q&A on “Points to Note Regarding Personal Information Protection in Drug Development and Secondary Use of Data” (April 2023)
- “Utilization of Open-Source Software and Points to Note” and “OSS Usage Survey Report” (April 2023)
- Health and Medical Data and Our Daily Lives (April 2023)
- Self-Inspection Checklist for Nonclinical Studies_ver.1 (March 2023)
- Implementation of Estimand in Clinical Trial Protocols (March 2023)
- Key Considerations for Cost-Effectiveness Analysis: Lessons from Case Studies (March 2023)
- eCTD v4.0 Educational Materials (March 2023)
- Basic Principles for Safety Forms in Clinical Trials (February 2023)
- Study on Statistical Inference in Adaptive Designs (February 2023)
- Results of a Survey on the Current Status of Clinical Trials Among Pharmaceutical Companies (January 2023)
- Guidance on Preparing a Pharmaceutical Risk Management Plan (J-RMP) – January Reiwa 5 Edition – (January 2023)
- Internal Process Flow for Utilizing Registries in Drug Approval Applications, etc. (From Internal Proposal to Registry Modification) (December 2022)
- Guidelines on “Medical and Scientific Information Provision” Conducted by the Medical Affairs Department (December 2022)
- Directions for Medical Education Meetings (December 2022)
- Methods for Estimating Treatment Efficacy for Rare Diseases (December 2022)
- Guidelines for Preparing the “Post-Marketing Surveillance Implementation Plan” and “Post-Marketing Surveillance Implementation Report” (Revised Edition, 2022) (December 2022)
- Issues to Be Addressed to Promote the Sharing of Clinical Trial Data (December 2022)
- Introduction to Sequential Multiple Assignment Randomized Trials (SMART) (November 2022)
- Considering the Future of Clinical Research in the Face of Transformation (October 2022)
- Current Status and Challenges of DDC/EHR Data Integration (September 2022)
- Guidelines for the Electronic Preparation of Adverse Drug Reaction and Infectious Disease Case Reports, etc. – E2B(R3) Compliance – (2022 Edition: Explanation) (September 2022)
- Causal Inference to Aid Understanding of ICH E9(R1): Time-Dependent Treatments (September 2022)
- DM Transformation Topic: “Data Flow in DCTs and Ensuring Data Reliability” (August 2022)
- DM Transformation Topic: “Efficient DM Operations Based on Fitness for Purpose” (August 2022)
- Drug Evaluation From Now On --- What's the value of local data in the global clinical data package? (December 2022)
- Causal Inference to Aid in Understanding ICH E9(R1) (July 2022)
- The Direction MSLs Should Aim For (July 2022)
- Points to Note When Using Real-World Data as an External Control in Regulatory Submissions (July 2022)
- Examination of Challenges in Ensuring the Reliability of Post-Marketing Database Surveys (June 2022)
- Let’s Learn About “Medicines” and “Clinical Trials”! (Audio Explanation) (April 2022)
- Guidelines for Preparing “Electronic Package Inserts for Prescription Drugs” — Compliant with the Heisei 29 and Reiwa 3 Writing Guidelines — (Reiwa 4 April Edition) (April 2022)
- Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) – 2nd Edition (April 2022)
- Form Recommended by the JPMA for Communicating Safety Information to Investigator Sites (April 2022)
- Tips for Implementing and Utilizing a Quality Management System in Pharmacovigilance (April 2022)
- Study on Promoting the Utilization of Registries for Pediatric, Rare, and Intractable Diseases (April 2022)
- Points to Note Regarding the Protection of Personal Information in Pharmaceutical Development and Secondary Use of Data (April 2022)
- Data Integrity Regarding Computerized Systems in the GCP Domain (For Management) (April 2022)
- Utilization and Requirements of Digital Biomarkers (dBM) in Drug Development (April 2022)
- Current Status and Challenges of eConsent in Drug Development (April 2022)
- Requirements for the Digitization of Paper Originals of Clinical Trial-Related Documents (Focusing on the Use of Certified Copies) (April 2022)
- Summary of Survey Results on Remote Inspections (Re-examination and Other Compliance Inspections) (March 2022) (March 2022)
- Features of Digital Certificates Used in the Electronic Data Submission System (March 2022)
- Explanation of Basic Principles for Utilizing eTMF (electronic Trial Master File) and TMF Metrics (March 2022)
- Guidebook for Pharmaceutical Companies to Implement Patient-Centric Activities (2022 Edition) (March 2022)
- Maintenance of J-RMPs as Seen Through Company Case Studies—Proposals for Appropriate Pharmaceutical Risk Management—(Reiwa 4 March Edition) (March 2022)
- Current Status and Considerations for RPA Implementation in Pharmacovigilance Operations (February 2022)
- Set of Presentation Slides on Methods for Introducing and Utilizing Clinical Trial Methods Not Dependent on Visits to Healthcare Facilities (January 2022)
- Is Population Adjustment Useful in Indirect Comparisons? (January 2022)
- Guidance on Remote Inspections (Re-inspection) (May 2023) (May 2023)
- Toward Achieving Appropriate Clinical Trial Costs in Japan (Audio Explanation) (December 2021)
- Introduction to NICE TSD and Model Creation (November 2021)
- Guidance on Re-examination Applications (October 2021)
- Introduction to NICE TSD and QOL Scores (October 2021)
- Guidance on Periodic Safety Reports (September 2021)
- Manual for Submitting “Electronic Package Inserts for Prescription Drugs” (Reiwa 3 August Edition) (August 2021)
- Japanese Translation of FDA Guidance on Adaptive Designs (August 2021)
- Considerations for the Utilization of Clinical Trial Methods Not Dependent on Visits to Healthcare Facilities—A Guide to Implementation in Japan— (August 2021)
- Get Started Today! Process Management for Clinical Trials Conducted at Medical Institutions (July 2021)
- Q&A Regarding the Conduct of Medical Education Meetings and Medical Booths (July 2021)
- Points to Consider When Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) in Pharmaceutical Risk Management Plans (RMPs) (June 2021)
- Guidance on Preparing Adverse Event Reports for Combination Products Classified as Pharmaceuticals (2021 Edition) (June 2021)
- Innovative Changes in Data Management (June 2021)
- Guidance on Providing Information on “Electronic Package Inserts for Prescription Drugs” (May 2021)
- Considerations on Trial Design and Statistical Evaluation Methods in the Development of Regenerative Medicine Products (May 2021)
- Drug Development Utilizing Real-World Data and Disease Registries (May 2021)
- Guidance on Preparing a Pharmaceutical Risk Management Plan (J-RMP) (April 2021)
- Innovative Changes in Data Management (Full Version): Introduction to SCDM Reflection Papers “The Evolution of Clinical Data Management to Clinical Data Science” (April 2021)
- Explanation of Revisions to Notifications Regarding Re-examination, Periodic Safety Reports, and Compliance Investigations for Fiscal Year 2020 (March 2021)
- Study on Data De-identification Methods for CTDS (Clinical Trial Data Sharing) (February 2021)
- CDISC and Electronic Data Submission-Related Documents Resource Collection (4th Edition) (February 2021)
- Notice of Publication of the Guide to Creating XML Files for Clinical Trial Notifications (4th Edition) (February 2021)
- Central Monitoring (December 2020)
- Points to Note When Conducting Post-Marketing Database Surveys on Pharmaceuticals Using Medical Information Databases, etc. (December 2020)
- Introduction to the NICE TSD Evidence Synthesis Series: Focusing on Network Meta-Analysis (December 2020)
- Handling of Safety Information in Clinical Trials (December 2020)
- Innovative Changes in Data Management (November 2020)
- Points to Note Regarding Data Collection in Post-Marketing Surveillance Studies (October 2020)
- Considering the Future of Clinical Research in the Era of Transformation (October 2020)
- Considerations for the Introduction and Utilization of Clinical Trial Methods Not Dependent on Visits to Medical Institutions (September 2020)
- Translation: Statistical Challenges and Recommendations for Conducting Clinical Trials During the COVID-19 Pandemic (July 2020)
- Survey Report on the Utilization of Safety Information in Clinical Trials (June 2020)
- Current Status and Future Challenges Regarding Issues of Multiplicity in Clinical Trials (June 2020)
in the Era of Globalized Drug Development Considerations Regarding the Handling of Safety Information During Clinical Trials (June 2020)- What Is Blockchain? (June 2020)
- Considering the Disease Registry Ecosystem (June 2020)
- “Guidance on Preparing the Drug Product Interview Form (Revised Edition)” (May 2020)
- We’ve Started Using Machine Learning. (May 2020)
- Toward the Development of Safety Monitoring Plans in Accordance with “Guidance on the Process for Formulating Implementation Plans for Post-Marketing Surveys of Pharmaceuticals, etc.” (May 2020)
- Utilizing Real-World Data in Drug Development (May 2020)
- Regulations Related to CTDS (Clinical Trial Data Sharing) and Key Considerations for Compliance (April 2020)
- Case Study on Clinical Pharmacology Trials and Clinical Pharmacology Evaluation of Anticancer Drugs for Domestically Approved Products (April 2020)
- Overview of eSource (DDC and EHR) and Considerations for Implementation (April 2020)
- Streamlining Computerized System Validation in the GCP Domain (March 2020)
- Manual for Submitting “Prescribing Information for Prescription Drugs” (Reiwa 2 March Edition) (March 2020)
- Mapping List of Clinical Trial-Related Documents in Japan for the Trial Master File Reference Model Ver. 3.0 (March 2020)
- “Checklist for Pharmaceutical GPSP Compliance Surveys” (March 2020)
- “Basic Approach to Compliance with Electronic Regulations: Regarding the Use of Electronic Records and Electronic Signatures in Applications for the Approval or Authorization of Pharmaceuticals, etc.”, 4th Edition (March 2020)
- Introduction to the “Framework for the FDA’s Real-World Evidence Program” (March 2020)
- Statistical Methods for Estimating Treatment Effects Using Data from Non-Randomized Comparative Trials (February 2020)
- Maintenance of the J-RMP as Seen Through Corporate Case Studies (February 2020)
- Issues in Survival Time Analysis for Cost-Effectiveness Evaluations (February 2020)
- Cost-Effectiveness Analysis Using Patient-Level Models (December 2019)
- Commonly used analysis shells and ADaM data for clinical study reports (December 2019)
- Overview and Considerations for Network Meta-Analysis (November 2019)
- Considerations for Formulating Additional Risk Minimization Activities in a Risk Management Plan (RMP) (October 2019)
- For Sharing Individual Participant/Patient Data (IPD) from Clinical Trials (October 2019)
- Drug Development Incorporating Patient Perspectives (September 2019)
- JPMA Q&A on the “Clinical Research Act and Enforcement Regulations of the Clinical Research Act” (August 2019)
- Literature Review on Estimands and Sensitivity Analysis in Clinical Trials (June 2019)
- Analysis of the Current Status and Future Outlook of Disease Registries in Pharmaceutical Development (June 2019)
- Guidance on Creating Electronic Files for Prescribing Information for Prescription Drugs—XML Format—Announcement of the Release of the First Provisional Edition (May 2019)
- What Is AI? (May 2019)
- Manual for Filing “Prescribing Information for Prescription Drugs” (Reiwa 1, May Edition) (May 2019)
- To What Extent Can Existing Domestic Real-World Data Be Utilized in Drug Development? (May 2019)
- Toward the Realization of Appropriate Clinical Trial Costs in Japan (May 2019)
- Recommendations for Sensitivity Analysis in Observational Studies: Practical Guide (April 2019)
- Considering the Future of Clinical Research in the Era of Transformation (April 2019)
- Notice of Publication of the Guide to Creating XML Files for Clinical Trial Notifications (3rd Edition) (March 2019)
- Guide to Preparing Explanations for the “Precautions for Use” of New Drugs (March 2019)
- Evaluation Measures for Survival-Type Endpoints (2nd Edition) (March 2019)
- “RMP Training Slides for Medical Representatives” and “RMP Explanation Slides by Medical Representatives (Slide Template for Explaining the RMP to Healthcare Institutions)” (March 2019)
- “Explanatory Materials for the New Guidelines on Package Inserts for Prescription Drugs” (February 2019)
- Guidance on the Preparation of Drug Product Interview Forms (Revised Edition), Revised in Heisei 30 November (Provisional Version) (November 2018)
- The Role of Medical Institutions in Light of Changes in the Clinical Trial Environment (September 2018)
- Collection of Examples for Post-Marketing Database Investigation Implementation Plans (August 2018)
- “ICH E6(R2) Training Materials” (July 2018)
- Toward Establishing a Performance-Based Payment Method for Clinical Trial Costs in Japan (July 2018)
- Drug Development Incorporating Patient Feedback (June 2018)
- Considering the Future of Clinical Research in the Face of Transformation (March 2018)
- Current Status and Challenges of IoT Utilization in Drug Development (March 2018)
- Guide to Implementing a Regulatory Information Management System (RIMS) (February 2018)
- Report on the Analysis of the Current Status of Clinical Trial Networks and Findings Regarding Future Development (August 2017)
- Guidance on the Preparation of Electronic Common Technical Documents (eCTD) (Part 1: Revised Edition) (April 2017)
- Guide to Preparing Electronic Common Technical Documents (eCTD) (Part 3, Revised Edition) (April 2017)
- Points to Consider When Formulating a Risk Management Plan (RMP) for Medicinal Products, Taking into Account Their Use by Healthcare Professionals (March 2017)
- Japanese Translations of FDA eCTD-Related Notices (January 2017)
- An Introduction to Developing a Pharmaceutical Risk Management Plan (December 2016)
- Guidance on the Preparation of the Electronic Common Technical Document (eCTD) (Part 4, Revised Edition) (October 2016)
- Guidance on the Preparation of the Electronic Common Technical Document (eCTD) (Version 4.1, English Translation) (October 2016)
- Building Effective Collaborative Relationships Between Pharmaceutical Companies and CROs: From Client-Contractor Relationships to Trusted Partnerships (September 2016)
- Principles of Monitoring Operations (Ideal Practices) (August 2016)
- Guidance on eCTD Preparation, Version 4.2: Gateway-Compliant Edition (August 2016)
- Survey on Benefit-Risk Assessment of Post-Marketing Drugs: “Based on the Findings of IMI-PROTECT” (July 2016)
- Japanese Translation of the EU Module 1 eCTD Specification (July 2016)
- Report on the Study of Efficient Feasibility Study Methods (June 2016)
- Manual for Filing “Prescribing Information for Prescription Drugs” (Heisei 28 March Edition) (March 2016)
- Points to Note Regarding the Electronic Storage of Clinical Trial-Related Documents (March 2016)
- Regarding the ICH M2 Recommendation (PDF/A and DOCX) (February 2016)
- Toward the Widespread Adoption of ePROs (February 2016)
- Guide to eCTD Preparation (Version 4.1) (February 2016)
- Toward the Establishment of a Healthcare Facility-Led Quality Management System (June 2015)
- Report on Activities to Revitalize the Clinical Trial Network (May 2015)
- Overview of the Risk Management Plan (RMP) for Pharmaceuticals: A Study on Its Development and Utilization (May 2015)
- Study on the Appropriate Setting of Medical Institution Costs in Clinical Trials (April 2015)
- Survey Results on eCTD Adoption Status (March 2015)
- Considering the Future of Clinical Research in the Face of Transformation (2015)
- Establishing Safety Considerations and Research Questions (Research Questions) for the Practical Implementation of Scientific Risk Management Plans (RMPs) for Pharmaceuticals (August 2014)
- “Model Operational Procedures for Pharmaceutical Risk Management Plans” (August 2014)
- Guidance on Developing a Risk Management Plan (RMP) for Pharmaceuticals (August 2014)
- Points to Note Regarding Regulatory Amendments on Adverse Event Reporting, Including Periodic Reports (Revised Edition) (May 2014)
- Examining Management Operations at Medical Institutions (April 2014)
- Points to Consider for Pharmaceutical Companies and Contract Development Organizations to Build and Maintain Better Collaborative Relationships (February 2014)
- RMP Awareness Materials (August 2013)
- Survey Results on the Current Status of Clinical Trial Networks in Japan 2012 (May 2013)
- Requirements for an Ideal Clinical Trial Network and Self-Assessment (May 2013)
- Analysis of the Domestic Clinical Trial Environment and Consideration of Areas for Improvement (March 2013)
- Sponsors’ Perspectives on the Use of Joint IRBs (Including Central IRBs) (April 2012)
- Recommendations on Quality Management Processes for the Efficient Conduct of Clinical Trials (April 2012)
- File Verification Tool for Companies Regarding Adverse Event Reports from Healthcare Facilities to the Agency (Agency Investigation Portion) (February 2012)
- Detailed Investigation Form for Adverse Event Investigations (JPMA Model) (February 2012)
- Explanation of the CDASH Standard Defining Data Fields in Case Report Forms (December 2011)
- Division of Roles in International Clinical Trials (May 2011)
- Proposal for a New Clinical Trial Cost Calculation Method Based on Work Accumulation (March 2009)