Drug Evaluation Committee All Deliverables of the Drug Evaluation Committee
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(New arrivals first)
- A Beginner's Guide to the Use of NDBs in Pharmaceutical Companies (April 2026)
- Results of Questionnaire for Pharmaceutical Companies on Post-Marketing Surveillance (April 2026)
- Common Template for Explanatory and Consent Documents (ICF) (April 2026)
- Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 Edition) (April 2026) (April 2026) (April 2026)
- Ban on "taking medical/health information for granted! Educational materials (collaboration among three organizations) (April 2026)
- Handbook of Regulatory Requirements and Publications for Electronic Information (April 2026)
- Contribution of Clinical Pharmacology to Ensuring Diversity in Drug Development - Toward Closing the Gap in Patient Background between Real Clinical Trials and Clinical Trials - (April 2026) (April 2026)
- Consideration of computerized system validation support when a requester builds a DCT system on the subject of eConsent system (April 2026)
- Overview of the "Risk-Based Credibility Assessment of AI Models" Framework proposed by the FDA (April 2026)
- Results of a Fixed Point Survey of Patient and Public Involvement Activities in Drug Development by Pharmaceutical Companies (March 2026) (March 2026)
- Systematic Survey on RWD/RWE - FDA Approval Cases and Approaches to Challenges with Innovative Technologies - (April 2026) (April 2026)
- Considerations - Survey to assess the needs of healthcare professionals regarding drug safety information (physicians and pharmacists) Conducted in May 2023 (April 2026)
- Guidance for Notification of "Electronic Attachments of Ethical Drugs" -April 2026 Edition- (April 2026)
- Report on the Fact-Finding Survey on Publication in Medical Affairs (March 2026)
- Toward the Utilization of Structured Data in Clinical Trial Notification (March 2026)
- Checklist for Voluntary Quality Tests_ver.1 (March 2026)
- Points to keep in mind when transferring TMF data (March 2026)
- Q&A on Application for Authorized Pseudonymous Processed Medical Information User Business Operator under the Next Generation Medical Infrastructure Act (March 2026) (March 2026)
- Report on the Explanatory Meeting for the Detailed Questionnaire (JPMA electronic model) used for Adverse Reaction Surveillance (March 2026)
- Actual Conditions and Challenges of Database Research in Medical Affairs: A Comprehensive Analysis Based on Questionnaire Survey and Paper Survey (2025 Survey) (March 2026)
- Toward the Use of Wearable Devices Publication (March 2026)
- Information and background needed for companies to take advantage of disease registries. (March 2026)
- Report on Communication Challenges when Introducing DCT - Communication Risk Minimization Approach to Maximize the Benefits of DCT - Notice of Publication (February 2026)
- Impact of the Notification related to the "Study Group on the Regulation of Pharmaceutical Affairs to Strengthen Drug Discovery Capability and Ensure Stable Supply, etc." as revealed through the results of the survey in the pharmaceutical industry (February 2026)
- Hands-on Workshop on Utilization of Medical Information Databases in PV Activities (held in September 2025) Video of Dr. Chieko Ishiguro's Lecture "Possibility of Utilizing Medical Databases in Normal Safety Surveillance Activities" Available to the Public. (February 2026)
- Survey and analysis of clinical data packages for approved items (April 2026)
- Q&A on the Clinical Research Act, Enforcement Regulations of the Clinical Research Act, and Related Notices (January 5, 2026) (January 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)
- Asian eCTD / Gateway System Information Publication (December 2025)
- Questionnaire results on information provision activities at the time of revision of "precautions for use
-Trends of each company after the revision of the "KENSENSHU GUIDELINES" - (December 2025) (December 2025) - Review of the first 10 years since the introduction of the RMP system from the standpoint of the pharmaceutical industry (December 2025)
- Publication of Presentation Material for eCTD v4 Implementation Promotion Symposium (November 28, 2025, Web-based) (December 2025) (December 2025)
- Slide presentation "From the Pharmaceutical Industry - "How Do You Want Us to Utilize? Thoughts on Various Materials" (November 1, 2025, 19th Annual Meeting of the Japanese Society of Pharmacognosy) (December 2025) (December 2025)
- Preliminary study of the application of AI to quality management of clinical trials - Aiming to foster a quality culture with AI as a companion. (December 2025) (Implemented in December 2025)
- Data Linkage Concept - Data Linkage from Overseas Regulations (2nd periodic activity report) (November 2025)
- Guidance for Conducting Post-Marketing Database Surveillance -November 2025 Edition- (November 2025) (November 2025)
- Evolution and Advancement of Data Management in Drug Development(Executive Summary) (November 2025)
- Presentation slides "Pharmaceutical Industry Initiatives to Promote RMP/RMP Material Utilization" (July 5, 2025, 27th Assembly and Annual Meeting of the Japanese Society for Drug Informatics) (November 2025)
- Investigation of the use of pharmaceutical risk management plans (RMPs) and preparation of a collection of use cases" (November 1, 2025, 19th Assembly of the Japanese Society of Pharmacy) (November 2025) Slide presentation (November 2025)
- eCTD v4 Preparation Guide Version 1.0 was released. (November 2025)
- Guidance for Conformity Surveillance for Reexamination, etc. (October 2025)
- Quality and Non-clinical Compliance Documentation Survey Q&A (October 2025)
- Impact on drug development after the introduction of ICH M11 (October 2025)
- Questionnaire Report on the Promotion of eSource Utilization such as Electronic Medical Records (October 2025)
- RMP training slides for MRs (revised August 2025) (October 2025)
- Lecture Slide: "Shaping the Thoughts of Pharmaceutical Companies - Challenges in Delivering Appropriate Drug Information to Patients" (October 13, 2025, 58th Annual Meeting of the Japanese Pharmacists' Association) (October 2025)
- How to Use Simulation in Bayesian Flow Study Designs (October 2025)
- Survey Report on Drugs Designated under the Pioneering Review and Designation System and the Pioneering Drug Designation System (October 2025)
- Scientific Arguments Learned from FDA Review Report (September 2025)
- Tips for Signal Management Activities in Japan (August 2025)
- Results of Questionnaire on Preparation and Sharing of Clinical Trial Results (August 2025)
- JPMA Web site release] PV: KT5 Pharmacovigilance Regulatory Survey Report Form (August 2025)
- Slide presentation "Provision of information on adverse drug reactions: How information should be provided for the next generation" (July 25, 2025, 16th Annual Meeting of the Japanese Society of Pharmaceutical Medicine) (August 2025)
- JPMA website] PV: KT1 Case studies of the use of RMP/RMP materials - mainly for dispensing pharmacies - (July 2025) (July 2025) (in Japanese)
- Guidance for Efficient Preparation of Regulatory Documents (CSR and CTD (Clinical Tables)) in Response to Changes in the Environment (July 2025)
- Presentation slides, "Current Status and Issues of Post-Marketing Surveillance, etc. in Japan - GPSP Questionnaire Survey" (July 5, 2025, 27th Annual Meeting and Conference of the Japanese Society for Drug Information) (July 2025)
- Slide presentation "Delivering the Latest Information Patients Need - From a Pharmaceutical Company's Perspective" (July 6, 2025, 27th Annual Assembly of the Japanese Society for Drug Information Research) (July 2025)
- Do you know about the "drug use-results survey" conducted by pharmaceutical companies? (July 2025)
- RMP Follow-up Survey on the Implementation Status of Post-Marketing Surveillance, etc. (1st interim results) (July 2025) (July 2025)
- Guidance for the Preparation of Defect Reports for Drug Combination Products (2025 Edition) (July 2025) (July 2025)
- English version of Checklist and Q&A_ver.1 for Voluntary Inspection for Non-clinical Studies (July 2025) (July 2025)
- Assessment of the Validation Required to Use Digital Biomarkers as Primary Endpoints in Clinical Trials (July 2025)
- Covariate Adjustment for Randomized Controlled Trials in Light of FDA Guidance (June 2025)
- The Dawn of the ICH E6 (R3) Era: The Future of Clinical Data Manager -Summary of the sections related to CDM- (June 2025) (June 2025)
- A Guide for Medical Writers to Prepare Pharmaceutical Documents in Response to Changes in the Environment of Generated AI and Other Digital Technologies (June 2025)
- Comparison of guidance related to RWD/RWE utilization in Japan and the U.S. (May 2025)
- Report of the Roundtable on Issues and Prioritization for the Utilization of RWD and RWE (May 2025) (May 2025)
- Current Status and Issues of Digital Therapeutics (DTx) in Japan
-Comparison with German and U.S. Systems- (May 2025) (May 2025) - Reference Manual for the Clinical Development of Regenerative Medicine Products (May 2025)
- Handbook on Regulatory Requirements and Publications of Digitized Information (May 2025)
- Utilization of Patient Experience Information for Patient-Focused Drug Development
Utilization of Patient Experience Information for Patient-Focused Drug Development - For Decision-Making Based on Patients' Opinions (April 2025) - Model Credibility Assessment in Drug Development (April 2025)
- Patient Reported Outcomes in Clinical Trials - A Guide to Using PROs for Clinical Development Professionals (Reprinted April 2025)
- ICH M11 "Electronically Structured and Harmonized Clinical Trial Protocols (CeSHarP)" Questionnaire Results for Domestic Implementation (FY2024) (March 2025)
- Guidance for the Preparation of Periodic Reporting of Infectious Diseases (Revised 2025) (March 2025)
- Leaflet: What is Medical Affairs (MA) for Pharmaceutical Companies? (March 2025)
- How to proceed with the study of post-marketing database survey using the registry - February 2025 edition - (March 2025)
- Study of simulation for planning adaptive design. (February 2025)
- Points to keep in mind when conducting indirect comparisons in cost-effectiveness evaluations (February 2025)
- A Guide to Viewing the "Video on Reexamination Compliance Surveillance" Distributed by PMDA (February 2025) (February 2025)
- Handling of missing data in clinical trials (February 2025)
- Guidance for Preparation of Drug Risk Management Plan (J-RMP) -January 2025 Edition- (January 2025) (January 2025)
- Utilization of real-world data in cost-effectiveness assessment -lessons learned from the NICE real-world evidence framework and the status of real-world data utilization in Japan- (January 2025) (January 2025)
- OSS Usage Questionnaire Report for FY2024 (January 2025)
- Consideration of Pseudonymization Techniques in the Preparation of Pseudonymized Information, etc. (December 2024)
- RMP General Theory (including the latest information on the revision of medical fees, etc.) (November 3, 2024) Slide presentation at the Society of Medicinal Pharmacology and Pharmaceutical Sciences (December 2024)
- Translation: FDA Guidance on RWDs (November 2024)
- ICH E19 "Selective Approach to Safety Data Collection in Certain Clinical Trials Conducted after Approval or Approval in the Late Stage of Development" Points to keep in mind when conducting applicable studies - mainly from the perspective of data management (November 2024)
- eCTD v4.0 Educational Materials, Version 2 Available Now! (November 2024)
- Transparency checklist for de-identified/anonymized data sharing - from the checklist prepared by TransCelerate (November 2024)
- Explanation of "Procedural Guidance for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Q&A on Investigation of Usage Results for Ethical Drugs Using the All-Patient Surveillance Method (October 2024)
- Questionnaire results on the status of DCT implementation and each method of DCT (October 2024)
- Approaches to QMS implementation by sponsors - Fostering a culture of quality and leadership (September 2024)
- How to Find Clinical Trials - How to Use jRCTs - 3rd Edition (April 2025)
- Survey on Patients' and Families' Access to Drug Information -Preliminary Report- (February 2024) (July 2024) (July 2024)
- Overview of FDA CSA Draft Guidance and Discussion and Consideration of its Application to the GxP Domain (July 2024)
- Outline and key points of the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects (July 2024)
- Questionnaire for understanding the current status of post-marketing DB surveys (Feasibility Study/Reliability Confirmation) Report (July 2024)
- Prototype Model for Investigating the Use of AI in Data Management Operations (June 2024)
- Explanation of the RMP Mark (Revised 2024) (June 2024)
- Challenges and Causal Analysis of Health Communication between Patients/Citizens and Pharmaceutical Companies (June 2024)
- Causal Inference for Interpretation - Causal Mediated Analysis Edition (June 2024)
- Conveying Clinical Trial Information in an Easy-to-Understand Way: For Pharmaceutical Companies Creating Documents for Non-Professionals. (June 2024)
- Issues of pharmaceutical documents and proposals for the use of digital technology toward Society 5.0 (Data Society) (June 2024) (June 2024)
- Meeting on Smooth Implementation of Electronic Data Submission: "Results of Questionnaire on Consultation on Electronic Data Submission Exemption" and "Information Sharing on SDTMIG v3.3 and Define-XML v2.1" (June 2024) (June 2024)
- Open Source Software Application Case Study (June 2024)
- Utilization of medical information DB (June 2024)
- Recommendations on the collection and reporting of safety data (May 2024)
- Promotion of consistent quality management as a clinical trial (May 2024)
- Medical Device Program (SaMD) Development Overview (May 2024)
- Digital Transformation (DX) in Clinical Development: Current Status and Opportunities (May 2024)
- Guidance for "Periodic Safety Reporting"-Gateway System Use Edition- (May 2024) (May 2024)
- Expectations for Policies and Other Measures to Promote 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) (May 2024)
- Complex Innovative Trial Design: Current Status and Case Studies - FDA Guidance with Japanese Translation (April 2024) (April 2024)
- Report on the Results of a Questionnaire on Patient Involvement in Clinical Trials (April 2024)
- Efficient CSV documentation using vendor documentation (April 2024)
- Education and Training Materials for the E2B(R3) Explanation (April 2024)
- Introduction of Single Sign-On (SSO) usage for the current status of account management of clinical trial-related IT systems (April 2024)
- Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 version) (April 2024) (April 2024)
- Common Master (Medical Institution Related Information) for Utilization of Clinical Trial Related Systems (April 2024)
- Guidance for Remote Investigation (Reexamination) Ver3.0 (March 2024) (April 2024)
- Glossary of Health Care Data (April 2024)
- Guidance for Preparation of "Electronic Attachments for Ethical Drugs" (Revised edition, April 2024) (April 2024)
- Guidance for Reexamination Application -Gateway System Utilization- (March 2024) (March 2024)
- Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (Revised 2024) (March 2024) (March 2024)
- Q&As on "Registration of Clinical Trials" (No. 9 of 0831 issued by the Pharmaceutical Affairs Agency on August 31, 2020) (4th Edition) (February 2024)
- Guidance for Providing Information on Electronic Attachments for Ethical Drugs (February 2024)
(February 2024) - Electronic Detailed Questionnaire for Adverse Event Surveillance (JPMA electronic model) (February 2024) (February 2024)
- How to Find a Clinical Trial - jRCT Mikata" Educational Material (April 2025)
- Results of Questionnaire on Electronic Provision of Information - Trends in JPMA Participating Companies (conducted in January 2023) (January 2024)
- Guidance for Conducting Post-Marketing Database Surveillance - January 2024 Edition (January 2024) (January 2024)
- Report on the Actual Situation and State of Database Research in Medical Affairs (January 2024)
- Guidance for Conformity Surveys, including Reexaminations (December 2023)
- Quality Control - Fraud Detection Prevention (December 2023)
- Introduction of "Collection and Management of Safety Data in Clinical Trials" from CIOMS Working Group VI Report, Chapter 4 (December 2023)
- Quality Control in Drug Development -A Study on the State of Risk Communication- (December 2023) (December 2023)
- Issues and Current Status of Bioequivalence Assessment for Drugs with Large Intra-individual Variation (December 2023)
- Survey to understand the needs of healthcare professionals regarding drug safety information (physicians and pharmacists) - Preliminary report - conducted in May 2023 (December 2023)
- Pharmaceutical Risk Management Plan (RMP) Comparative Study on the Development Status of Additional Risk Minimization Activities in Japan, the U.S. and Europe (November 2023) (November 2023)
- Results of Questionnaire on the Provision of Information to Patients Using Digital Technology (conducted by companies participating in the PV Subcommittee, January-February 2023) (October 2023)
- List of Registration Items for Studies Transitioning from JapicCTI First Edition
Comparative Table of jRCT-JapicCTI Registration Items, 2nd ed. (October 2023) - Fact-finding Study on Model-Informed Drug Development through Investigation in Domestic Approved Products (October 2023)
- Data Linkage Initiative - Recommendations from the Field of Medicine and Clinical Trials (August 2023)
- Paper on eConsent practices and measures to resolve issues (August 2023)
- Notes on Regulatory Revisions Concerning the Handling of Safety Information on Investigational Products in Clinical Trials (August 2023) (August 2023)
- CTD Structure Using the Results of Multi-Regional Clinical Trials Based on the Principles in ICH E17 (December 2023)
- Guidance for Notification of "Electronic Attachment of Ethical Drugs" (August 2023 Edition) (August 2023)
- Ensuring the Quality of Effective and Efficient Clinical Trials Based on the Quality by Design Concept - Aiming for Consistent Quality Management from Planning to Implementation - (July 2023) (July 2023)
- Q&A for Checklist for Voluntary Inspection for Non-clinical Studies_ver.1 (July 2023)
- Flexible Survival Time Modeling Methods and Extrapolation of Survival Times Using External Information (June 2023)
- Recent Cancer Phase I Trial Designs and Selection (June 2023)
- Issues and Prospects for Efficient Clinical Trials through Standardization of Medical Information Based on HL7 FHIR and Data Linkage with Electronic DataCatheter EDC, etc. (June 2023)
- Survey and Discussion of the Current State of Digital Health in the Pharmaceutical Industry (June 2023)
- The ideal Clinical Data Manager and skill set of the future Clinical Data Manager
～Focusing on Vendor Oversight, QMS, and DCT (May 2023) - Application of Artificial Intelligence in Data Management - Starting with AI - (May 2023) (May 2023)
- Multivariate Meta-Analysis and Alternative Endpoints in Health Technology Assessment (May 2023)
- Translation: Data Quality Framework for EU Medicines Regulation (May 2023)
- RMP Training Slides for MRs" and "Overview Version_RMP Explanation Slides by MRs (Slide Template for RMP Explanation for Medical Institutions)" (May 2023) (May 2023)
- Q&A on "Points to Consider Regarding the Protection of Personal Information in the Development of Pharmaceutical Products and Secondary Use of Data (April 2023)
- Utilization of Open Source Software and Points to Keep in Mind" and "OSS Utilization Status Questionnaire Report" (April 2023) (April 2023)
- Health Care Data and Our Lives (April 2023)
- Checklist for Voluntary Inspection of Non-clinical Studies_ver.1 (March 2023)
- Implementation of Estimand into Clinical Trial Protocols (March 2023)
- Considerations for Cost-Effectiveness Assessment Learned from Case Studies (March 2023)
- eCTD v4.0 Educational Materials (March 2023)
- Basic Concepts on Safety Forms for Clinical Trials (February 2023)
- Study on Statistical Inference for Adaptive Design (February 2023)
- Results of Questionnaire Survey of Pharmaceutical Companies on the Current Status of Clinical Trials (January 2023)
- Guidance for Preparation of the Drug Risk Management Plan (J-RMP) -January 2023 Edition- (January 2023) (in Japanese) (January 2023)
- Internal process flow for utilizing the registry for drug approval applications, etc. (from internal proposal to registry modification) (December 2022)
- Guidance on "Provision of Medical and Scientific Information" by the Medical Affairs Division (December 2022)
- The Direction of the Medical Education Meeting (December 2022)
- Estimation of Therapeutic Effectiveness for Rare Diseases (December 2022)
- Guidance for Preparation of "Post-marketing Surveillance Protocol" and "Post-marketing Surveillance Report" (revised edition in 2022) (December 2022) (December 2022)
- Issues to be resolved to promote the sharing of clinical trial data (December 2022)
- Sequential Multiple Assignment Randomized Trials (SMART) (November 2022)
- Thinking about the Future of Clinical Research, which is undergoing a Transformation (October 2022)
- DDC/EHR Data Linkage Status and Issues (September 2022)
- Guidance for preparation of electronic adverse drug reaction and infection case reports -E2B(R3)- (Explanation of the 2022 edition) (September 2022) (September 2022)
- Causal Reasoning for Understanding ICH E9(R1) - Time Dependent Treatment (September 2022)
- DM Transformation Topic "Data Flow in DCT and Ensuring its 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 Reasoning for Understanding ICH E9(R1) (July 2022)
- Direction of MSL (July 2022)
- Points to keep in mind when using Real World Data as external controls for regulatory submissions (July 2022)
- Examination of Issues for Ensuring Reliability of Post-Marketing Database Surveys (June 2022) (in Japanese) (June 2022)
- Let's learn about "Pharmaceuticals" and "Clinical Trials"! (Audio description) (April 2022)
- Guidance for Preparation of "Electronic Attachments of Ethical Drugs" -Corresponding to the Guidelines for Description in 2009 and 2021 - (April 2022 edition) (April 2022)
- Pharmaceutical Risk Management Plan (RMP) Notes for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials), 2nd ed. (April 2022)
- JPMA Recommended Form for Communicating Safety Information to Investigator Sites (April 2022) (April 2022)
- Tips for Implementing and Utilizing Quality Management System in PV (April 2022)
- Study on promotion of utilization of the registry for children, rare diseases and intractable diseases (April 2022) (April 2022)
- Points to keep in mind regarding the protection of personal information in drug development and secondary use of data (April 2022) (April 2022)
- Data Integrity Regarding Computerized Systems in the GCP Area (for management) (April 2022)
- Utilization of Digital Biomarkers (dBM) in Drug Development and Requirements (April 2022)
- Current Status and Challenges of eConsent in Drug Development (April 2022)
- What is required for the digitization of paper originals of clinical trial-related documents (focusing on the operation of Certified Copy) (April 2022)
- Results of Questionnaire on Remote Surveys (Conformity Surveys for Reexamination, etc.) (March 2022) (March 2022)
- Characteristics of Electronic Certificates Used in the Application Electronic Data System (March 2022)
- Explanation of basic items for the use of eTMF (electronic Trial Master File) and TMF Metrics (March 2022)
- Guidebook for pharmaceutical companies to implement Patient Centricity-based activities (2022) (March 2022)
- Maintenance of the J-RMP as Seen from Company Case Studies -Proposals for Appropriate Drug Risk Management- (March 2022 edition) (March 2022)
- Current Status and Considerations for Introducing RPA into PV Operations (February 2022)
- A collection of slides explaining how to introduce and utilize clinical trial methods that do not rely on visits to medical institutions (January 2022)
- Is the population adjustment method useful in indirect comparisons? (January 2022)
- Guidance for Remote Investigation (Reexamination) (May 2023) (May 2023)
- Toward the Realization of Reasonable Clinical Trial Costs in Japan (Audio Explanation) (December 2021)
- Introduction and modeling of NICE TSD (Nov 2021)
- Guidance for reexamination application (October 2021)
- NICE TSD Introduction and Quality of Life Values (October 2021)
- Guidance for Periodic Safety Reporting (September 2021)
- Manual for Notification of "Electronic Attachments of Ethical Drugs" (August 2021 edition) (August 2021) (August 2021)
- Japanese translation of FDA guidance on adaptive design (August 2021)
- Study on the use of clinical trial methods that do not depend on visits to medical institutions - Guidance for implementation in Japan. (August 2021)
- Start Today! Process Management for Clinical Trials Conducted at Medical Institutions (July 2021)
- Q&A on the Implementation of Medical Education Meetings and Medical Booths (July 2021)
- Pharmaceutical Risk Management Plan (RMP) Notes for evaluating the effectiveness of additional risk minimization activities (materials) (June 2021)
- Guidance on preparing defect reports for combination products that are pharmaceutical products (2021 Edition) (June 2021)
- Innovative Changes in Data Management (June 2021)
- Guidance for providing information on "electronic package inserts for ethical drugs" (May 2021) (May 2021)
- Study Design and Statistical Evaluation Methods in the Development of Regenerative Medicine Products (May 2021)
- Drug Development Using Real World Data and Disease Registries (May 2021)
- Guidance for Preparation of Drug Risk Management Plan (J-RMP) (April 2021)
- Innovative Changes in Data Management (full version) SCDM Reflection papers "The Evolution of Clinical Data Management to Clinical Data Science" (April 2021)
- Explanation of the Notification Amendment for Reexamination, Periodic Safety Reporting and Conformity Surveillance in FY2020 (March 2021) (in Japanese)
- Examination of data de-identification methods for CTDS (Clinical Trial Data Sharing) (February 2021) (February 2021)
- CDISC and Electronic Data Submission Related Documents Resource Collection (4th Edition) (February 2021)
- Guidance for Creating XML Files for Clinical Trial Notification (4th Edition) Published (February 2021)
- Central Monitoring (December 2020)
- Points to keep in mind when conducting post-marketing database surveys of pharmaceuticals using medical information databases, etc. (December 2020) (December 2020)
- Introduction to the NICE TSD Evidence Synthesis series: with a focus on network meta-analysis (December 2020)
- Handling of Safety Information in Clinical Trials (December 2020)
- Innovative Changes in Data Management (November 2020)
- Notes on Data Collection in Post-Marketing Surveillance (October 2020)
- The Future of Clinical Research in a Changing World (October 2020)
- Study on the introduction and utilization of clinical trial methods that do not depend on visits to medical institutions (September 2020)
- Translation: statistical challenges and recommendations for conducting clinical trials under the COVID-19 pandemic (July 2020)
- Survey Report on the Status of Utilization of Safety Information Related to Clinical Trials (June 2020)
- Current and Future Issues of Multiplicity in Clinical Trials (June 2020)
- In the Era of Internationalization of Drug Development
A Study on Handling of Safety Information during Clinical Trials (June 2020) - What is Blockchain? (June 2020)
- Considering the Disease Registry Ecosystem (June 2020)
- Guidance for Preparation of Pharmaceutical Interview Forms (Revised Edition) (May 2020)
- Machine Learning Begins. (May 2020)
- Toward a Study on the Formulation of a Safety Surveillance Plan in accordance with "How to Proceed with the Study on the Formulation of a Plan for Conducting Post-Marketing Surveillance, etc. of Pharmaceuticals" (May 2020) (May 2020)
- Utilization of Real World Data in Drug Development (May 2020)
- Regulations related to CTDS (Clinical Trial Data Sharing) and points to keep in mind when responding to them (April 2020)
- Case study on clinical pharmacology study and clinical pharmacology evaluation of anticancer drugs in approved drugs in Japan (April 2020)
- eSource (DDC and EHR) Overview and Considerations for Implementation (April 2020)
- Efficiency of computerized system validation in the GCP area (March 2020)
- Manual for Notification of Medical Drug Attachments (March 2020 edition) (March 2020) (March 2020)
- Mapping List of Clinical Trial Documents in Japan to the Trial Master File Reference Model Ver3.0 (March 2020) (March 2020)
- Drug GPSP Conformity Assessment Checklist (March 2020)
- Basic Approach to Electronic Regulatory Compliance, including "Use of Electromagnetic Records and Electronic Signatures for Applications for Approval or Licensing of Drugs, etc.," 4th Edition (March 2020) (March 2020)
- Introduction of "Framework For FDAs Real World Evidence Program" (March 2020)
- Statistical Methods for Estimating Treatment Effects Using Non-randomized Controlled Trial Data (February 2020)
- Maintenance of J-RMP as seen through company case studies (February 2020)
- Issues in Survival Time Analysis for Cost-Effectiveness Evaluation (February 2020)
- Cost-Effectiveness Analysis Using Patient-Level Models (December 2019)
- Commonly used analysis shells and ADaM data for clinical study reports (December 2019)
- Network Meta-Analysis Overview and Notes (November 2019)
- Notes for the Development of Additional Risk Minimization Activities in the Pharmaceutical Risk Management Plan (RMP) (October 2019)
- For Sharing Individual Participant/Patient Data (IPD) from Clinical Trials (October 2019)
- Drug Development Based on Patients' Voices (September 2019)
- JPMA Q&A on "Clinical Research Act and Enforcement Regulations of Clinical Research Act" (August 2019)
- Literature review related to Estimand and sensitivity analysis in clinical trials (June 2019)
- Current Analysis and Prospects for Disease Registries in Drug Development (June 2019)
- Guidance for Creating Electronic Files of Attachment Information for Ethical Drugs - XML format - Provisional 1st edition published. (May 2019)
- What is AI? (May 2019)
- Manual for Notification of "Attachments to Ethical Drugs" (May 2028 edition) (May 2019)
- To what extent can existing domestic real world data be utilized for drug development? (May 2019)
- Toward the Realization of Appropriate Clinical Trial Costs in Japan (May 2019)
- Recommendations for Sensitivity Analysis in Observational Studies: A Practical Guide (April 2019)
- The Future of Clinical Research in a Changing World (April 2019)
- Notice of Publication of Guidance for Creating XML Files for Clinical Trial Notification (3rd Edition) (March 2019)
- Guidance for Preparation of Explanations for "Precautions for Use" for New Drugs (March 2019)
- Survival Time-Type Response Metrics (2nd Edition) (March 2019)
- RMP Training Slides for MRs" and "RMP Explanation Slides by MRs (Slide Template for RMP Explanation for Medical Institutions)" (March 2019) (March 2019)
- Explanatory Material for the New Guidelines for the Description of Ethical Drug Attachments (February 2019) (February 2019)
- Guidance for Preparation of Drug Interview Forms (Revised Version) Revised November 2018 (Provisional Version) (November 2018)
- How medical institutions should look ahead to changes in the clinical trial environment (September 2018)
- Collection of Examples of Post-Marketing Database Survey Implementation Plan (August 2018)
- ICH E6(R2) Training Materials" (July 2018)
- Establishing a Performance-Based Payment Method for Clinical Trials in Japan (July 2018)
- Drug Development Based on Patients' Voices (June 2018)
- The Future of Clinical Research in a Changing World (March 2018)
- Current Status and Issues of IoT Utilization in Drug Development (March 2018)
- Guidance on the introduction of Regulatory Information Management System (RIMS) (February 2018)
- Report on the Analysis of the Current Status of Clinical Trial Networks and the Results of a Study for Their Future Development (August 2017)
- Guidance for the Preparation of Electronic Common Technical Documents (eCTD) (Part 1, Revised) (April 2017)
- Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Part 3, Revised Edition) (April 2017)
- Considerations for the Development of a Pharmaceutical Risk Management Plan (RMP) Based on the Utilization of Medical Professionals (March 2017)
- Japanese Translation of FDA's eCTD-related Notices (January 2017)
- Developing a Pharmaceutical Risk Management Plan: An Introduction (December 2016)
- Guide to Creating Electronic Common Technical Documents (eCTD) (Part 4, Revised) (October 2016)
- Guidance for the preparation of electronic Common Technical Documents (eCTD) (Version 4.1 English translation) (October 2016)
- Building an Effective Collaborative Framework between Pharmaceutical Companies and CROs: From an Outsourcing Relationship to a Mutually Trusted Partner (September 2016)
- Principles of Monitoring Operations (What they should be) (August 2016)
- Guide to the Creation of eCTD, Edition 4.2, Gateway-ready Edition (August 2016)
- Study on Benefit-Risk Assessment of Post-Marketing Drugs "From the Results of IMI-PROTECT" (July 2016)
- Japanese Translation of the EU module1 eCTD Specification (July 2016)
- Report on the Study of Efficient Feasibility Study Methods (June 2016)
- Manual for the Notification of "Medical Drug Attachments" (March 2016 edition) (March 2016)
- Points to Consider Regarding Electromagnetic Storage of Clinical Trial-Related Documents (March 2016)
- ICH M2 Recommendations (PDF/A and DOCX) (February 2016)
- Toward the Dissemination of ePRO (February 2016)
- Guide to the creation of eCTD (Version 4.1) (February 2016)
- Toward the Establishment of a Quality Management System Led by Medical Institutions (June 2015)
- Report on Clinical Trial Network Activation Activities (May 2015)
- Study on the preparation and utilization of the outline of the Risk Management Plan (RMP) for pharmaceuticals (May 2015) (May 2015)
- Study on the Appropriateness of Medical Institutional Costs in Clinical Trials (April 2015)
- Results of Questionnaire Survey on eCTD Compliance Status (March 2015)
- The Future of Clinical Research in a Changing World (2015)
- Establishment of Safety Considerations and Research Questions (Research Questions) for Scientific Drug Risk Management Plan (RMP) Practice (August 2014)
- Pharmaceutical Risk Management Plan Operating Procedure Model" (August 2014) (August 2014)
- A Guide to Developing a Pharmaceutical Risk Management Plan (RMP) (August 2014)
- Notes on Regulatory Revisions for Adverse Reaction Reports, Including Periodic Reports (Revised Version) (May 2014)
- Examination of Management Services in Healthcare Organizations (April 2014)
- Points to keep in mind to build and maintain a better collaborative relationship between pharmaceutical companies and contract research organizations (February 2014)
- RMP educational materials (August 2013)
- Survey 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)
- The sponsor's view on the use of joint IRBs, etc. (including central IRBs) (April 2012) (April 2012)
- Recommendations on Quality Control Processes for Efficient Implementation of Clinical Trials (April 2012)
- Tool for confirming files provided to companies regarding reports of adverse drug reactions from medical institutions to ETIC (for ETIC investigations) (February 2012)
- Detailed survey form (JPMA model) to be used for investigation of adverse drug reactions (February 2012) (February 2012)
- Explanation of the CDASH standard that defines data items for case report forms (December 2011)
- Role Sharing in Global Clinical Trials (May 2011)
- Proposal for a new trial cost calculation method based on the accumulation of work (March 2009)