Drug Evaluation Committee All Deliverables of the Drug Evaluation Committee
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(New arrivals first)
- Theory and Practice of Model-based Meta Analysis in Drug Development （Theory and Practice of Model-based Meta Analysis in Drug Development (May 2026)
- Explanation of "Handling of Provision of Information for Clinical Trials, etc." and Q&A (May 2026)
- Current status of post-marketing surveillance under the Japanese GPSP ordinance: Questionnaire survey on GPSP (May 2026)
- Survey and compilation of regulations and actual utilization of clinical trials that do not rely on visits to medical institutions (May 2026)
- Digital Applications in Preventive Medicine and Pharmaceutical Companies' Initiatives (May 2026)
- ICH-E6 (R3) Awareness Video (May 2026)
- Research and Consideration on Data Utilization for jRCT and Clinical Trial Notification for ICH M11 Implementation (May 2026)
- The Dawn of the ICH E6(R3) Era: The Future of Clinical Data Managers - How will the work of Clinical Data Managers change with the identification of CTQ factors? (May 2026)
- Communication of Drug Information that Generates Satisfaction - Toward the Construction of "Satisfaction" and "Trust" Based on Scientific Evidence (April 2026) (April 2026)
- Held a workshop on "People x Technology x Future - Our Vision for the Next Generation of Pharmacovigilance (April 2026)
- Guidance on the preparation of the "Infectious Disease Evaluation Report" (2026 edition) (April 2026)
- Positioning map analysis of patients when searching for drug information on the Web (April 2026)
- A Beginner's Guide to the Use of NDB in the Pharmaceutical Industry (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 version) (April 2026)
- Don't take medical and health information for granted! Educational materials (collaboration of three organizations) (April 2026)
- Handbook for Regulatory Requirements and Publications of Digitized Information (April 2026)
- Contribution of Clinical Pharmacology to Ensuring Diversity in Drug Development - Toward Closing the Gap in Patient Backgrounds 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 FDA's "Risk-Based Credibility Assessment of AI Models" Framework (April 2026)
- Results of Fixed-point Survey of Patient and Public Involvement Activities in Drug Development by Pharmaceutical Companies (March 2026)
- Systematic survey on RWD/RWE - Approaches to issues using innovative technologies and examples of FDA regulatory filings - (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 Self-inspection for 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 briefing session on the detailed survey form (JPMA electronic model) used in adverse drug reaction investigations (March 2026) (March 2026)
- Database Research in Medical Affairs: A Comprehensive Analysis Using Questionnaire and Paper Surveys (2025 Survey) (March 2026)
- Toward the Use of Wearable Devices Publication (March 2026)
- Information and background required for companies to utilize 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 Enhance Drug Discovery Capability and Ensure Stable Supplies, etc." as revealed through the results of a 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)
- Research 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)
- 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 Release (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 Conference) (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 AI Application to Clinical Trial Quality Management - Aiming to Foster Quality Culture with AI as a Companion - (December 2025) (in Japanese) (December 2025)
- Data Linkage Initiative - Data Linkage from the Perspective of Overseas Regulations (2nd periodic activity report) (November 2025) (November 2025)
- Guidance for conducting post-marketing database survey -November 2025 edition- (November 2025) (November 2025)
- Evolution and Advancement of Data Management in Drug Development(Executive Summary) (November 2025)
- Slide presentation "Efforts of the Pharmaceutical Industry to Promote Utilization of RMP/RMP Materials" (July 5, 2025, 27th Assembly and Annual Meeting of the Japanese Society for Pharmaceutical 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)
- Notice of Release of eCTD v4 Preparation Guide Version 1.0 (November 2025) (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 Study Design (October 2025)
- Investigation Reports for Drugs Designated under the Pioneer Review Designation System and the Pioneer Drug Designation System (October 2025) (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, "Providing Adverse Reaction Information: How to Provide Information for the Next Generation" (July 25, 2025, 16th Annual Meeting of the Japanese Society of Pharmaceutical Medicine) (August 2025)
- JPMA Web site release] PV: KT1 Case studies of the use of RMP/RMP materials - mainly for dispensing pharmacies (July 2025)
- Guidance for efficient preparation of regulatory documents (CSR and CTD (clinical part)) 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 "Use-results Surveys" 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 on preparing defect reports for combination products that are drugs (2025 edition) (July 2025)
- Checklist and Q&A for Non-clinical Studies_ver.1 in English (July 2025) (July 2025)
- Evaluation of the Validation Required for the Use of Digital Biomarkers as Primary Endpoints in Clinical Trials (July 2025)
- Covariate Adjustment of 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 Relevant Parts of CDM. (June 2025)
- Guidance on pharmaceutical documentation for medical writers in response to changes in the environment of digital technology such as generation AI (June 2025)
- Comparison of guidance related to RWD/RWE utilization in Japan and the U.S. (May 2025)
- Report of the Roundtable on Prioritization of Issues for 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 Guide for Clinical Development of Regenerative Medicine Products (May 2025)
- Handbook of Regulatory Requirements and Publications for Electronic Information (May 2025)
- Utilization of Patient Experience Information for Patient-Focused Drug Development
Using Patient Experience Information for Patient-Focused Drug Development - For Decision-Making Based on the Voice of the Patient - (April 2025) (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 Study Protocol (CeSHarP)" Questionnaire Results for Domestic Implementation (2024) (March 2025)
- Guidance on the preparation of the "Periodic Report of Infectious Diseases" (Revised edition, 2025) (March 2025) (March 2025)
- Leaflet: What is Medical Affairs (MA) for Pharmaceutical Companies? (March 2025)
- How to Proceed with Post-Marketing Database Investigations 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 a 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 Pseudonym Processing Techniques when Preparing Pseudonym Processed 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 Biomedical Pharmacology and Pharmacognosy (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) (October 2024)
- Questionnaire on the status of DCT implementation and the results of each DCT method (October 2024)
- Approaches to QMS Implementation for Clinical Trial Sponsors - Fostering a Culture of Quality and Demonstrating Leadership (September 2024)
- How to Find Clinical Trials - jRCTs - 3rd Edition (April 2025)
- Survey on Patients' and Families' Access to Drug Information - Preliminary Report (conducted in February 2024) (July 2024)
- Overview of FDA CSA Draft Guidance and Consideration and Discussion of Application to GxP Areas (July 2024)
- Summary and Key Points of 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)
- Model prototyping to study 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 Mediation Analysis Edition (June 2024)
- For pharmaceutical companies creating documents for non-specialists to communicate information on clinical trials in an easy-to-understand manner. (June 2024)
- Challenges of Pharmaceutical Documentation and Proposals for Utilization of Digital Technology Toward Society 5.0 (Data Society) (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)
- Case Studies of Open Source Software (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 clinical trials (May 2024)
- Medical Device Program (SaMD) Development Overview (May 2024)
- Current Status and Potential of Digital Transformation (DX) in Clinical Development (May 2024)
- Guidance for "Periodic Safety Reporting" -Gateway System Use- (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)
- Current Status of Complex Innovative Trial Design and Case Studies with Japanese Translation of FDA Guidance (April 2024) (April 2024)
- Report on Results of Questionnaire on Patient Involvement in Clinical Trials (April 2024)
- Efficient CSV documentation using vendor materials (April 2024)
- Education and Training Materials for the E2B(R3) Explanation (April 2024)
- Introduction to the Use of Single Sign-On (SSO) for the Current State of Account Management of Clinical Trial-Related IT Systems (April 2024)
- Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (2024 Edition) (April 2026) (April 2024) (April 2026)
- Common master (medical institution-related information) with a view to utilizing clinical trial-related systems (April 2024)
- Guidance for Remote Investigation (Reexamination) Ver 3.0 (Prepared in 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)
- Guide to Application for Reexamination - Gateway System (March 2024)
- Guidance for Preparation of "Post-Marketing Surveillance Protocol" and "Post-Marketing Surveillance Report" (Revised 2024) (March 2024)
- Q&As on "Registration of Clinical Trials" (No. 9 of 0831 issued by the Pharmaceutical Affairs Agency, August 31, 2020) (February 2024) (February 2024)
- Guidance for Providing Information on "Electronic Attachments of Ethical Drugs" (February 2024 Edition)
(February 2024) - Electronic Detailed Questionnaire for Adverse Event Surveillance (JPMA electronic model) (February 2024) (February 2024)
- How to Find Clinical Trials - 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 Reexamination (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 Way 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 Status of Development of Additional Risk Minimization Activities in Japan, the U.S., and Europe (November 2023) (November 2023)
- Results of Questionnaire on Information Provision to Patients Using Digital Technology (PV Subcommittee Participating Companies, January-February 2023) (October 2023)
- List of registration items for studies transitioning from JapicCTI Initial version
Comparative Table of jRCT-JapicCTI Registration Items, 2nd ed. (October 2023) - Investigation of the actual status of Model-Informed Drug Development through a survey on approved products in Japan (October 2023)
- Data Linkage Concept: Recommendations from the Field of Medicine and Clinical Trials (August 2023) (August 2023)
- Paper on eConsent Practice and Measures to Solve Problems (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 Attachments 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 Time Using External Information (June 2023)
- Recent Cancer Phase I Study 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 on the Current Status 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) - Utilization 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 keep in mind regarding the protection of personal information in drug development and secondary use of data" (April 2023) (April 2023)
- Utilization of Open Source Software and Points to Consider" and "OSS Utilization Status Questionnaire Report" (April 2023) (April 2023)
- Health Care Data and Our Lives (April 2023)
- Checklist for Voluntary Inspection for Non-clinical Trials_ver.1 (March 2023)
- Implementation of Estimand into Clinical Trial Protocols (March 2023)
- Considerations for Cost-Effectiveness Assessment from Case Studies (March 2023)
- eCTD v4.0 Educational Materials (March 2023)
- Basic Approach to Safety Forms for Clinical Trials (February 2023)
- Study on statistical inference for adaptive design (February 2023)
- Results of the Questionnaire Survey on the Current Status of Clinical Trials for Pharmaceutical Companies (January 2023)
- Guidance for Preparation of Drug Risk Management Plan (J-RMP) -January 2023 Edition- (January 2023) (January 2023)
- Internal process flow when 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 Department (December 2022)
- Directions for Medical Education Meeting (December 2022)
- Estimation of Therapeutic Effectiveness for Rare Diseases (December 2022)
- Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (revised edition in 2022) (December 2022) (December 2022)
- Issues to be resolved to promote sharing of clinical trial data (December 2022)
- Sequential Multiple Assignment Randomized Trials (SMART) (November 2022)
- The Future of Clinical Research in a Changing World (October 2022)
- Current Status and Issues of DDC/EHR Data Linkage (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 an external control for pharmaceutical applications (July 2022)
- Examination of issues to ensure the reliability of post-marketing database surveys (June 2022) (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)
- Consideration for promotion of utilization of the Registry for Pediatric, Rare and Intractable Diseases (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)
- Requirements for Digitization of Paper Originals of Clinical Trial Documents (Focusing on the Operation of Certified Copy) (April 2022)
- Results of Questionnaire on Remote Surveillance (Conformity Surveillance 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 Activities Based on Patient Centricity (2022 Edition) (March 2022)
- Maintenance of the J-RMP as Seen from Company Case Studies - Proposals for Appropriate Drug Risk Management (March 2022 edition) (March 2022) (March 2022)
- Current Status and Considerations for Introducing RPA into PV Operations (February 2022)
- Slide collection explaining how to introduce and utilize clinical trial methods that do not depend on visits to medical institutions. (January 2022)
- Is the population adjustment method useful in indirect comparisons? (January 2022)
- Guidance for remote survey (reexamination) (May 2023) (May 2023)
- Toward the Realization of Appropriate 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 referral and quality of life values (October 2021)
- Guidance for Periodic Safety Reporting (September 2021)
- Manual for Notification of Electronic Drug Information for Prescription Drugs (August 2021 edition) (August 2021) (August 2021)
- Japanese Translation of the FDA Guidance on Adaptive Design (August 2021)
- Study on the use of clinical trial methods that do not depend on visits to medical institutions - a guide for introduction in Japan - (August 2021) (August 2021)
- Get Started Today! Process Management for Clinical Trials Conducted at Healthcare Organizations (July 2021)
- Q&A on Medical Education Meetings and Medical Booths (July 2021) (July 2021)
- Pharmaceutical Risk Management Plan (RMP) Notes for evaluating the effectiveness of additional risk minimization activities (materials) (June 2021)
- Guidance for reporting defects in pharmaceutical combination products (2021 edition) (June 2021) (June 2021)
- Innovative Changes in Data Management (June 2021)
- Guidance for providing information on "electronic drug inserts for ethical drugs" (May 2021) (May 2021)
- Study on Study Design and Statistical Evaluation Methods in the Development of Regenerative Medicine Products (June 2024) (May 2021)
- Drug Development Using Real World Data and Disease Registries (May 2021)
- Guidance for Preparation of Pharmaceutical 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 Amendments to the Notification Concerning Reexamination, Periodic Safety Reporting and Conformity Surveillance in FY2020 (March 2021) (in Japanese) (March 2021) (in Japanese)
- Examination of 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)
- Guidance for Creating XML Files for Clinical Trial Notification (4th Edition) (February 2021)
- Central Monitoring (December 2020)
- Notes on the Implementation of Post-Marketing Database Surveillance of 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 keep in mind when collecting data in post-marketing use-results surveys (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) (June 2020)
- Current status and future issues of multiplicity issues in clinical trials (June 2020)
- In the Era of Internationalization of Drug Development
Study on Handling of Safety Information during Clinical Trials (June 2020) - What is Blockchain? (June 2020)
- Considering the Ecosystem of Disease Registries (June 2020)
- Guidance for Preparation of Interview Forms for Pharmaceutical Products (Revised Edition) (May 2020) (May 2020)
- Machine learning started. (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)
- Regulatory and Response Considerations Related to Clinical Trial Data Sharing (CTDS) (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 the Notification of "Medical Product Attachments" (March 2020 edition) (March 2020)
- Mapping List of Clinical Trial Documents in Japan to Trial Master File Reference Model Ver3.0 (March 2020) (March 2020)
- Checklist for GPSP Conformity Surveillance of Pharmaceuticals" (March 2020) (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 Assessment (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)
- 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 with the Voice of the Patient (September 2019)
- JPMA Q&A on the "Clinical Research Act and Enforcement Regulations of the Clinical Research Act" (August 2019)
- Literature review related to Estimand and sensitivity analysis in clinical trials (June 2019)
- Current Analysis and Prospects of 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)
- How far existing domestic real-world data can be utilized for drug development (May 2019)
- Toward Reasonable Clinical Trial Costs in Japan (May 2019)
- Recommendations for Sensitivity Analysis in Observational Studies Practice (April 2019)
- The Future of Clinical Research in a Changing World (April 2019)
- 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)
- Evaluation Metrics for Survival Time-Type Responses (Version 2) (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 Healthcare Organizations Should Focus on the Changing Environment of Clinical Trials (September 2018)
- A collection of examples of post-marketing database survey implementation plans (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 Challenges of IoT Utilization in Drug Development (March 2018)
- Guidance on the implementation of Regulatory Information Management System (RIMS) (February 2018)
- Report on the Analysis of the Current Status of Clinical Trial Networks and the Results of Studies for Their Future Development (August 2017)
- Guidance for the preparation of electronic Common Technical Documents (eCTD) (Part 1, Revised Edition) (April 2017)
- Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Part 3, Revised Edition) (April 2017)
- Considerations for Developing a Pharmaceutical Risk Management Plan (RMP) Based on Utilization by Healthcare Professionals (March 2017)
- Japanese Translation of FDA's eCTD-related Notices (January 2017)
- Developing a Drug Risk Management Plan: An Introduction (December 2016)
- Guidance for the preparation of electronic Common Technical Documents (eCTD) (Part 4, Revised Edition) (October 2016)
- Guidance for Creating Electronic Common Technical Documents (eCTD) (Version 4.1 English translation) (October 2016)
- Building an Effective Collaborative Structure between Pharmaceutical Companies and CROs: From an Outsourcing Relationship to a Trusted Partner (September 2016)
- Principles of Monitoring Operations (What they should be) (August 2016)
- Guide to eCTD Preparation, Edition 4.2, Gateway-compliant 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 Investigation of Efficient Feasibility Study Methods (June 2016)
- Manual for Notification of "Medical Drug Attachments" (March 2016 edition) (March 2016)
- Considerations for Electromagnetic Storage of Clinical Trial Documents (March 2016)
- ICH M2 Recommendations (PDF/A and DOCX) (February 2016)
- Toward the Dissemination of ePRO (February 2016)
- Guide to eCTD creation (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)
- Outline of the Pharmaceutical Risk Management Plan (RMP) A study on the preparation and utilization of the RMP (May 2015)
- Study on the Appropriateness of Medical Institutional Costs in Clinical Trials (April 2015)
- Results of a survey on the status of eCTD support (March 2015)
- The Future of Clinical Research in a Changing World (2015)
- Establishing Safety Considerations and Research Questions (Research Questions) for Scientific Drug Risk Management Plan (RMP) Practice (August 2014)
- The Pharmaceutical Risk Management Plan Operating Procedure Model (August 2014)
- A Guide to Developing a Pharmaceutical Risk Management Plan (RMP) (August 2014)
- Notes on Regulatory Revisions for Adverse Reaction Reporting, Including Periodic Reporting (Revised) (May 2014)
- Examination of Management Services at Medical Institutions (April 2014)
- Points to keep in mind to build and maintain a better collaborative relationship between pharmaceutical companies and contract research organizations (February 2014) (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 Clinical Trial Environment in Japan and Consideration of Areas for Improvement (March 2013)
- Sponsor's idea 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 adverse drug reaction reports from medical institutions to ETIC (for ETIC investigations) (February 2012)
- Detailed Questionnaire for Adverse Reaction Surveillance (JPMA Model) (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 clinical trial cost calculation method based on the accumulation of work (March 2009)