Drug Evaluation Committee Search by Technical Subcommittee
Please refer to this page for PV-related Green Book, etc.
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(New Arrivals Order)
- Asian eCTD / Gateway System Information Publication (December 2025)
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Results of Questionnaire on Information Provision Activities at the Time of "Precautions for Use" Revision
-Trend of each company after the revision of the "KENSHU-AN" guidelines (December 2025) - A Review of the First 10 Years since the Introduction of the RMP System from the Pharmaceutical Industry's Perspective (December 2025)
- Publication of Presentation Material for eCTD v4 Implementation Promotion Symposium (November 28, 2025, Web Conference) (December 2025)
- Slide presentation "From the Pharmaceutical Industry - "How Do You Want Us to Utilize eCTD? Thoughts on Various Materials" (November 1, 2025, 19th Annual Meeting of the Japanese Society of Pharmacognosy) (December 2025)
- Preliminary Study on Application of AI to Quality Management of Clinical Trials - Aiming to Foster Quality Culture with AI as a Companion - (December 2025) (in Japanese) (December 2025)
- Data Linkage Initiative - Data Linkage from Overseas Regulations (Report on Phase 2 Activities) (November 2025)
- Guidance for Conducting Post-Marketing Database Surveys - November 2025 Edition - (November 2025) (November 2025)
- Evolution and Deepening of Data Management in Drug Development - Recommendations for Organizations and Human Resources 2025 - (November 2025) (November 2025)
- Slide presentation "Pharmaceutical Industry Initiatives to Promote Utilization of RMP/RMP Materials" (July 5, 2025, 27th Annual Meeting and Conference of the Japanese Society for Pharmaceutical Informatics) (November 2025)
- Survey of Examples of Utilization of Pharmaceutical Risk Management Plans (RMPs) and Preparation of a Collection of Examples of Utilization" (November 1, 2025, 19th Annual Meeting of the Japanese Society of Pharmacognosy, Presentation Slides) (November 2025) (in Japanese) (November 2025)
- Common Template for Explanatory and Consent Documents (ICF) (November 2025)
- Announcement of the release of eCTD v4 Creation Guide Version 1.0 (November 2025) (November, 2025)
- Guidance for Conformity Surveillance for Reexamination, etc. (October 2025)
- Q&A on Quality and Non-clinical Conformity Assessment (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)
- Survey and analysis of clinical data packages for approved items (October 2025)
- RMP training slides for MRs (revised August 2025) (October 2025)
- Lecture slides "Shaping the Thoughts of Pharmaceutical Companies: The Challenge of Delivering Appropriate Drug Information to Patients" (October 13, 2025, 58th Annual Meeting of the Japanese Pharmacists Association) (October 2025)
- Usage of Simulation in Bayesian Trial Design (October 2025)
- Survey Report on Drugs Designated under the Pioneering Examination and Designation System and the Pioneering Drug Designation System (October 2025)
- Scientific Discussion on FDA Review Report (September 2025)
- Tips for Signal Management Activities in Japan (August 2025)
- Results of Questionnaire on Creating and Sharing Clinical Trial Results (August 2025)
- PV:KT5 Pharmacovigilance Regulatory Survey Report Form (August 2025) (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)
- PV: KT1 RMP/RMP material utilization case studies - mainly for dispensing pharmacies - (July 2025) (in Japanese) (July 2025)
- Guidance for Efficient Preparation of Regulatory Documentation (CSR and CTD (Clinical Tables)) in Response to Changes in the Environment (July 2025)
- Slide presentation "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 Pharmaceutical Information Science) (July 2025)
- Slide presentation "Delivering the Latest Information Patients Need - From a Pharmaceutical Company's Perspective" at the 27th Annual Meeting of the Japanese Society for Drug Information Research, July 6, 2025. (July 2025)
- Do you know about the "drug use-results survey" conducted by pharmaceutical companies? (July 2025) (in Japanese)
- RMP Follow-up Survey on the Implementation Status of Post-Marketing Surveillance, etc. (1st interim results) (July 2025) (July 2025)
- Guidance on the Preparation of Defect Reports for Drug Combination Products (2025 Edition) (July 2025) (in Japanese) (July 2025)
- Checklist and Q&A_ver.1 for Self-Inspection for Non-Clinical Studies (English version) (July 2025) (July 2025)
- Evaluation of Validation Necessary 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)
- Dawn of the ICH E6 (R3) Era: The Future of Clinical Data Manager - Summary of Relevant Parts of CDM (June 2025)
- Generating AI and other digital technologies: A guide for medical writers to prepare pharmaceutical documents in response to changes in the environment of 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 RWD and RWE Utilization (May 2025)
-
Digital Therapeutics (DTx) in Japan
-Comparison with German and U.S. systems (May 2025) - Reference Document on Clinical Development of Regenerative Medicine Products (May 2025)
- Handbook on Regulatory Requirements and Publications of Electronic Information (May 2025)
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Utilization of Patient Experience Information for Patient-Focused Drug Development
-For Decision-Making Based on the Voice of the Patient- (April 2025) (in Japanese) (April 2025) - Model Credibility Assessment in Drug Development (April 2025) Patient-Reported Outcomes in Clinical Trials
- 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 Protocol (CeSHarP)" Questionnaire Results for Domestic Implementation (FY2024) (March 2025)
- Guidance for preparation of "Periodic Report of Infectious Diseases" (Revised edition, 2025) (March 2025)
- Leaflet: What is Medical Affairs (MA) for pharmaceutical companies? (March 2025)
- How to proceed with a post-marketing database study using a registry - February 2025 edition - (March 2025)
- Simulation Considerations for Planning Adaptive Designs (Feb 2025)
- Considerations for Conducting Indirect Comparisons in Cost-Effectiveness Assessments (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 (Feb. 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) (January 2025)
- Consideration of Pseudonym Processing Techniques when Creating 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 Pharmaceutical Sciences (Dec. 2024)
- Translation: FDA Guidance related to RWD (November 2024)
- ICH E19 "Selective Approach to Safety Data Collection in Certain Clinical Trials Conducted after Approval or Approval in the Late Phase of Development" Points to Consider in Conducting Applicable Trials - Mainly from the Perspective of Data Management (November 2024)
- eCTD v4.0 Educational Materials Version 2 is now available. (November 2024)
- Transparency checklist for de-identified/anonymized data sharing -From the checklist created by TransCelerate (November 2024)
- Guidance on Procedures for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Commentary on "Q&A on Investigations of Usage Results for Ethical Drugs Using the All Patient Surveillance Method (October 2024)
- Questionnaire on the status of introduction of DCT and the results of each DCT method (October 2024)
- Approaches to QMS Implementation by Clinical Trial Sponsors - Fostering a Culture of Quality and Demonstrating Leadership (September 2024)
- How to Find Clinical Trials - jRCT Mikata - 3rd Edition (April 2025)
- Survey on Patients' and Families' Access to Drug Information - Preliminary Report - (February 2024) (July 2024)
- Overview of FDA CSA Draft Guidance and Discussion and Consideration of its Application to the GxP Area (July 2024)
- Overview and Key Points of the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects (July 2024)
- Questionnaire Report on the Current Status of Post-Marketing DB Surveillance (Feasibility Study/Reliability Confirmation) (July 2024) (in Japanese) (July 2024)
- Prototype Model for Investigation of AI Utilization in Data Management Operations (June 2024) Model prototype for studying the use of AI in data management operations (June 2024)
- Explanation of the RMP Mark (Revised 2024) (June 2024)
- Issues and Causal Analysis of Health Communication between Patients/Citizens and Pharmaceutical Companies (June 2024)
- Causal Reasoning for Interpretation - Causal Mediation Analysis, ed. (June 2024)
- Communicating Clinical Trial Information in an Easy-to-Understand Way For Pharmaceutical Companies Creating Documents for Non-Professionals. (Jun 2024)
- Challenges in pharmaceutical documentation and proposals for the use 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 Exemption from Electronic Data Submission" and "Information Sharing on SDTMIG v3.3 and Define-XML v2.1" (June 2024) (June 2024)
- Introduction of case studies on the use of open source software (June 2024)
- Utilization of Medical Information DB (June 2024)
- Recommendations on Safety Data Collection and Reporting (May 2024)
- Promotion of consistent quality management as clinical trials (May 2024) (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)
- Complex Innovative Trial Design: Current Status and Case Studies (May 2024) (April 2024)
- Report on the Results of the Questionnaire on Patient Involvement in Clinical Trials (April 2024) (in Japanese) (April 2024)
- Efficient CSV Documentation Using Vendor Materials (April 2024) (Apr 2024)
- Educational and Training Materials for E2B(R3) Commentary (Apr 2024)
- Introduction to the use of Single Sign-On (SSO) for the current status of account management for clinical trial related IT systems (April 2024)
- Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 version) (April 2024)
- Common master (medical institution-related information) for utilization of clinical trial-related systems (April 2024) (April 2024)
- Guidance for Remote Investigation (Reexamination) Ver3.0 (March 2024) (April 2024) (April 2024)
- Glossary of Health and Medical Data (April 2024)
- Guidance for Preparation of "Electronic Attachments of Ethical Drugs" (Revised version, April 2024) (April 2024)
- Guidance for Reexamination Application -Gateway System Use- (March 2024) (March 2024)
- Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (Revised edition, March 2024) (March 2024)
- Q&A on "Registration of Clinical Trials" (No. 9 of 0831 issued by the Pharmaceutical Affairs Agency on August 31, 2020) (4th Edition) (February 2024) (February 2024)
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Guidance for providing information on "electronic package inserts of ethical drugs" (February 2024 edition)
(February 2024) - Electronic Detailed Questionnaire for Adverse Event Surveillance (Pharmaceutical Cooperative Electronic Model) (February 2024)
- How to Find a Clinical Trial - jRCT Mikata" Educational Material (April 2025)
- Results of Questionnaire on Electronic Provision of Information - Trends in Pharmaceutical Cooperative Participating Companies (conducted in January 2023) (January 2024)
- Guidance for Conducting Post-Marketing Database Surveys -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 for Reexamination, etc. (December 2023)
- Quality Control - Fraud Detection and Prevention （Quality Control - Fraud Detection Prevention (December 2023)
- Introduction to "Collection and Management of Safety Data in Clinical Trials" from CIOMS Working Group VI Report, Chapter 4 (December 2023) (December 2023)
- Quality Control in Drug Development -Examination of 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) (December 2023)
- Survey to Understand the Needs of Healthcare Professionals Concerning Safety Information of Drugs (Physicians and Pharmacists) -Preliminary Report- (May 2023) (December 2023)
- Pharmaceutical Risk Management Plan (RMP) Comparative Study on the Status of Formulation of Additional Risk Minimization Activities in Japan, the U.S. and Europe (November 2023)
- Results of a survey on the provision of information to patients using digital technology (conducted by companies participating in the PV Subcommittee, January-February 2023) (October 2023)
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List of items to be enrolled in studies transitioning from JapicCTI Initial version
Comparative Table of jRCT-JapicCTI Registration Items, 2nd ed. (October 2023) - Survey of Model-Informed Drug Development through Research on Approved Drugs in Japan (October 2023)
- Data Linkage Initiative: Recommendations from the Field of Medicine and Clinical Trials (August 2023) (August 2023)
- Paper on eConsent Practices and Strategies to Solve Issues (August 2023) (August 2023)
- Points to be Noted in Regulatory Revisions Concerning the Handling of Safety Information on Investigational Products in Clinical Trials (August 2023) (in Japanese) (August 2023)
- Composition of CTD using results of global clinical trials based on the principles of ICH E17 (August 2023) (August 2023)
- Guidance for Notification of "Electronic Attachments of Ethical Drugs" (August 2023) (August 2023)
- Ensuring Effective and Efficient Quality in 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 Trials_ver.1 (July 2023)
- Flexible Survival Time Modeling Methods and Extrapolation of Survival Time 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 medical records 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 for the Future
～Focusing on Vendor Oversight, QMS, and DCT (May 2023) (May 2023) - Utilization of Artificial Intelligence in Data Management - Starting with AI - (May 2023) (May 2023)
- Multivariate Meta-Analysis and Alternative Endpoints in Medical 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 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 Medical Data and Our Lives (April 2023)
- Checklist for Voluntary Inspection for Non-clinical Studies_ver.1 (March 2023)
- Implementation of Estimand into Clinical Trial Protocols (March 2023)
- Considerations for Cost-Effectiveness Evaluation Learned from Case Studies (March 2023)
- eCTD v4.0 Educational Materials (March 2023)
- Basic Concepts on Safety Forms for Clinical Trials (February 2023)
- A Study on Statistical Inference for Adaptive Design (February 2023)
- Results of a Questionnaire Survey of Pharmaceutical Companies on the Current Status of Clinical Trials (January 2023)
- Guidance for Preparation of a Drug Risk Management Plan (J-RMP) -January 2023 Edition- (January 2023) (January 2023)
- Internal Process Flow for Utilizing the Registry for Drug Applications (From Internal Proposal to Registry Modification) (December 2022) (December 2022)
- Guidance on "Provision of Medical and Scientific Information" by the Medical Affairs Division (December 2022) (December 2022)
- Direction of Medical Education Meetings (December 2022) (December 2022)
- How to Estimate the Effectiveness of Rare Disease Treatments (December 2022) (December 2022)
- Guidance for Preparation of "Post-marketing Surveillance Protocol" and "Post-marketing Surveillance Report" (revised edition, 2022) (December 2022) (December 2022)
- Issues to be resolved to promote the sharing of clinical trial data (December 2022)
- Introduction of Sequential Multiple Assignment Randomized Trials (SMART) (November 2022) (November 2022)
- The Future of Clinical Research in a Changing World (October 2022)
- Current Status and Challenges of DDC/EHR Data Linkage (September 2022)
- Guidance for Electronic Reporting of Adverse Reactions and Infectious Drug Reactions -E2B(R3)- (September 2022) (September 2022)
- Causal Inference 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)
- Future Drug Evaluation - What is the Significance of Japanese Data in International Joint Development? -Dr. (July 2022)
- Causal Inference for Understanding ICH E9(R1) (July 2022)
- Directions for MSL (July 2022)
- Considerations for Using Real World Data as an External Control for Regulatory Applications (July 2022)
- Examination of Issues for Ensuring Reliability of Post-Marketing Database Surveys (June 2022) (June 2022)
- Let's learn about "Pharmaceuticals" and "Clinical Trials"! (audio description) (April 2022) (April 2022)
- Guidance for Preparation of Electronic Attachments of Ethical Drugs -Corresponding to the Guidelines for Description in 2009 and 2021- (April 2022 edition) (in Japanese) (April 2022)
- Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials), 2nd ed. (April 2022)
- Pharmaceutical Association of Japan Recommended Form for Communicating Safety Information to Clinical Research Organizations (April 2022)
- Hints for Introduction and Utilization of Quality Management System in PV (April 2022) (in Japanese) (April 2022)
- Study to promote utilization of the registry for pediatric, rare 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 Issues of eConsent in Drug Development (April 2022)
- Requirements for Digitization of Paper Originals of Clinical Trial Documents (Focusing on Certified Copy Operation) (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)
- Explanatory material on basic matters for utilizing eTMF (electronic Trial Master File) and TMF Metrics (March 2022)
- Guidebook for Pharmaceutical Companies to Implement Patient Centricity-based Activities (March 2022) (March 2022)
- Maintenance of J-RMP as Seen from Company Case Studies - Proposals for Appropriate Pharmaceutical Risk Management (March 2022 edition) (March 2022) (in Japanese)
- Current Status and Points to Keep in Mind for Introducing RPA into PV Operations (February 2022)
- Slide collection of explanations on 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 for Indirect Comparisons? (January 2022)
- Guidance for Remote Investigation (Reexamination) (May 2023) (May 2023)
- Toward the Realization of Appropriate Clinical Trial Costs in Japan (Audio Commentary) (December 2021) (in Japanese)
- Introduction and modeling of NICE TSD (November 2021) (in Japanese)
- Guidance for Reexamination Application (October 2021)
- NICE TSD introduction and QOL values (October 2021)
- Guidance for Periodic Safety Reporting (September 2021)
- Manual for Notification of "Electronic Attachments of Ethical Drugs" (August 2021 edition) (August 2021)
- Japanese Translation of FDA Guidance on Adaptive Design (August 2021) (in Japanese)
- 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)
- Start Today! Process Management of Clinical Trials Conducted at Medical Institutions (July 2021)
- Q&A on Conducting Medical Education Meetings and Medical Booths (July 2021)
- Pharmaceutical Risk Management Plan (RMP) Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) (June 2021)
- Guidance for Preparation of Defect Reports Related to Combination Products that are Medicinal Products (2021 Edition) (June 2021)
- Innovative Changes in Data Management (June 2021)
- Guidance for Providing Information on "Electronic Attachments of Ethical Drugs" (May 2021) (May 2021)
- Study 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 for Preparation of a Drug Risk Management Plan (J-RMP) (May 2021) (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 FY2020 Revision of Notification on Reexamination, Periodic Safety Reporting, and Conformity Surveillance (March 2021)
- 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) (February 2021) (February 2021)
- Central Monitoring (December 2020)
- Points to keep in mind when conducting post-marketing database surveillance of pharmaceuticals using medical information databases, etc. (December 2020) (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)
- Data Collection Considerations in Post-Marketing Surveillance (October 2020)
- The Future of Clinical Research in a Changing World (October 2020)
- Consideration for the introduction and utilization of clinical trial methods that do not depend on visits to medical institutions (September 2020) (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 status and future challenges of multiplicity issues in clinical trials (June 2020)
-
In the Era of Internationalization of Drug Development
Study on the handling of safety information during clinical trials in the era of internationalization of drug development (June 2020) (June 2020) - What is Blockchain? (June 2020)
- Considering the Ecosystem of Disease Registries (June 2020)
- Guidance for Drug Interview Forms (Revised) (May 2020) (May 2020)
- Machine Learning Started. (May 2020)
- Toward the Study of Establishing a Safety Surveillance Plan in accordance with "How to Proceed with the Study of Establishing a Plan for Conducting Post-Marketing Surveillance of Drugs" (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) (April 2020)
- Overview of eSource (DDC and EHR) and points to keep in mind when implementing eSource (April 2020) (April 2020)
- Streamlining computerized system validation in the GCP area (March 2020)
- Manual for Notification of "Attachments to Ethical Drugs" (March 2020 edition) （Trial Master File Reference Model Ver3.0 (March 2020)
- Mapping list of documents related to clinical trials 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) "Checklist for GPSP Conformity Surveillance of Pharmaceuticals" (March 2020)
- Basic Approach to Electronic Regulatory Compliance, including "Use of Electromagnetic Records and Electronic Signatures for Applications for Approval or Licensing of Pharmaceuticals, etc." (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 the J-RMP as Seen in 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)
- Layout of analysis forms for summary reports and examples of ADaM data to be used. (December 2019)
- Network meta-analysis overview and notes (November 2019)
- Additional Risk Minimization Activity Development Considerations for Drug Risk Management Plans (RMPs) (October 2019)
- For Sharing Individual Participant/Patient Data (IPD) from Clinical Trials (October 2019)
- Drug Development with the Voice of the Patient. (September 2019)
- Pharmaceutical Manufacturers Association 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 of Disease Registries in Drug Development (June 2019)
- Guide to the Creation of Electronic Files of Attachment Information for Ethical Drugs - XML Format - Tentative 1st edition published. (May 2019)
- What is AI? (May 2019)
- Manual for Notification of "Attachments to Ethical Drugs" (May 2027 edition) (May 2019)
- How far can existing domestic real-world data be used 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)
- Guidance for Creating XML Files for Clinical Trial Notification (3rd Edition) (March 2019)
- Guidance for Preparation of Commentary on "Precautions for Use" for New Drugs (March 2019)
- Metrics for Evaluating Survival-Time-Type Responses (2nd ed.) (March 2019)
- RMP Training Slides for MRs and RMP Explanation Slides by MRs (Slide Template for RMP Explanation for Medical Institutions) (March 2019)
- New Guidelines for the Description of Ethical Drug Attachments Explanatory Material" (February 2019) (February 2019)
- Guidance for Preparation of Drug Interview Forms (Revised Version), Revised November 2018 (Provisional Version) (November 2018)
- How Medical Institutions Should Focus on Changes in the Clinical Trial Environment (September 2018)
- Collection of Examples of Post-Marketing Database Investigation Implementation Plans (August 2018)
- ICH E6(R2) Training Materials." (July 2018)
- Establishing a Performance-Based Clinical Trial Fee Payment Method 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)
- A Guide to Implementing a Regulatory Information Management System (RIMS) (February 2018)
- Report on the Analysis of the Current State of Clinical Trial Networks and the Results of a Study for Their Future Development (August 2017)
- Guidance for Creating 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 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)
- Guide to Creating Electronic Common Technical Documents (eCTD) (Part 4, Revised) (October 2016)
- Guide to Preparing Electronic Common Technical Documents (eCTD) (Edition 4.1 English Translation) (October 2016)
- Building Effective Collaboration between Pharmaceutical Companies and CROs: From a Contract Relationship to a Mutually Trusted Partner (September 2016) (September 2016)
- Principles for Monitoring Operations (August 2016) (August 2016)
- Guide to eCTD Preparation, Edition 4.2 Gateway-compliant Edition (August 2016)
- Survey 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 Methodology (June 2016)
- Manual for Notification of "Attachments to Medical Products for Human Use" (March 2016 edition) (March 2016)
- Points to keep in mind regarding the 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 eCTD Creation (Version 4.1) (February 2016)
- Toward the establishment of a medical institution-led quality management system (June 2015)
- Report on Clinical Trial Network Activation Activities (May 2015)
- Outline of the Pharmaceutical Risk Management Plan (RMP) Study on Preparation and Utilization of the RMP (May 2015) (May 2015)
- Study on Optimization of Medical Institutional Costs for Clinical Trials (April 2015)
- Results of Questionnaire Survey on eCTD Compliance Status (March 2015)
- Considering the Future of Clinical Research in the Face of Change (2015)
- Establishment of Safety Considerations and Research Questions (Research Questions) for Scientific Drug Risk Management Plan (RMP) Practice (August 2014)
- The Drug Risk Management Plan Operating Procedure Model. (August 2014)
- Guidance for Developing a Drug Risk Management Plan (RMP) (August 2014)
- Notes on Regulatory Revisions for Adverse Reaction Reporting, Including Periodic Reporting (Revised) (May 2014)
- Review of management tasks in medical institutions (April 2014)
- Considerations for Establishing and Maintaining Better Collaborative Relationships between Pharmaceutical Companies and Contract Research Organizations (February 2014)
- RMP awareness-raising materials (August 2013)
- Survey on the Current State 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) (March 2013)
- 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) (April 2012)
- Tool for checking 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 (Pharmaceutical Cooperative Model) (February 2012)
- Explanation of the CDASH standard that defines data items for case report forms (December 2011) (December 2011)
- Role sharing in global clinical trials (May, 2011) (May 2011)
- Proposal for a New Clinical Trial Cost Calculation Method Based on Accumulated Work (March 2009) (March 2009)
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