Drug Evaluation Committee Search by category
Please refer to the PV-related Green Book and other publications from this page.
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- General
(New arrivals first)
- Information and Background for Companies to Utilize Disease Registries (March 2026)
- Report on Communication Challenges in Introducing DCT - Communication and Risk Minimization Approaches 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 Supplies, etc." as revealed through the results of the survey in the pharmaceutical industry (February 2026)
- Publication of "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 Utilization of Medical Databases in Regular Safety Monitoring Activities"" (February 2026) (February 2026)
- Survey and Analysis of Clinical Data Packages for Approved Products (January 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)
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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 Disclosure Notice (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 "KENSENSHU GUIDELINES" (December, 2025) (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 Assembly 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 "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)
- Survey of Examples of Utilization of Pharmaceutical Risk Management Plans (RMPs) and Preparation of a Collection of Examples of Utilization" (November 1, 2025, 19th Assembly of the Japanese Society of Pharmacy) (November 2025) (in Japanese) (Presentation slides) (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)
- RMP training slides for MRs (revised August 2025) (October 2025)
- Slide of lecture "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)
- JPMA Web site release] PV: KT5 Pharmacovigilance Regulatory Survey Report Form (August 2025)
- Slide presentation "Provision of Adverse Reaction Information: The Way of Information Provision 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 RMP/RMP Materials Utilization - Mainly for Dispensing Pharmacies (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 Drug Information) (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)
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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 Stage 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)
- Explanation of Procedural Guidance for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / "Q&A on Investigation of Usage Results of Ethical Drugs Using the All Patient Surveillance Method (October 2024)
- Results of Questionnaire on the Status of DCT Introduction and on 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)
- 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 Toward Society 5.0 (Data Society) and Proposals for Utilization of Digital Technology (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 of open source software applications (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) Explanation (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 Care 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 (JPMA 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 JPMA 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)
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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) (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)
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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 Assessment 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, etc. (From Internal Proposal to Registry Modification) (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)- (Explanation, 2022 Edition) (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)
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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)
- Directions for MSLs (July 2022)
- Considerations for Using Real World Data as External Controls for Regulatory Applications (July 2022)
- Issues to be considered for ensuring the reliability of post-marketing database surveys (July 2022) (June 2022)
- Let's learn about "Pharmaceuticals" and "Clinical Trials"! (Audio description) (April 2022) (April 2022)
- Guidance for Preparation of "Electronic Drug Information Sheet for Prescription 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)
- JPMA Recommended Form for Communicating Safety Information to Medical Institutions Conducting Clinical Trials (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)
- Explanation 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 Explanation) (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 Revisions to the 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)
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Commonly used analysis shells and ADaM data for clinical study reports (December 2019)
- Overview and Considerations for Network Meta-Analysis (November 2019)
- Additional Risk Minimization Activities 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)
- 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)
- 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 Reasonable 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 Explanations for "Precautions for Use" of New Drugs (March 2019)
- Evaluation Indicators for Survival Time-Type Responses (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)
- 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 (JPMA model) (February 2012) (February 2012)
- Explanation of the CDASH standard that defines data items for case report forms (December 2011) (December 2011)
- Division of Roles 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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