Drug Evaluation Committee Communications from the Drug Evaluation Committee List of all communications
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- Asian eCTD / Gateway System Information Publication (December 2025)
- Common Template for Explanatory and Consent Documents (ICF) (November 2025)
- Clinical Trials Ecosystem Industry Declaration on Quality Issues 2025 (October 2025)
- The Drug Evaluation Committee Chairman, Dr. Nakaji, was interviewed by Nikkan Yakugyo in a series of articles entitled "Toward the Era of Co-Creation <3>". (Sep. 2025)
- How to Find Clinical Trials - jRCT Mikakata - 3rd Edition (July 2024) (July 2024)
- Overview and Key Points of the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects (July 2024)
- Explanation of the RMP Mark (Revised 2024) (June 2024)
- Guidelines for Joint Clinical Research Using Ethical Drugs and Other Products (enacted May 10, 2024) (May 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)
- List of items to be enrolled in studies transitioning from JapicCTI Initial version
Comparative Table of jRCT-JapicCTI Registration Items, 2nd ed. (October 2023) - Briefing on Revised Pharmaceuticals and Medical Devices Act related Notification and Online Submission of Clinical Trial Notification" held on February 6, 2023 (February 2023) (February 2023)
- Briefing on Registration of Clinical Trials held on April 20, 2022 (April 2022) (April 2022)
- The Pharmaceutical Manufacturers Association of Japan (PMAJ) recommends "Forms for communicating safety information to medical institutions conducting clinical trials" (April 2022) (April 2022)
- Presentation materials for "Workshop on Pediatric Drug Development" held on March 29, 2022 are now available. (April 2022)
- The utilization of digital biomarkers (dBM) in drug development and the requirements for their use. (Apr. 2022)
- Characteristics of electronic certificates used in the application electronic data system. (Mar 2022)
- Declaration of Data Integrity - Our Declaration" to ensure the reliability of clinical trials and clinical studies (Mar. 2022)
- Q&As on "Registration of Clinical Trials" (Pharmaceutical Affairs Bureau of Japan, No. 0831/9, August 31, 2020) (3rd Edition) (March 2022)
- Briefing on the Revised Pharmaceuticals and Medical Devices Act held on February 22, 2022 -Responses, etc. required of pharmaceutical companies based on notifications and examples- (February 2022) (February 2022)
- Briefing on the Revised Pharmaceuticals and Medical Devices Act -Impact of the Introduction of Investigational New Drugs on Clinical Trials-," held on February 22, 2022 (February 2022) (February 2022)
- Information Meeting on the Revised Pharmaceuticals and Medical Devices Act (related to Notification of Clinical Trials and Reporting of Adverse Reactions to Clinical Trials) (June 2021) (June 2021)
- Points to keep in mind regarding support for investigator-initiated clinical research under the influence (coronary disaster) of novel coronavirus infection (COVID-19) (October 2020) (October 2020)
- jRCT/Japic CTI Registration Item Comparison Chart. (September 2020)
- Briefing materials on registration of clinical trial implementation status, etc. (Aug. 18 Web-based meeting) (August 2020)
- Statement from the Data Science Subcommittee of the Drug Evaluation Committee regarding COVID-19 (May 2020)
- Implementation and management of clinical trials and clinical studies under the spread of novel coronavirus infection (COVID-19) (April 2020) (April 2020)
- Q&A from the Pharmaceutical Manufacturers Association regarding the "Clinical Research Act and Enforcement Regulations of the Clinical Research Act" (November 2019) (November 2019)