ICH Project 43rd ICH Instant Reporting Session (Web-based)

July 07, 2021

The 43rd ICH Informal Debriefing Session was held on July 7, 2021 on the web to present and discuss the outcome of ICH Incheon (May 25, 2021 and June 1-3, 2021, WEB) to share information on the progress of ICH with companies in charge of drug development and safety assurance as well as the general public. The 43rd ICH Debriefing was held on July 7, 2021 on the web.

In this meeting, the experts from the working groups reported on the latest developments of ICH, including the results of the Incheon Meeting and new topics, and discussed the trends in the topics of efficacy, electronic standards for the communication of regulatory information, safety, and quality. The program of the meeting and the time allotted for the presentations were as follows.

The program and timetable of the meeting are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached contents is strictly prohibited.

Date, time and place

Date and Time Method of the event
Wednesday, July 7, 2021, 13:00-17:00 Online (Zoom)

Information and Program

Information / Program (351KB)

Presentation Speaker
01_ICH Trends - Report on the June 2021 ICH General Assembly and Management Committee Meeting (Virtual, Incheon) (1,856KB) Egyo Tanabe (MHLW)
02_ICH Trends - Perspectives from the Pharmaceutical Association of Japan (2,033KB) Masafumi YOKOTA (Pharmaceutical Manufacturers' Association of Japan)
03_E8(R1): General Considerations for Clinical Studies
Revision of "General Guidelines for Clinical Studies" (369KB)		 Mutsuhiro Ikuma (NIMS)
04_E6(R3): GCP (Good Clinical Practice) (578KB) Kanako Ito (NIH)
05_M8: eCTD IWG/EWG (358KB) Ryo Saito (NIMS)
06_M7 (R2): Revision of "Assessment and Control of DNA Reactivity (Mutagenicity) in Drugs to Reduce the Potential Carcinogenic Risk
Revision of "Evaluation and Control of Impurities" (1,131KB)		 Masamitsu Homma (National Institute of Health Sciences)
07_S1B(R1): Revision of Carcinogenicity Testing of Pharmaceuticals (1,057KB) Kumiko OGAWA (NIHS)
08_S12: Nonclinical Biodistribution Considerations for Gene Therapy Products
Nonclinical Biodistribution Considerations for Gene Therapy Products (447KB)		 Yuto Takishima (NIH)
09_Q2(R2)/4: -Analytical Procedure Development and Validation Revision
-Analytical Procedure Development and Analytical Validation- (903KB)		 Hiroko SHIBATA (NIH)
10_Q3C(R8): Residual Solvents in Pharmaceuticals (304KB) Hironori Matsumoto (General Organization)
11_Q13：Continuous Manufacturing of Drug Substances and Drug Products
（11_Q13：Continuous Manufacturing of Drug Substances and Drug Products (324KB)		 Hironori Matsumoto (General Organization)

The End

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