ICH Project 42nd ICH Public Meeting (Held Online)

December 1, 2020

To widely share information on ICH developments with representatives from companies involved in pharmaceutical development and safety assurance, as well as the general public, we held the 42nd ICH Public Meeting online on December 16, 2020.

In previous years, this meeting served as a forum to present “immediate reports” on the progress of topics that had been the subject of intensive in-person discussions at the ICH plenary meetings.However, due to the spread of COVID-19, both ICH plenary meetings this year were held virtually. As a result, intensive in-person discussions on these topics could not take place; therefore, unlike in previous years, the report focused on only a few topics where recent progress had been made.

The program, presentation schedule, and presentation materials for this briefing are attached below and can be viewed directly at the following link:
Please note that unauthorized copying or reproduction of the attached materials is prohibited.

Date, Time, and Location

Date and Time Format
Wednesday, December 16, 2020, 1:00 PM – 4:40 PM Online (WebEx)

Information and Program

Event Announcement / Program

Presentation Materials

Presentations Speakers

01_ICH Trends (1,430 KB)

Etsuyo Tanabe (Ministry of Health, Labour and Welfare)

02_ICH Trends—From the JPMA Perspective—(2,230 KB)

Masafumi Yokota (JPMA)

03_S1 (R1): Rodent Carcinogenicity Studies for Human Pharmaceuticals
: Carcinogenicity Testing for Pharmaceuticals (Revised) (634 KB)

Kumiko Ogawa (National Institute of Public Health)

04_S12: Nonclinical Biodistribution Considerations for Gene Therapy Products
Nonclinical Biodistribution Considerations for Gene Therapy Products (296KB)

Yuto Takishima (NIH)

05_Q3C (R8): Residual Solvent in Pharmaceuticals
_Q3D (R2): Revision of the “Guideline for Elemental Impurities in Pharmaceuticals” (472KB)

Akihiko Hirose (National Institute of Public Health)

06_Q9 (R1): Quality Risk Management (166KB)

Tomoaki Sakamoto (National Institute of Health Sciences)

07_Q3E: Guideline for Extractables and Leachables (E&L)
Evaluation and Management of Extractables and Leachables in Pharmaceuticals and Biopharmaceuticals (373KB)

Hiroshi Takeda (NIH)

08_Q5A (R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (575KB)

Yoji Sato (National Institute of Public Health)

09_Q2 (R2)/Q14: Analytical Procedure Development and Revision of Q2 (R1)
: Revision of the “Guidelines for Analytical Procedure Validation” (406KB)

Akiko Mase (NIH)

10_Q13: Continuous Manufacturing of Drug Substances and Drug Products
: Continuous Manufacturing (316KB)

Yasuhiro Matsui (JPMA)

11_M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Bioequivalence Evaluation of Immediate-Release Solid Oral Dosage Forms (209KB)

Ryosuke Kuribayashi (NIH)

12_E8 (R1): General Considerations for Clinical Studies
Revision of General Considerations for Clinical Studies (1,013KB)

Hiroshi Sakaguchi (NIH)

13_E11A: Pediatric Extrapolation (249 KB)

Shinichi Kijima (NIH)

14_E20: Adaptive Clinical Trials (157 KB)

Yuki Ando (NIH)

15_M11: CeSHarP (1,153 KB)

Ken Sakushima (NIH)

16_M12: Drug Interaction Studies (964KB)

Kokoro Hoshino (NIH)

 

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