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The ICH Assembly met in Kobe, Japan on 6 & 7 June 2018.

For more information on the meeting, see the ICH Press Release.

The MedDRA Management Committee met in Kobe, Japan on 2 & 3 June 2018.

For more information on the meeting, see the MedDRA Press Release.

The ICH MC Chair and Vice Chair welcomed five new ICH Members to the ICH MC in Kobe, Japan, June 2018. Three regulatory members: CFDA, China; HSA, Singapore and MFDS, South Korea. And two industry members: BIO and IGBA.

The ICH Assembly Chair and Vice Chair welcomed TFDA, Chinese Taipei as ICH’s newest Regulatory Member at the Kobe meeting.

(L – R: Ms. Chao-Yi Wang; Ms. Yi-Jing Kuo; Ms. Lenita Lindström-Gommers; Ms. Hsiao-Han Chiang; Dr. Toshiyoshi Tominaga and Dr. Churn-Shiouh Gau)

The ICH Assembly Chair and Vice Chair welcomed NPRA, Malaysia as a new ICH Observer at the Kobe meeting.

(L – R: Dr. Ramli Zainal; Ms. Lenita Lindström-Gommers; and Dr. Toshiyoshi Tominaga)

The ICH Assembly Chair and Vice Chair welcomed TITCK, Turkey as a new ICH Observer at the Kobe meeting.

(L – R: Ms. Nihan Burul Bozkurt; Ms. Lenita Lindström-Gommers; and Dr. Toshiyoshi Tominaga)

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities... (more)

ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy ... (more)

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines... (more)

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.  It includes the ICH medical terminology (MedDRA)... (more)

The agreement to assemble all the Q, S, and E information in a common format (called CTD - Common Technical Document) has revolutionized the regulatory review processes... (more)

MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. ... (more)