• Last updated：2025-01-03
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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international platform initiated in 1990 by regulatory authorities and pharmaceutical industry associations from the United States, European Union, and Japan. Its primary function is to harmonize and standardize pre-market registration and post-marketing regulatory requirements for pharmaceuticals among member countries. This is achieved by forming Expert Working Groups (EWGs) to discuss and consolidate divergent regulations on specific topics, which are then endorsed by the Steering Committee as internationally recognized standards, thereby promoting global harmonization and regulatory alignment.

Taiwan became an observer of ICH in 2016 and officially joined as a Regulatory Member on June 7, 2018, after ICH was registered as an international association in October 2015.

The Center for Drug Evaluation (CDE) assisted the former Department of Health (restructured as the Ministry of Health and Welfare in 2013) in proposing the "bridging study evaluation" for accepting overseas clinical trial data. Since 2003, CDE has accompanied the Director-General of the Health Bureau to represent Taiwan in ICH-GCG (Global Cooperation Group) meetings as part of APEC delegations. Starting from 2011, ICH opened membership for countries recommended by GCG members to nominate experts to participate in EWGs. Consequently, CDE assigned experts to participate in the Q3D working group meetings. Since then, CDE has actively recommended senior reviewers to participate in new ICH organizational discussions, contributing to 29 working groups with a total of 39 colleagues involved, serving as lead representatives in 16 of these groups.

The current organizational structure of ICH includes the Assembly, Management Committee, and Expert Working Groups responsible for drafting guidelines (refer to the diagram below)

https://www.ich.org/page/organisation-ich

Guideline

Regarding ICH guidelines, please visit ICH official website : https://www.ich.org/page/ich-guidelines. Regarding the domestic adoption list, please refer to the website of the Taiwan Food and Drug Administration. The website address is: https://www.fda.gov.tw/TC/site.aspx?sid=10221&r=1192485399.

2023

In 2023, colleagues from the Center for Drug Evaluation (CDE) participated in a total of 403 physical and online discussions with ICH working groups. Biannual face-to-face meetings were conducted throughout the year: in March, temporary face-to-face meetings for M4Q(R2) and M12 working groups were held in Geneva, Switzerland. In June, meetings were convened in Vancouver, Canada, involving E2D(R1), Q3E, Q9(R1), E11A, Q5A(R2), E21, E20, M15, and M4Q(R2) working groups. In the second half of the year, physical meetings took place in Prague, Czech Republic, with Q3E, Q9(R1), M4Q(R2), M15, E11A, M13, E20, E21, M12, and Q5A(R2) working groups in attendance. Experts from the Center participated in these meetings, contributing Taiwan's perspectives and reaching consensus on guideline discussions.

2022

In 2022, colleagues from the Center for Drug Evaluation (CDE) participated in a total of 373 physical and online discussions with ICH working groups. Biannual face-to-face meetings were scheduled: due to the pandemic, the first half of the year involved online participation, while the second half held physical meetings in Incheon, South Korea. The meetings included Q3E, Q9(R1), M4Q(R2), M15, E11A, E2D(R1), and M13 working groups. Representing the Center in person were Deputy Director Lu Ching-You, Reviewer Lin Yi-Shan, Section Chief Lin Yi-Ying, Reviewer Tu Chien-Lung, and Senior Clinical Reviewer Wang Ya-Lei. Reviewer Wang Jun-Fon, Reviewer Chang Yi-Ting, and Senior Pharmacokinetic Reviewer Wang Yi-Lin participated online in the guideline discussions.

2021

In 2021, colleagues from the Center for Drug Evaluation (CDE) participated in a total of 332 online discussions with ICH working groups. Biannual face-to-face meetings, affected by the pandemic, were conducted via video conferencing. The meetings included E2D(R1), E11A, M12, M13, and Q3E working groups. Representing the Center were Reviewers Wang Jun-Fon, Wang Ya-Lei, Wang Yi-Lin, Section Chief Yang Shih-Ying, Reviewer Chang Yi-Ting, Deputy Director Lu Ching-You, and Section Chief Jhuang Bing-Cheng, who participated in the guideline discussions.