Topics. ICH Vancouver Meeting to be Held via Web Conference

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was scheduled to meet in Vancouver, Canada, in the second half of 2021. This is the fourth consecutive online meeting since the Vancouver meeting in the first half of 2020.

The Management Committee will meet on November 9, 15, and 16, 2021, and the Assembly on November 17 and 18, 2021, for two hours each day. The Expert/Implementation Working Groups (Working Groups) discussions were also held in parallel at the same time and in web conference format, respectively, to make progress on ICH topics. The following is a list of special notes from the Vancouver meeting (web conference).

1. Approval of ICH members and observers

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) approved the Federal Commission for Protection against Sanitary Risks (COFEPRIS) Mexico as a new member, having previously been an observer. Badan Pengawas Obat dan Makanan (BPOM) Indonesia, the State Expert Center of the Ministry of Health of Ukraine (SEC MOH) and the Egyptian Drug Authority (EDA) were also approved as new observers.

As a result, the number of ICH members increased by 1 from the previous 18 to 19, and the number of observers increased by 3 to 35, bringing the total number of ICH members to 54 (see the reference material at the end of this document).

2. Election of Chairpersons of ICH Assembly and Management Committee

The Chair and Vice-Chair of the Assembly and the Chair and Vice-Chair of the Management Committee are elected every two years, and the Chair and Vice-Chair of the Management Committee are elected every one year (although this year the election was changed to every two years). As a result, Ms. Gabriela Zenhaeusern (Swiss authorities) was elected as the new Vice Chair of the Assembly, and the remaining Chair and Vice Chair of the Management Committee were re-elected. Mr. Nobumasa Nakajima, Executive Officer of the Pharmaceuticals and Medical Devices Agency (PMDA), is the Vice-Chair of the Management Committee.

3. Trends in ICH topics

Working groups (WGs) on topics that were scheduled to meet face-to-face at the Vancouver meeting took advantage of this period to make progress by vigorously conducting web conferences. Other meetings of the Management Committee and Assembly also discussed the Step transition of existing topics and the discussion of new topics.

Reaching Step 4

The following topics were reported as having reached Step 4. These will enter the process of implementation in the respective regulators.

•	E8(R1): General Considerations for Clinical Studies
•	M8: eCTD v4.0 (Q&A v1.6, etc.)

Reach Step 2

The following topics were reported as having reached Step 2. Public comments will be made in each country/region.

•	Q13: Continuous Manufacturing of Drug Substances and Drug Products
•	Q9(R1): Quality Risk Management
•	M7 (R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Movement toward initiating activities on adopted topics

The following two informal working groups (informal WGs) will be established and start activities in the future The following two informal working groups (informal WGs) will be established and will start their activities in the future.

•	An informal WG has been established as M14 for " General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines", one of the new topic candidates adopted at the Incheon meeting (web conference) in the first half of 2021, and will start its activities soon. 4.
•	The Assembly approved the concept paper on "General Principles for Model-Informed Drug Development" which was discussed in the discussion group on Model-informed Drug Development (MIDD). The informal WG is scheduled to start in June 2022. 4.

4. commemorating the 30th anniversary of ICH

The ICH 30th Anniversary Book, which outlines the history and current status of ICH, is now available on the ICH website, and includes views from various stakeholders on the future direction of ICH activities, including how ICH can contribute to health promotion in the future.

5. next ICH meeting

The next ICH meeting will be held in Athens, Greece, from May 21 to 25, 2022. Considering the impact of the pandemic of the new coronavirus, it is under consideration whether the meeting will be held in person or via web conference, as was the case at the Vancouver meeting.

The ICH is actively disclosing information on its activities, including the outcomes of the ICH meetings, in order to deepen the understanding of not only those involved but also the general public. The results of the ICH Vancouver meeting (web conference), concept papers on each topic, work plans, etc. are available on the ICH website ( https://www.ich.org/home.html ).