Topics ICH Vancouver Meeting" held via web conference

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The International Conference on Harmonization of Pharmaceutical Regulations (ICH) plenary meeting in the second half of 2021 was scheduled to take place in Vancouver, Canada. This is the fourth consecutive online meeting since the Vancouver meeting in the first half of 2020.

Since participants will come from Japan, the U.S., Europe, and Asia, the meeting will be held in the evening (morning in the U.S., Canada, and Brazil; afternoon in Europe and Africa; and evening or night in Asia), with the Management Committee meeting on November 9, 15, and 16, 2021, and the General Assembly on November 17 and 18, 2021, each day for two hours. 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

COFEPRIS was approved as a new member of the International Conference on Harmonization of Pharmaceutical Regulations (ICH), having previously been an observer. The Food and Drug Administration of the Republic of Indonesia (BPOM), the Expert Center of the Ministry of Health of Ukraine (SEC MOH), and the Egyptian Drug Agency (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).

Election of Chairpersons of ICH General Assembly and Management Committee

The Chair and Vice-Chair of the ICH General Assembly 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 General Assembly, and the remaining Chair of the General Assembly and Chair and Vice Chair of the Management Committee were re-elected. The Vice-Chair of the Management Committee is Nobumasa Nakajima, Executive Officer of the Pharmaceuticals and Medical Devices Agency (PMDA).

3. developments on 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 Trustees and the General Assembly were held to discuss the Step migration of existing topics and new topics.

Reached Step4

The following topics were reported to have reached Step 4. These are now in the process of implementation by the respective regulators.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E8(R1): General Guidelines for Clinical Trials (Revised)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M8: eCTD v4.0 (Q&A v1.6, etc.)

Reached Step 2

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

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q13: Serial production
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q9 (R1): Quality Risk Management (revised)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M7 (R2): Evaluation and management of mutagenic impurities (revised)

Movement toward initiation of activities for adopted topics

The following two informal working groups (informal WGs) have been established and will begin their activities A concept paper and business plan will be developed.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Among the new topic candidates adopted at the Incheon meeting (web meeting) in the first half of 2021, an informal WG has been established as M14 on "General principles for the planning and design of pharmacoepidemiological studies utilizing RWD for safety assessment of drugs" and will be activated soon.
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	The General Guideline for MIDD", which was discussed in the discussion group on Model-informed Drug Development (MIDD), was approved at the Plenary Meeting. The concept paper is scheduled to be launched in June 2022.

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 various stakeholders have expressed their views on the future direction of ICH activities, including how ICH can contribute to health promotion in the future.

Next ICH Meeting

The conference is scheduled to be held in Athens, Greece, from May 21 to 25, 2022. Considering the impact of the new coronavirus pandemic, 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 outcomes 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 ).