Topics ICH Vancouver Conference to be Held in Web Conference Format

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the first meeting of 2020, was scheduled to take place in Vancouver, Canada Vancouver, Canada, May 23-27. However, in light of the global pandemic of novel coronavirus infection, the face-to-face meeting was abandoned in favor of a web conference for the first time in ICH history in order to prevent the spread of infection. Since participants came from Japan, the U.S., Europe, and Asia, the meeting time was set in the evening in Japan (morning in the U.S., Canada, and Brazil; afternoon in Europe and Africa; and evening or night in Asia), and the Management Committee meetings were held on May 13, 25, and 26, and the Assembly on May 27, with a two-hour program each day. Expert/Implementation Working Group (Working Group) discussions were also held at the same time and in parallel with each other to make progress on ICH topics.

Below are some special notes from the Vancouver meeting (web conference).

1. Approval of ICH members and observers

The Turkish Medicines and Medical Devices Agency (TITCK) was approved as a new member of ICH, having previously been an observer organization. The Ministry of Public Health (MOPH) of Lebanon was also approved as a new observer organization.

As a result, the number of ICH members increased by one from 16 to 17, and the number of observers decreased by one to 32, bringing the total number of ICH members to 49 (see the reference material at the end of this report).

Extension of the terms of the Chair and Vice-Chair of the Management Committee

The Management Committee's Rules of Procedure (RoP) have been revised, extending the terms of office of the Chair and Vice-Chair from one year to two years. This brings them in line with the terms of the Chair and Vice-Chair of the Assembly. The current Vice Chair of the Management Committee is Nobumasa Nakajima, Executive Officer of the Pharmaceuticals and Medical Devices Agency (PMDA).

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. In addition, the Management Committee and Assembly also discussed the Step transition of existing topics and new topics.

Step4 reached

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

Step2 Attainment

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

Approval of new topics

The following two topics were approved for the launch of a new WG to develop guidelines

Since the above two topics are interrelated, it was decided to proceed with the revision of M4Q (R1) first. However, since it is necessary to refer to the content of another topic currently under discussion in order to proceed with this study, the WG is expected to be established around December of this year. Regarding the other topic, "Structuring Quality-related Application Materials," the WG will be established and start its activities after the revision of M4Q (R1) has been discussed to some extent.

Establishment of Discussion Group (DG)

It was decided to establish a Discussion Group (DG) for the following new topic proposals, which will not directly proceed to guideline development, but will instead be studied for the purpose of making them into topics. Since these two topics are closely related, they will be discussed including how to make them into topics.

Toward the 30th Anniversary of ICH

In conjunction with the ICH Athens meeting (November 2020), the ICH 30th anniversary will be celebrated on November 14, 2020. The event will include lectures and panel discussions on key guidelines in each of the areas of Q (Quality), S (Safety), E (Efficacy), and M (Multidisciplinary), followed by a comprehensive panel discussion to review the past 30 years of ICH and discuss the next 10 years. In addition, a panel discussion to commemorate the 30th anniversary of ICH and lectures in each area will be held in conjunction with the Drug Information Association (DIA) annual meetings in major regions (Japan, the U.S., and Europe).

Schedule of Future ICH Assembly Meetings

The face-to-face meeting was scheduled to be held in Athens, Greece from November 14 to 18, 2020, but due to the pandemic of the new coronavirus infection, the meeting will be held via web conference, as was the Vancouver meeting this time.

The ICH is committed to actively disclosing information on ICH activities, including the outcomes of ICH meetings, in order to deepen the understanding of not only those involved but also the general public. Please refer to the ICH website for the outcomes of the ICH Vancouver meeting (web meeting), concept papers on each topic, work plans, etc.

Reference: List of ICH Members and Observers (as of June 2020)

Table 1 Members (17 organizations)

Table 2 Observers (32 organizations)

( Manabu Yanagisawa, Director, International Regulatory Coordination Department)

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