Topics ICH Vancouver Conference" held in web conference format

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The first ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) plenary meeting in 2020 will be held in Vancouver, Canada The meeting was scheduled to take place from May 23 to 27 in Vancouver, Canada. 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). Expert/Implementation Working Group (Working Group) discussions were also held at the same time, each in parallel, 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 Institute for Therapeutic Products and Medical Devices (TITCK) was approved as a new member of ICH, having been an observer organization until now. 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 increased by one to 32, bringing the total number of ICH organizations to 49 (see the reference material at the end of this report).

2. extension of the term of office of the Chair and Vice-Chair of the Management Committee

The Rules of Procedure (RoP) of the Management Committee were revised and the term of office of the Chair and Vice-Chair was extended from one year to two years. This brings them in line with the terms of the Chair and Vice-Chair of the General Assembly. The current 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. In addition, the Trustees and the General Assembly also discussed the Step transition of existing topics and new topics.

Reached Step4

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

M8 (Development of electronic specifications for eCTD v4.0) Q&A v1.3: Q&A for eCTD
S11: Guidelines for non-clinical studies in pediatric drug development
S5 (R3): Guidelines for Reproductive and Developmental Toxicity Testing Methods for Pharmaceuticals (Revised)

Reached Step 2

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

Q3C (R8): Revision of "Guidelines for residual solvents in pharmaceutical products

Approval of new topics

The following two topics were approved for the launch of a new working group to develop guidelines.

Revision of "CTD - Guideline for the Preparation of Quality-related Documents" (Revision of M4Q (R1) Guideline)
Structuring of Quality-related Submission Documents"

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. As for the other topic, "Structuring Quality-related Application Materials," the WG will be established and start its activities after some progress is made on the revision of M4Q (R1).

Establishment of Discussion Group (DG)

As for the following new topic proposals, it was decided not to proceed directly to guideline development, but to establish a study group (DG) to study how to make them into topics. Since they are closely related to each other, the DG will discuss how to make them into topics.

General Guidelines for Drug Development Based on Model Information to Support Drug Registration (MIDD)
Dose-Response Information to Support Drug Registration (Revised E4 Guideline)

Toward the 30th Anniversary of ICH

In conjunction with the ICH Athens meeting (November 2020), a celebration of ICH's 30th anniversary will be held on November 14. The event will include presentations and panel discussions on key guidelines in the areas of Q (quality), S (safety), E (efficacy), and M (multidisciplinary), respectively, 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, US, and Europe) (as mentioned below, the timing of this event is under consideration since the Athens meeting was held via web).

Upcoming ICH General 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 in the form of a 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. The outcomes of this ICH Vancouver meeting (web conference), concept papers on each topic, work plans, etc. are available on the ICH website Please refer to the ICH website for the results of the ICH Vancouver meeting, concept papers on each topic, work plans, etc.