Topics "ICH Vancouver Conference" to Be Held via Web Conference

Printable PDF

The first ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) plenary meeting of 2020 was originally scheduled to take place in Vancouver, Canada, from May 23 to 27.However, in light of the global COVID-19 pandemic and to prevent the spread of the virus, the decision was made to cancel the in-person meeting; instead, the event will be held via web conference—a first in ICH history.Since participants were joining from Japan, the U.S., Europe, and Asia, the meeting times were set for the evening in Japan (morning in the U.S., Canada, and Brazil; daytime in Europe and Africa; and evening to night in Asia). The Management Committee met on May 13, 25, and 26, and the Assembly met on May 27, with a two-hour program each day.In addition, discussions by expert and working groups were held in parallel during the same period to advance progress on ICH topics.

Notable items from the Vancouver meeting (web conference) are listed below.

1. Approval of ICH members and observers

The Turkish Medicines and Medical Devices Agency (TITCK) was approved as a new ICH member. TITCK had previously been an observer organization but was granted full membership status at this meeting. Additionally, the Ministry of Public Health of Lebanon (MOPH) was approved as a new observer organization.

As a result, the number of ICH members increased by one from 16 to 17, while the number of observers increased by one and decreased by one, bringing the total to 32. ICH now comprises a total of 49 organizations (see reference materials at the end).

2. Extension of the Terms of Office for the Chair and Vice-Chair of the Management Committee

The Rules of Procedure (RoP) of the Management Committee were revised, extending the terms of office for the Chair and Vice-Chair from one year to two years. This brings their terms into alignment with those of the Chair and Vice-Chair of the Assembly.Currently, the Vice Chair of the Management Committee is Mr. Nobumasa Nakajima, an Executive Officer at the Pharmaceuticals and Medical Devices Agency (PMDA).

3. Trends in ICH topics

The working groups (WGs) for topics that were scheduled to be discussed in person at the Vancouver meeting took advantage of this period to actively hold web conferences and make progress. In addition, the Management Committee and the Assembly discussed the transition of existing topics to the next step and deliberated on new topics.

Reaching Step 4

It was reported that the following topics have reached Step 4. These topics will now enter the implementation process at each regulatory authority.

M8 (Development of Electronic Specifications for eCTD v4.0) Q&A v1.3: eCTD Q&A
S11: Guidelines on Nonclinical Studies for the Development of Pediatric Medicines
S5 (R3): Guidelines on Reproductive and Developmental Toxicity Testing Methods for Medicinal Products (Revised)

Reached Step 2

Reach of Step 2 has been reported for the following topics. Public comment periods will be held in each country and region going forward.

Q3C (R8): Revision of the “Guideline on Residual Solvents in Medicinal Products”

Approval of New Topics

The following two items were approved in preparation for the launch of new working groups to develop guidelines:

Revision of the “Guideline on the Preparation of Quality Documentation for CTD” (Revision of the M4Q (R1) Guideline)
“Structuring of Quality Submission Documents”

Since the two topics above are interrelated, it was decided to proceed first with the review of the M4Q (R1) revision. However, as this review requires reference to the findings of another topic currently under discussion, the working group is expected to be established around December of this year.As for the other topic, “Structuring of Quality-Related Submission Documents,” it was decided that a working group (WG) will be established and begin its activities once the review of the M4Q (R1) revision has progressed to a certain extent.

Establishment of a Discussion Group (DG)

Regarding the following proposals for new topics, rather than proceeding directly to the creation of guidelines, it has been decided to establish Discussion Groups (DGs) to conduct deliberations aimed at defining these topics. Since these two topics are closely related, deliberations will include how to structure them as separate topics.

“General Guidelines on Drug Development Based on Model Information to Support Drug Registration” (MIDD)
“Adverse Reaction Information to Support Drug Registration” (Revision of the E4 Guideline)

4. Toward the 30th Anniversary of ICH

In conjunction with the ICH Athens Meeting (November 2020), an event commemorating ICH’s 30th anniversary will be held on November 14.The program will feature presentations and panel discussions focused on key guidelines in each of the Q (Quality), S (Safety), E (Efficacy), and M (Multidisciplinary) domains, followed by a comprehensive panel discussion reflecting on the past 30 years of ICH and discussing the next 10 years.In addition, ICH 30th-anniversary panel discussions and presentations in each domain will be held in conjunction with the annual meetings of the Drug Information Association (DIA) in major regions (Japan, the U.S., and Europe). (As noted below, since the Athens meeting was held online, the timing for these events is currently under consideration.)

5. Schedule for Future ICH Assembly Meetings

An in-person meeting was originally scheduled to take place in Athens, Greece, from November 14 to 18, 2020; however, due to the COVID-19 pandemic, it will be held online, similar to the Vancouver meeting.

Furthermore, ICH actively publishes information regarding its activities, including the outcomes of ICH meetings, to foster a deeper understanding not only among stakeholders but also among the general public. The outcomes of this ICH Vancouver Meeting (virtual conference), as well as concept papers and work plans for each topic, are available on the available on the ICH website .