Top News ICH Athens Meeting Held in Hybrid Format for the First Time

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plenary meeting for the first half of 2022 was held in Athens, Greece, from May 21-25, 2022. For the first time in ICH history, the meeting was held in a hybrid format, combining face-to-face meetings and web conferencing.

At this meeting, the Management Committee, which is in charge of preparing proposals for the Assembly and managing the ICH, and the Assembly, in which all members participate, were held. Discussions in the Expert Working Groups (Working Groups) were also held in parallel at the same time to make progress in the preparation of ICH guidelines. The importance of the face-to-face meetings became clear.

The Athens meeting was attended by 6 industry-government organizations, 2 standing members (Health Canada and Swissmedic), 12 members, 2 standing observers, and 21 observers from Japan, the U.S., and the EU, all of which are founding members. Twelve members from JPMA traveled to Athens for the local conference. Since participants came from all over the world, including Japan, the U.S., Europe, and Asia, a core time slot was set aside each day during which participants from around the world could participate via the Web, and important issues were discussed and focused on during this time. This core time slot was basically set from 2:00 p.m. to 4:00 p.m. Greek time. This would be from 20:00 to 22:00 in Japan and from 7:00 to 9:00 on the East Coast of the United States. This setting worked because this plenary session was held in Europe, but would be impractical for holding plenary sessions in other regions. In order to manage the meeting more efficiently, the Incheon meeting in the fall of 2022 (Korea) will basically be held in a face-to-face format instead of a hybrid format.

The following are special notes from the Athens meeting.

1. approval of ICH members and observers

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) was approved as a new member of the ICH, having previously been a founding regulatory member of the European Commision (EC), but lost that status when the UK left the European Union and has since been an independent observer organization. Since then, it has participated as an independent observer organization, but has now been elevated to member status through an expedited process. The Algerian National Agency for Pharmaceutical Products (ANPP) was also approved as a new observer.

As a result, the number of ICH members increased by 1 from 19 to 20, and the number of observers increased by 1 to 35, bringing the total number of ICH members to 55 (see the reference material at the end of this report).

Trends in ICH Topics

At the Athens meeting, technical topics were discussed in a hybrid format (face-to-face/web conferencing). Although the number of working groups was smaller than usual, working groups on all seven topics listed below took advantage of this period to meet and make progress. In addition, the Management Committee and Assembly also managed the progress of all existing topics, made decisions on Step transition, and discussed new topics.

Experts and Implementation Working Groups

The seven topics that met during this Athens meeting were as follows

Reach Step 4

The following topics were reported as having reached Step 4. These are now in the process of implementation by the respective regulatory authorities.

Step2 Reach

M12: "Drug Interactions Studies" was reported as having reached Step 2. Public comments will be made in each country/region.

Approval of new topics

Inclusion of Pregnant and Lactating Women in Clinical Trials" was adopted for the launch of a new working group to develop guidelines in the future.

3. Next ICH Meeting

The meeting will be held in Incheon, Korea, November 12-16, 2022. Based on the experience of the Athens meeting, the meeting will be held in a face-to-face meeting in principle.

The ICH is committed to actively disclosing information on its activities, including the outcomes of the ICH meetings, in order to deepen understanding of the ICH activities not only among the concerned parties but also among the general public. The results of the ICH Athens meeting, concept papers and work plans for each topic are available on the ICH website ( https://www.ich.org/ ).

Reference: List of ICH Members and Observers (as of June 2022)

Table 1 Members (20 organizations)

Table 2 Observers (35 organizations)

( Mariko Kato, Director, International Regulatory Coordination Department)

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