Top News ICH Athens Meeting" held in a hybrid format for the first time

Printable PDF

The International Conference on Harmonization of Pharmaceutical Regulations (ICH) plenary meeting for the first half of 2022 was held in Athens (Greece) from May 21 to 25, 2022. For the first time in the history of ICH, the meeting was operated in a hybrid format combining face-to-face meetings and web conferencing.

Group photo

The meeting included the preparation of proposals for the General Assembly, the Management Committee, which is responsible for the operation of the ICH, and the General Assembly, in which all members participate. Discussions in the Expert Working Groups (Working Groups) were also held in parallel at the same time to make progress in the preparation of the ICH Guidelines. The importance of the face-to-face meetings became clear.

The Athens meeting was attended by 6 industry-government organizations, 2 permanent members (Health Canada and Swissmedic), 12 members, 2 permanent observers, and 21 observers from Japan, the U.S., and the EU. Twelve members from the Pharmaceutical Manufacturers Association of Japan (PMAJ) traveled to Athens. 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.

Below are some 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 ICH, having previously been a member of the European Council (EC) with the status of a founding regulatory body, which it lost when the UK left the European Union (EU), and has since joined as an independent observer body. 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).

2) ICH Topic Trends

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 Trustees and the General Assembly managed the progress of all existing topics, made decisions on Step transition, and discussed new topics.

Expert and Implementation Working Groups

The following seven topics were discussed at the Athens meeting

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

E6 (R3): Revision of "Standards for the Conduct of Clinical Trials for Pharmaceuticals
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

M4Q (R2): Revision of "Common Technical Documents - Guidelines for the preparation of quality-related documents
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

M10: Validation of Methods for Analyzing Drug Concentrations in Biological Samples
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

Q5A (R2): Revision of "Viral Safety Assessment of Biotechnology Medicinal Products Produced Using Human or Animal Cell Lines
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

Q9 (R1): Revision of "Guidelines for Quality Risk Management
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

Q13: Serial Production of Active Pharmaceutical Ingredients and Drug Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

S1B (R1): Addendum to Guidelines for Carcinogenicity Studies of Pharmaceuticals

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.

M10: Validation of Methods for Analyzing Drug Concentrations in Biological Samples
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

M8: Q&A on "eCTD (Electronic Common Technical Document) v4.0 Electronic Specification" v1.7 and eCTD v4.0 Implementation Guide v1.5

Reached Step 2

M12: "Drug Interactions" was reported to have 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 that will develop guidelines in the future.

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 the understanding of not only those involved but also the general public. The outcomes of the ICH Athens meeting, concept papers and work plans for each topic are available on the ICH website ( https://www.ich.org/ ).