Topics ICH Incheon Meeting" was held.

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The International Conference on Harmonization of Pharmaceutical Regulations (ICH) for the second half of 2022 was held in Incheon (Korea) from November 12 to 16. Although the meeting was held in principle as a face-to-face meeting, online participation was also available for participants who were unable to travel due to the new coronavirus infection (COVID-19).

Scene of the meeting Scene of the meeting

The meeting included the preparation of proposals to be made and discussed at the General Assembly, the Management Committee responsible for the operation of the ICH, and the General Assembly with the participation of all members. In addition, discussions in the 10 expert working groups (working groups) that examine technical guidelines were held in parallel at the same time to make progress in the preparation of ICH guidelines. At this meeting, the serial production of Q13 APIs and formulations reached Step 4. Although the size of the meeting is smaller than in the past, we are gradually returning to the operation of ICH meetings prior to the COVID-19 epidemic.

The Incheon meeting was attended by 24 organizations, including 6 industry-government organizations, 2 permanent members, 12 member organizations, 2 permanent observers, and other observer organizations from the founding member countries of Japan, the U.S., and the EU. More than 280 participants from around the world attended the local Incheon meeting, including 24 from the Pharmaceutical Manufacturers Association of Japan.

The following is a list of special notes from the Incheon meeting.

1. admission of new observers

The Tunisian Drugs and Medicines Administration (DPM) was approved as a new observer to the ICH. As a result, the number of ICH members and observers increased by 20 and 1, respectively, to 36 organizations, bringing the total number of ICH organizations to 56 (see the reference material at the end of this document).

2. trends in ICH technical topics

At the Incheon meeting, working groups on a total of 10 topics held active discussions and made progress.

Expert Working Groups with meetings

Q1/Q5C informal WG: Targeted Revisions of the ICH Stability Guideline Series
Q3E EWG: Evaluation and Control of Drug Product and Biologics Eluates and Effusions
Q9(R1)EWG: Revision of "Guidelines for Quality Risk Management
Q13 EWG: Serial Production of Active Pharmaceutical Ingredients and Dosage Forms
E2D(R1)EWG: Revision of "Handling of Post-approval Safety Data
E6(R3) EWG: Revision of "Standards for Conducting Clinical Studies on Drugs
E11A EWG: Extrapolation in pediatric drug development
M4Q (R2): Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documentation
M13A EWG: Bioequivalence Studies for Immediate Release Oral Solid Dosage Forms
M15 informal WG: General Principles for Model-Informed Drug Development

Q1/Q5C and M15 are new working groups established in 2022.

Step 4 reached

Step 4 was reported to the General Assembly for the continuous production of Q13 API and drug product. It will now enter the process of implementation in the respective regulatory authorities.

In addition, the Trustees and the General Assembly also discussed the progress management of all existing topics. The following topics were reported to have reached important milestones since the last ICH Athens meeting.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E19: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (Step 4 reached in September 2022) Step 4 reached)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	S1B (R1): Addendum to "Guidelines for Carcinogenicity Studies of Drugs" (Step 4 to be completed by August 2022)

Step 2 reached

The following topics will now be open for public comments in each country/region.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M11: Clinical electronic Structured Harmonized Protocol (CeSHarP) (Reach Step 2 in September 2022)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q5A (R2): Revised Viral Safety Assessment of Biotechnology Medicinal Products Produced Using Human or Animal Cell Lines (Step 2 to be reached in September 2022)

ICH Awards

The ICH Award, which recognizes experts who have made significant contributions to the study of the ICH Guidelines, will be launched in 2022, and 12 people received the award in 2022. From Japan, three winners from the regulatory side and two winners from the industry side were selected for their important leadership and sustained contributions to the ICH working groups. The first two recipients from the industry side were Yasushi Komiyama, Vice Chairman of the Data Science Subcommittee of the Drug Evaluation Committee, and Tomonori Nakagawa, Group Leader of the ICH Quality Group of the Quality Committee, both from the Pharmaceutical Manufacturers Association of Japan.

4. next ICH meeting

The meeting is scheduled to be held in Vancouver (Canada) from June 9 to 13, 2023. The next meeting is also scheduled to be held in person.

ICH actively discloses information on ICH activities, including the outcomes of ICH meetings, to deepen understanding of ICH activities among the general public as well as related parties. The outcomes of the ICH Incheon Meeting, concept papers on each topic, work plans, etc. are available on the ICH website ( https://www.ich.org/ ).