Topics ICH Fukuoka Meeting held

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The International Conference on Harmonization of Pharmaceutical Regulations (ICH) was held in Fukuoka, Japan, from June 1 to 5, 2024.

Overall photo of the Plenary Meeting Overall photo of the Plenary Meeting

In addition to the Plenary Meeting, which was attended by all ICH members, the Management Committee and other meetings were held to prepare for the discussions to be held at the Plenary Meeting and to consider the operation of the ICH. Thirteen expert working groups (working groups) also met in parallel during the same period to discuss ICH technical guidelines and to make progress on specific guideline documents. The ICH meetings are held twice a year, with on-site participation as a general rule.

The breakdown of participating organizations at the Fukuoka meeting was 6 industry-government organizations*1 from Japan, the U.S., and the EU, which are the founding members, 2 permanent members (Health Canada and Swissmedic), 15 member organizations*2, 2 permanent observers*3, and 17 observer organizations. More than 500 people from all over the world attended the Fukuoka meeting, and 35 people from the Pharmaceutical Manufacturers Association of Japan (PMAJ), including experts from the Working Groups, participated in the Fukuoka meeting.

The following is a list of special notes based on the ICH Management Committee and the ICH General Assembly at the Fukuoka meeting.

1

U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Manufacturers and Associations (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA)
2.

Brazilian National Agency for Health Supervision (ANVISA), Argentinean National Agency for Medicines, Food and Medical Technology (ANMAT), Mexican Federal Commission for Sanitary Risk Control (COFEPRIS), Egyptian Authority (EDA), Health Sciences Authority (HAS) of Singapore, Jordan Food and Drug Administration (JFDA), Korea Food and Drug Safety Agency (MFDS), UK Pharmaceutical and Medical Products Safety Agency (JPMA) (MFDS), UK Medicines and Healthcare products Regulatory Agency (MHRA), China National Medicines Regulatory Administration (NMPA), Saudi Food and Drug Administration (SFDA), Taiwan Food and Drug Administration (TFDA), Turkish Institute for Medicines and Medical Devices (TITCK), Biotechnology Innovation Institute (BIO), Global Self Care Federation (GSCF), International Federation (GSCF), International Generic and Biosimilar Pharmaceuticals Association (IGBA)
3

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), World Health Organization (WHO)

1. new members, observers

The Argentinean authorities (Argentine National Agency for Medicines, Food and Medical Technology (ANMAT)) and the Jordanian authorities (Jordan Food and Drug Administration (JFDA)) submitted applications to become new ICH members, which were approved at the ICH General Assembly. There were no new applications for ICH observer membership.

As a result, there are now 23 ICH members and 35 observers, bringing the total number of ICH members to 58 (see the reference material at the end of this report).

2. trends in ICH technical topics

Working Groups with Meetings

A total of 13 working groups on 13 topics met in Fukuoka. Each working group discussed intensively for four or five days to make progress in the development of the guidelines.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q1/Q5C EWG: Revision of "Guidelines for stability testing of pharmaceutical products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q2 (R2)/Q14 IWG: Revision of "Analytical Method Validation" and "Development of Analytical Methods
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q3E EWG: Evaluation and Control of Extractables and Eluates of Pharmaceuticals and Biological Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q5A (R2) IWG: Revision of "Biopharmaceutical Quality: Viral Validation
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q6 (R1) Informal WG: Revision of "Establishment of Specifications and Test Methods for Pharmaceuticals
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q9 (R1) IWG: Revision of "Guidelines for Quality Risk Management
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E6 (R3) EWG: Revision of "Standards for the Conduct of Clinical Trials of Pharmaceutical Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E20 EWG: Adaptive Clinical Trials
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E21 EWG: Inclusion of Pregnant and Lactating Women in Clinical Trials
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M4Q(R2)EWG: Revision of Common Technical Documents - Guidelines for Quality Documentation
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M11 EWG: Electronically Structured and Harmonized Clinical Trial Protocols
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M13 EWG: Bioequivalence Studies for Immediate Release Oral Solid Dosage Forms
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M15 EWG: General Principles for Model-Informed Drug Development

Topics reaching important milestones

Although no topic reached a step transition during the Fukuoka meeting, the following topics have reached important milestones in ICH in the six months since the ICH Prague meeting in November 2023.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M12: Drug Interaction Studies (Step 4 reached May 2024)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M14: General Principles for Planning and Designing Pharmacoepidemiological Studies Using Real World Data (RWD) in Safety Assessment (Draft) (Reached Step 2 in May 2024)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E2D(R1): Post-approval safety information: Definitions and criteria for handling and reporting individual case safety reports (draft) (reached Step 2 in February 2024)

Reaching Step 2 means that the draft guideline, based on the technical document, has been approved by the regulatory delegates at the Plenary and will now move to Step 3 for public comment by the regional and national regulatory authorities. Reaching Step 4 means that the draft guidelines have been finally agreed upon and adopted by the regulatory representatives of the General Assembly, and the English version of the guidelines has been finalized. The implementation process by regional and national regulatory authorities will now begin.

3. election of ICH Management Committee members 4. adoption of new topics

The ICH Management Committee consists of founding members (3 regulators, 3 industry), permanent members (2 regulators), permanent observers (WHO, IFPMA), and elected members (4 regulators, 2 industry). The elected members are elected every three years, and the election was held this time. As a result of the election, the following organizations were selected as members of the Election Management Committee.

Regulatory Agency:	Brazilian National Agency for Health Supervision (ANVISA), Korea Ministry of Food and Drug Safety (MFDS), China National Medicines Supervision Administration (NMPA), Saudi Food and Drug Administration (SFDA)
Industry: Biotechnology Innovation Institute (BIO), International Generic and Biosimilar Pharmaceuticals Association (IGBA)

4. adoption of new topics 5.

The following topics were adopted as new topics for which guidelines will be developed. The specific timing of the start of activities will be discussed in the future.

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

ICH M7 Guideline Addendum "Risk Assessment and Management of Nitrosamine Impurities"

Adoption of ICH Reflection Paper 6.

At the Fukuoka meeting, a revised reflection paper on "International Harmonization of Terms for Real World Evidence (RWE) Focusing on the Efficacy of Pharmaceuticals and Integration of General Principles for the Planning and Reporting of Studies Using RWD" was reviewed and adopted at the ICH General Assembly.

6. next ICH meeting

The meeting is scheduled to be held in Montreal (Canada) from November 2 to 6, 2024.

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 Fukuoka 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 2024)

Table 1 Members (23 organizations)
front (e.g. of a building, etc.)1　 Members（23 Organization）
(Shaded area in light blue, added at ICH Fukuoka meeting)