Topics The 5th ICH Forum: ICH Quality Guideline Update
On December 13, 2023, the "5th ICH Forum: ICH Quality Guideline Update" was held jointly by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the Pharmaceutical Manufacturers Association of Japan (PMAJ). This forum was held to discuss the ICH Quality Guideline Update (QGuideline), Q2 (R2) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the ICH Quality Guideline Update (QGuideline). This forum focused on the Q Guidelines (Quality Guidelines) of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), including the Q2(R2)/Q14 Guidelines (Revision of Analytical Method Validation and Method Development), the Q5A(R2) Guidelines (Viral Safety Evaluation of Biotechnology-based Pharmaceuticals Produced Using Human or Animal Cell Lines), the Q9(R1) Guidelines (Quality Risk Management), and the Q13 Guidelines (Quality Management). Experts involved in the revision and development of the Q9(R1) Guideline (Quality Risk Management) and the Q13 Guideline (Serial Production of Active Pharmaceutical Ingredients and Dosage Forms) provided an overview of their work, followed by a panel discussion on the latest science and risk perspectives. In addition, two Japanese recipients of the ICH Award, which recognizes experts who have contributed to the review of the ICH Guidelines, were presented with commemorative gifts.
Outline of the Meeting
ICH supports training initiatives online and in each ICH region to promote understanding of the ICH Guidelines among stakeholders. This forum was also held as part of stakeholder engagement efforts in Japan, co-hosted by the Ministry of Health, Labour and Welfare (MHLW), PMDA, and the Pharmaceutical Manufacturers Association of Japan (PMAJ) under the auspices of the ICH Foundation. This year's forum was the fifth such event.
As shown in Table 1, the forum consisted of lectures and panel discussions on each guideline from the morning to the afternoon. The ICH Awards ceremony was held at the beginning of the morning, followed by a panel discussion on the overview of the latest ICH trends and a lecture by Yoshihiro Matsuda of PMDA on the latest trends and prospects of ICH Q guidelines. Then, after a break, experts from each working group introduced the status of ICH Q13, ICH Q5A, ICH Q9 (R1), and ICH Q2 (R2)/Q14, which have reached Step 4. Finally, a panel discussion was held in the form of receiving the contents of the prepared guidelines.
This forum was held in a hybrid format with on-site and online participation at the Tokyo Conference Center, Shinagawa (Minato-ku, Tokyo), where questions could be asked in advance and on the day of the forum. Please refer to https://www.pmda.go.jp/int-activities/symposia/0140.html for the presentation materials.
Table 1 Program
ICH Awards Ceremony
The "ICH Award" was established in 2022 to recognize experts who have made significant contributions to the study of the ICH Guidelines. Two Japanese experts received the award, and a commemorative plaque from ICH was presented to the winners through Mr. Yoshinori Yoshida, Deputy Director-General, Minister's Secretariat, Ministry of Health, Labour and Welfare. The award was presented to Mr. Shigeru Hisada, who served as the topic leader of ICH S1B (R1), the Committee for the Evaluation of Pharmaceuticals until 2023, as an official of the Pharmaceutical Manufacturers Association of Japan.
ICH Awards Ceremony
Panel Discussion
Overview of ICH Latest Developments
The morning panel discussion focused on the current status and challenges of ICH. The panel discussion topics included the expansion of ICH membership not only to developed countries but also to emerging countries, and the associated importance of training and efficient operation of working groups.
The panelists then discussed the importance of training materials and the evaluation process of training, etc. The discussion was then followed by a presentation by Masashi Yokota, Chairperson of the ICH Project Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ). The panelists then discussed the importance of training materials and the evaluation process of training.
Regarding efficient working group operations, cost consciousness regarding ICH operations in light of the post-Corona and the challenges to conducting efficient discussions were raised. Dr. Manabu Yanagisawa, Vice Chair of the ICH Project Committee of the Pharmaceutical Association of Japan (PAK), presented the message that the PAK should maintain its presence as a founding industrial organization and contribute to the discussions of the working group, so that activities in the PAK will lead to the world.
Panel discussion in the morning
Drug development based on the latest science and risk (in terms of ICH Q guidelines)
In the afternoon, a panel discussion was held on the theme of "Prospects and challenges for practical application of continuous production, quality risk communication between companies and regulatory authorities, and expectations and challenges for Analytical QbD". Since the four topics addressed reached Step 4 at the same time, the discussion focused on the following four themes.
| (1) | Continuous production and analytical QbD Expectations for the new guidelines |
| (2) | Challenges of the new guidelines |
| (3) | On Quality Risk Communication |
| (4) | Toward the Penetration of the ICH Guidelines |
The experts who participated in the panel discussion carefully explained the background behind the creation of the guidelines, and noted that although the guidelines are conceptual in nature, the fact that they were issued as a document made it easier for companies to take on the challenge of introducing them, and that in the area of quality, while new methods are being developed and technology is advancing, there are still many issues that need to be addressed by regulatory authorities and the industry. In the area of quality, while new methods are being developed and technology is advancing, communication between regulatory authorities and industry has not been smooth, and as one means of resolving this issue, it is hoped that the verbalization of the guidelines will facilitate communication.
Panel discussion in the afternoon
Summary
During the lecture and panel discussion, the background and content of the new guidelines were explained, and the implementation (training) of the new guidelines was discussed.
One common comment made by the experts who prepared the guidelines was that "when attempting to include detailed descriptions, including examples, in the guidelines, the volume of the guidelines themselves often becomes too large to write. Therefore, as a result, the descriptions in the guidelines themselves are often simple and conceptual. As a supplement to the descriptions, many working groups work to create training materials after the guidelines are created. One of the most memorable points made by the participants was that "the creation of the guidelines does not solve everything, but it is important to consider that the guidelines have created a foundation for discussion between regulators and industry, and it is important to communicate with each other.
Several regulatory experts also commented, "New technologies cannot be developed by one company alone. We would like to promote discussions across the industry. There is also knowledge that should be shared (things that cannot be solved by the company alone), so we would like you to strategically disseminate various information to make the public aware of new technologies". ICH project committee member Tsuyoshi Kobayashi
( Tsuyoshi Kobayashi, ICH Project Committee)