Topics. The 5th ICH Forum: ICH Quality Guideline Update
On December 13, 2023, the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the JPMA jointly hosted the "5th ICH Forum: ICH Quality Guideline Update. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q-Guideline (Quality Guideline) was discussed at this forum. Q2 (R2)/Q14 Guideline (Revision of "Validation of Analytical Procedure" and "Analytical Procedure Development"), the Q5A(R2) Guidelines (Viral Safety Evaluation of Biotechnolgy Products Derived from Cell Lines of Human or Animal Origin), Q9 (R1) Guideline (Quality Risk Management) and Q13 Guideline (Continuous Manufacturing of Drug Substances and Drug Products), as well as an overview of the latest scientific and technical developments. In addition, a panel discussion was held 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 event
ICH supports training initiatives online and in each ICH region to promote understanding of the ICH Guidelines to each stakeholder. This forum was also held as part of the stakeholder engagement efforts in Japan, co-hosted by the MHLW, PMDA, and JPMA through 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 Awards were established in 2022 to recognize experts who have made significant contributions to the study of the ICH Guidelines, and this was the second year of the awards. Two Japanese experts received the award, and a commemorative plaque from ICH was presented to the winners through Dr. Yasunori Yoshida, Deputy Director-General, Minister's Secretariat, Ministry of Health, Labour and Welfare. The JPMA's official recipient of the award was Shigeru Hisada, who served as the Topic Leader of the Drug Evaluation Committee ICH S1B (R1) until 2023.
The ICH Awards ceremony
Panel Discussion
Overview of ICH Latest Developments
In the morning panel discussion, participants discussed the current status and issues of ICH. The panel discussed the importance of training and efficient operation of working groups as ICH membership expands not only in developed countries but also in emerging countries.
In the training session, Masashi Yokota, Chairperson of the JPMA ICH Project Committee, gave an overview of the training program, including the enhancement of public information sessions, diversification of training tools, and outsourcing of training to training associates. 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 issues to be addressed for conducting efficient discussions were raised. Manabu Yanagisawa, Vice Chairperson of the JPMA ICH Project Committee, presented the message that the JPMA should maintain its presence as a founding industry organization and contribute to the discussions of the working group, so that the activities of the JPMA will lead to the world.
The morning panel discussion
Drug Development Based on the Latest Science and Risk (from the Perspective of ICH Q Guidelines)
In the afternoon panel discussion, the theme of the discussion was "Prospects and challenges for practical application of continuous production, and quality risk communication between companies and regulatory authorities, 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) | Expectations for new guidelines for continuous production and analysis QbD |
| (2) | Issues of the new guidelines |
| (3) | Quality Risk Communication |
| (4) | Toward the Penetration of the ICH Guidelines |
The experts who participated in the panel discussion carefully explained the background of 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 while new methods have been developed and technology has advanced in the quality area, communication between the regulatory authorities and industry has not progressed smoothly. As one of the means to solve this problem, it is expected that communication between the regulatory authorities and industry will be facilitated now that the guidelines have been translated into language.
Panel discussion in the afternoon
Conclusion
In this lecture and panel discussion, the background and contents of the new guidelines were explained, and the implementation (training) of the new guidelines was discussed.
One of the common comments made by the experts who prepared the guidelines was that "if we try to include detailed descriptions, including examples, in the guidelines, the volume of the guidelines themselves often becomes too large to write down. 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
( Takeshi Kobayashi, ICH Project Committee)