Topics The 4th ICH Forum: ICH Efficacy Guideline Update

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On December 8, 2022, "The 4th ICH Forum: ICH Efficacy Guideline Update" was held jointly by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), and the Pharmaceutical Manufacturers Association of Japan (PMAJ). This forum was held to discuss the ICH Efficacy Guideline Update (EGuideline) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is one of the ICH E8000 guidelines. The forum was organized by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and included the ICH E8(R1) General Guidelines for Clinical Trials, ICH E6(R3) Good Clinical Practice (GCP) for Pharmaceutical Products, ICH E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre- or Post-Approval The panel discussion focused on ICH E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre- or Post-Approval Clinical Trials (Optimization of Safety Data Collection), and the latest developments in ICH and expectations and desires for the future. In addition, five Japanese recipients of the "ICH Award," which recognizes experts who have contributed to the review of 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 to each stakeholder. This forum was also held as part of the Stakeholder Engagement initiative in Japan, co-hosted by the MHLW, PMDA, and the Pharmaceutical Manufacturers Association of Japan (PMAJ) under the auspices of the ICH Foundation.

The morning session began with a keynote speech by PMDA President Yasuhiro Fujiwara, followed by the ICH Awards ceremony and a panel discussion on the latest ICH trends. In the afternoon session, Mr. Tomonori Ando of PMDA gave a lecture on the latest trends of ICH E-Guideline, and experts from each working group introduced the status of E8 (R1) and E19, which have reached Step 4, and E6 (R3), which is now under consideration for Step 2. In review, Mr. Kazuhiko Mori, Executive Director of the Pharmaceutical Manufacturers Association of Japan, gave a lecture on the E-Guideline as a whole. Finally, a panel discussion was held in response to the presentations.

The forum was held in a hybrid format with on-site and online participation at AP Hamamatsucho (Minato-ku, Tokyo), where questions were accepted in advance and on the day of the forum. Please refer to https://www.pmda.go.jp/int-activities/symposia/0126.html for the presentation materials. This report focuses on the afternoon session.

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. 12 people (3 from the regulatory side and 2 from the industry side from Japan) received the award in the first year, and a commemorative plaque was presented by ICH through Mr. Fumi Yamamoto, Deputy Director General, Minister's Secretariat, Ministry of Health, Labor and Welfare. The two winners from the industry side were Yasushi Komiyama, Vice Chairman of the Data Science Subcommittee of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan, and Tomonori Nakagawa, Group Leader of the ICH Quality Group of the Quality Committee.

Recent Developments in ICH E-Guidelines

Dr. Tomonori Ando, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

During the call for public comments during the revision of ICH E6 (R2) (2016), an international consortium and others submitted to the European Medicines Agency (EMA) and ICH an Open The following GCP Renovation (revision of standards for the conduct of clinical trials of medicinal products) is now underway.

In addition to E8, E6, and E19, which were introduced at this forum, other E-guidance under consideration will be further discussed in the future in the preparation and revision of E-guidelines to further improve efficiency and appropriateness of drug development and methods for this purpose. Under the policy that what is presented in the guideline is basically a principle, the message was presented that in addition to the importance of implementing communication with the authorities from an early stage, it is also important to understand the stated language, including its intent, and the period of time required for its dissemination and discussion.

ICH E8 (R1) (Revised general guidelines for clinical trials)

(Independent Administrative Institution, Pharmaceuticals and Medical Devices Agency )

The following key points of this revision of E8 were explained.

In particular, the Quality by Design approach aims to actively improve quality by building study quality into study protocols and procedures, and to take a risk-based approach to CTQ factors by focusing on critical to quality factors (CTQ factors). He explained the importance of managing risks to CTQ factors through a risk-based approach focused on critical to quality factors (CTQ factors).

He also stated that E8 may be difficult to understand because of its conceptual nature, but a domestic notice was issued on December 23, 2022 as "Revision of the General Guidelines for Clinical Trials," and he asked everyone to take this opportunity to review it again.

ICH E6 (R3) (Revised Standards for the Conduct of Clinical Trials of Drugs)

(Independent Administrative Institution Pharmaceuticals and Medical Devices Agency) Dr. Izumi Ohba

He explained that the purpose of this revision of E6 is "to revise the current ICH E6 (R2) guideline following the modernization of ICH E8 as a series of GCP Renovation tasks in order to respond to the diversification of clinical trial designs and data sources. In addition, "Overarching Principles and Objectives" will replace the current R2 guideline, and "Annex 1-Interventional clinical trails" will be revised to "Annex 2-Additional considerations". It was also explained that "Annex 1-Interventional clinical trails" will be replaced by "Annex 2-Additional considerations for non-traditional interventional clinical trials".

The guideline revision work is being conducted while holding regular Stakeholder Engagement Sessions where the working group exchanges opinions with each stakeholder, mainly academia, so that more opinions are heard from each stakeholder prior to Step 2 than in the usual guideline development process. Therefore, it was reported that the timeline has been delayed due to the many comments received from stakeholders prior to Step 2, rather than the usual guideline development.

ICH E19 (A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials)

Dr. Kinue Nishioka, Pharmaceuticals and Medical Devices Agency, Japan

First, he stated that the title of this guideline was changed when it became Step 4 to make the content easier to understand, and then he explained the contents of this guideline.

The "selective safety data collection" in this guideline is intended to reduce certain types of data collection in certain late-stage clinical trials before or after approval, but first, the safety profile of the drug must be well characterized, does it serve the purpose of the clinical trial, etc., etc. The first step is to consider whether the safety profile of the drug is well characterized and whether it is consistent with the objectives of the clinical trial. Then, if selective collection is appropriately justified and well designed, it should be conducted as a clinical trial utilizing selective safety data collection, which is recognized by numerous regulatory authorities, and as a method that can facilitate the conduct of large-scale clinical trials of efficacy and safety to answer important scientific questions. The message was expressed that the Guidelines should be used as a tool to facilitate the conduct of large scale clinical trials of efficacy and safety to answer important scientific questions.

Summary

In this lecture and panel discussion, the past activities of the ICH and the future prospects of the ICH were explained and discussed not in terms of individual guidelines, but in terms of the efficacy guidelines as a whole and the communication between the ICH and external stakeholders. The ICH, which at its inception consisted of regulators and industry associations from Japan, the U.S., and Europe, now has a total of 56 organizations, and its scope of influence has expanded.

By promoting collaboration with external stakeholders, the importance of promoting drug development in a more efficient and optimal manner has also come to be considered in each guideline. In addition, the environment surrounding drug development has drastically changed due to the new coronavirus infection (COVID-19), and guidelines related to this are being revised appropriately.

As mentioned above, our daily activities as ICH were made known once again through this forum. However, since the establishment of guidelines inevitably takes time and the situation changes depending on the purpose of the drug product to be developed, we felt once again that it is essential to proceed in an appropriate manner according to the situation while maintaining close communication with the regulatory authorities, while following the guidelines as a general rule.

( Machiko Kaku, ICH Project)

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