Topics. ICH Incheon Conference to be Held in Web Conference Format

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was scheduled to take place in Incheon, Korea, in the first half of 2021. This is the third consecutive meeting to be held online, following the Vancouver meeting in the first half of 2020 and the Athens meeting in the second half. Since participants will come from Japan, the U.S., Europe, and Asia, the meeting will be held in the evening (morning in the U.S., Canada, and Brazil; afternoon in Europe and Africa; and evening or night in Asia), and the Management Committee will meet on May 25 and June 1, and the Assembly on June 2 and 3, with a two-hour program each day. Expert/Implementation Working Group (Working Group) discussions were also held at the same time, each in parallel and in web format, to make progress on ICH topics. Below are some special notes from the Incheon meeting (online).

1. Approval of ICH members and observers

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) approved the Saudi Food and Drug Administration (SFDA) as a new member, having previously been an observer organization. The Azerbaijan Analytical Centre for Health (AEC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) were also approved as new observer organizations. There was some discussion as to whether the MHRA should be allowed to participate in ICH activities as a member in view of its contribution to ICH since its establishment, but in the end the MHRA decided to participate as an observer in accordance with ICH rules.

As a result, the number of ICH members increased by 1 from the previous 17 to 18, and the number of observers increased by 2 to 33, bringing the total number of ICH members to 51 (see the reference material at the end of this report).

2. Election of ICH Management Committee

The ICH Management Committee consists of Founding Regulatory Members (3 from regulatory authorities and 3 from industry), Standing Members (2 from regulatory authorities), Standing Observers (World Health Organization (WHO) and International Affairs Committee (IFPMA)), and Elected Representatives (4 from regulatory authorities and 2 from industry). Elected Representatives are elected every three years, and the election was held this time. As a result, the following members were Elected Representatives. There are four seats for regulators, but only three members are currently in office.

Regulators: Brazilian Health Regulatory Agency (ANVISA), Korea's Ministry of Food and Drug Safety (MFDS), and National Medical Products Administration (NMPA).
Industry: Biotechnology Innovation Organization (BIO), International Generic and Biosimilar Medicines Association (IGBA)

3. Trends in ICH topics

Working groups (WGs) on topics that were scheduled to meet face-to-face at the Incheon meeting took advantage of this period to make progress through vigorous web conferencing. In addition, Management Committee and Assembly meetings were held to discuss Step migration of existing topics and new topics. It was also shared that there has been a general delay in the progress of topics under consideration due to the pandemic of new coronavirus infections over the past year and several months. It was therefore decided to limit the adoption of new topics to those of high urgency/importance.

Reach Step 4

The following topics were reported as having reached Step 4. These are now in the process of implementation by the respective regulators.

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Q3C (R8): Impurities: Guideline for Residual Solvents

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M8 eCTD v4.0 Question and Answer (Q&A) Document v.1.5: Revision of the "Questions and Answers (Q&A) on "Application for Approval via Electronic Common Technical Document (eCTD)"", Specification for Submission Format for eCTD v.1.3: Revision of "Electronic File Specification for Inclusion in the ICH Electronic Common Technical Document (eCTD)" and eCTD v4.0 Implementation Package v.1.4: Revision of "eCTD v4.0 Domestic Implementation Package" amendment.

Step2 Reached

The following topics were reported as having reached Step 2. Public comments will be made in each country/region.

•	S1B(R1): Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals
•	S12: Nonclinical Biodistribution Considerations for Gene Therapy Products

Adoption of new topics

The following topics were adopted for the launch of new WGs that will develop guidelines in the future. Although the topics have been adopted, the specific timing of the start of activities will be discussed in the future.

•	Stability" (Q1) series and related "Stability Testing of Biotechnological/Biological Products" (Q5C) updated.
•	Updates to Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Q6A) and Establishment of Specifications and Test Methods for Biologics (Biotech Products/Biogenic Products) (Q6B).
•	General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines

Movement toward the start of activities for the adopted topics

M4Q (R1) (The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality) had already been adopted at the ICH meeting in 2020, but the establishment of the WG was to wait until the achievement of Step 1 of the related Q13 (Continuous Manufacturing of Drug Substances and Drug Products). The team building (selection of experts from each organization) for M4Q (R1) was started since that milestone was cleared at the time of the meeting.

4. Next ICH meeting

The WG is scheduled to be held from November 13 to 17, 2021. The meeting was planned to be held in Vancouver, Canada, but in view of the impact of the new coronavirus pandemic, the face-to-face meeting format was abandoned and the meeting will be held in the form of a web conference, following the format of the last three ICH meetings.

The ICH actively discloses information on ICH activities, including the outcomes of ICH meetings, to deepen understanding not only among those involved but also among the general public. The results of the ICH Incheon Meeting (Web Conference), concept papers on each topic, work plans, etc. are available on the ICH website (https://www.ich.org/ ).