Topics "ICH Incheon Conference" to Be Held via Web Conference

Printable PDF

The main meeting of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the first half of 2021 was originally scheduled to take place in Incheon, South Korea. However, in light of the ongoing global COVID-19 pandemic that began in 2020, plans for an in-person meeting were abandoned, and the event will now be held via web conference.This marks the third consecutive online meeting, following the Vancouver meeting in the first half of 2020 and the Athens meeting in the second half of 2020.Since participants were joining from Japan, the U.S., Europe, and Asia, the meeting times were set for the evening in Japan (morning in the U.S., Canada, and Brazil; afternoon in Europe and Africa; and evening to night in Asia). The Management Committee meetings were held on May 25 and June 1, and the Assembly on June 2 and 3, with a two-hour program each day.In addition, discussions by expert and implementation working groups were conducted in parallel via the web during the same period to advance progress on ICH topics. Notable items from the Incheon Conference (online) are listed below.

1. Approval of ICH members and observers

The Saudi Food and Drug Authority (SFDA) was approved as a new member of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The SFDA had previously been an observer organization but was granted full membership status at this meeting.In addition, the Analytical Center of the Ministry of Health of Azerbaijan (AEC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) were approved as new observer organizations.The MHRA had previously promoted ICH activities as part of the European Commission and the European Medicines Agency (EC/EMA), but following the United Kingdom’s withdrawal from the EU, it became necessary for the MHRA to secure a new status as an independent organization.Although there was discussion regarding whether the MHRA should be granted special status to participate as a member in recognition of its contributions since ICH’s inception, it was ultimately decided that it would participate as an observer in accordance with ICH rules.

As a result, the number of ICH members has increased by one from the previous 17 to 18, while the number of observers has increased by two and decreased by one, bringing the total to 33, resulting in an ICH organizational structure comprising 51 entities in total (see reference materials at the end).

2. Election of ICH Management Committee

The ICH Management Committee consists of founding members (three regulatory authorities and three industry representatives), Standing Members (two regulatory authorities), Standing Observers (the World Health Organization (WHO) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)), and Elected Representatives (four regulatory authorities and two industry representatives).Among these, the Elected Representatives are subject to re-election every three years, and that election was held this time. As a result, the following members were elected. Although there are four seats for regulatory authorities, only three members currently hold those seats.

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

3. Trends in ICH topics

The working groups (WGs) for topics that were scheduled to be discussed in person at the Incheon meeting used this time to actively hold web conferences and make progress. In addition, the Management Committee and the Assembly discussed the progression of existing topics to the next phase and deliberated on new topics.It was also noted that, due to the impact of the COVID-19 pandemic over the past year and several months, there has been a general delay in the progress of topics under consideration. Consequently, it was decided that the adoption of new topics would be limited to those of high urgency and importance.

Reaching Step 4

It was reported that the following topics have reached Step 4. These topics will now enter the implementation process with the respective regulatory authorities.

•

Q3C (R8): Impurities: Guideline for Residual Solvents

•

M8 eCTD v4.0 Question and Answer (Q&A) Document v.1.5: Revision of the “Question and Answer (Q&A) Document Regarding ‘Submission of Marketing Authorization Applications Using the Electronic Common Technical Document (eCTD)’”; Specification for Submission Format for eCTD v.1.3:Revision of “Specifications for Electronic Files to be Included 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”

Reached Step 2

Reaching Step 2 has been reported for the following topics. Public comment periods will be held in each country and region going forward.

•	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 in preparation for the launch of new working groups (WGs) that will develop guidelines. Please note that while these topics have been adopted, the specific start dates for their activities will be determined at a later date.

•	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

Progress Toward Launching Activities for 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 meeting is scheduled to take place from November 13 to 17, 2021. Although it was originally planned to be held in Vancouver, Canada, in light of the COVID-19 pandemic, the in-person format was abandoned, and it will be conducted via web conference, following the format of the last three ICH meetings.

ICH actively discloses information regarding its activities, including the outcomes of ICH meetings, to foster a deeper understanding not only among stakeholders but also among the general public. The outcomes of this ICH Incheon Meeting (web conference), as well as concept papers and work plans for each topic, are available on the ICH website (https://www.ich.org/).