Topics ICH Incheon Conference" held via web conference

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The International Conference on Harmonization of Pharmaceutical Regulations (ICH) plenary meeting in the first half of 2021 was scheduled to take place in Incheon, Korea. 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), Japan Standard Time. 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. The following are special notes from the Incheon meeting (online).

1. approval of ICH members and observers

The Saudi Food and Drug Administration (SFDA) was approved as a new member of the International Conference on Harmonization (ICH). 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 members (3 regulators and 3 industry members), permanent members (2 regulators), permanent observers (World Health Organization and IFPMA), and elected members (4 regulators and 2 industry members). The elected members are elected every three years, and the election was held this time. As a result, the following members were elected There are four seats for regulators, but only three members are currently in office.

Regulators: Brazil's National Agency for Health Supervision (ANVISA), Korea's Ministry of Food and Drug Safety (MFDS), and China's National Medicines Regulatory Administration (NMPA).
Industry: Biotechnology Innovation Institute (BIO), International Generic and Biosimilar Pharmaceuticals Association (IGBA)

3. developments on 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, Step migration of existing topics and discussion of new topics took place at the Trustees and General Assembly meetings. 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. As a result, it was decided to limit the adoption of new topics to those of high urgency/importance.

Reached Step4

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

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

Q3C (R8): Revision of "Guidelines for residual solvents in pharmaceutical products

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.

M8 eCTD v4.0 Question and Answer (Q&A) Document v.1.5: Revision of "Questions and Answers (Q&A) on "Application for Approval by 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.

Reached Step 2

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

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	S1B(R1): Addendum to "Guidance on Testing for Detecting Carcinogenicity of Pharmaceutical Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	S12: Non-clinical biodistribution studies for gene therapy products

Adoption of new topics

The following items were adopted for the launch of a new working group to develop guidelines in the future. Although adopted, the specific timing of the start of activities will be discussed in the future.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Stability" (Q1) series and related updates to "Stability Studies of Biopharmaceuticals (Biotechnology Products/Products of Biological Origin)" (Q5C)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Updates to "Establishment of Specifications and Test Methods for New Drugs" (Q6A) and "Establishment of Specifications and Test Methods for Biologics (Biotech Products/Biogenic Products)" (Q6B)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	General Principles for the Design and Design of Pharmacoepidemiological Studies Utilizing RWD in Safety Assessment

Movement toward initiation of activities for adopted topics

M4Q (R1) (Revision of CTD quality) was already adopted at the ICH meeting in 2020, but the WG was not established until the achievement of Step 1 of the related Q13 (Continuous production). The team building (selection of experts from each organization) for M4Q (R1) started as that milestone was cleared at the time of the meeting.

4. next ICH meeting

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

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 outcomes 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/ ).