Topics ICH Vancouver Meeting" held

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The International Conference on Harmonization of Pharmaceutical Regulations (ICH) for the first half of 2023 was held in Vancouver (Canada) from June 9 to 13. Although the meeting was held in principle as an in-person meeting, online participation continued to be available for participants who were unable to travel due to reasons such as new coronavirus infection (COVID-19).

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The meeting included the preparation of proposals to be discussed at the Plenary Meeting, the Management Committee, which is responsible for the operation of the ICH, and the Plenary Meeting, in which all members participate. The ICH meeting has almost returned to its pre-COVID-19 size and operation.

The Vancouver meeting was attended by 6 industry-government organizations*1, 2 permanent members, 12 member organizations*2, 2 permanent observers*3, and 22 other observers from Japan, the U.S., and the EU, all of which are founding members. Approximately 450 people from around the world attended the meeting in Vancouver, doubling the number of participants at the Athens meeting, where face-to-face meetings had just resumed after the Corona disaster. Thirty-two members of the Pharmaceutical Manufacturers Association of Japan (PMAJ) participated in this meeting.

The following are some of the highlights of the Vancouver meeting.

1

U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Manufacturers and Associations (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA)
2.

Brazil's National Agency for Health Supervision (ANVISA), Korea's Ministry of Food and Drug Safety (MFDS), China's National Medicines Regulatory Administration (NMPA), Singapore's Health Sciences Authority (HAS), Taiwan's Food and Drug Administration (TFDA), Turkey's Pharmaceuticals and Medical Devices Agency (TITCK), and Saudi Arabia's Food and Drug Administration (SFDA), Mexico's Federal Commission for Sanitary Risk Preparedness (COFEPRIS), the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), the Biotechnology Innovation Institute (BIO), the International Generic and Biosimilar Pharmaceuticals Association (IGBA), the Global Self-Care Federation (GSCF)
3

World Health Organization (WHO), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

1. new members and observers

The Egyptian Medicines Agency (EDA) was approved as a new member of ICH, the first African regulatory authority to join ICH as a member. In addition, the Nigerian Food and Drug Administration (NAFDAC) was approved as a new observer.

As a result, there are now 21 ICH members and 36 observers, bringing the total number of ICH members to 57 ( see the reference material at the end of this report ).

2. election of Trustee Vice-Chairmen

Following the mid-term retirement of the former Vice-Chair of the ICH Management Committee, an election was held for the remaining term of the Vice-Chair until the fall of 2023, and Mr. Naoyuki Yasuda of the Ministry of Health, Labour and Welfare (currently, Executive Officer, Pharmaceuticals and Medical Devices Agency) was elected.

3. adoption of new topics

At the Vancouver meeting, three new topics were adopted that should be harmonized in the ICH in the future. 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.	General Guidance on Patient Preference Studies
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Non-clinical Safety Studies of Nucleic Acid Drugs
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Bioequivalence of sustained release formulations

4. ICH Reflection Paper

Progress on the following two reflection papers was confirmed.

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

Reflection Paper on "International Harmonization of Real World Evidence (RWE) Terminology Focusing on the Efficacy of Medicinal Products and Integration of General Principles for the Design and Reporting of Studies Using Real World Data (RWD)": Approved by the General Assembly and now available for public comment on the official ICH website. The paper is now available for public comment on the official ICH website.

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

Cell and Gene Therapy Reflection Paper: Based on this reflection paper, which was approved prior to the Vancouver meeting, it was agreed to establish a "Cell and Gene Therapy Discussion Group".

5. trends in ICH technical topics

At the Vancouver meeting, the working groups on all 14 topics had active discussions and made progress.

Working Groups with Meetings

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q1/Q5C EWG: Revision of Stability Testing Guidelines for Drugs
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q2 (R2)/Q14 EWG: Revision of "Analytical Method Validation" and "Analytical Method Development
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceutical and Biological Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q5A (R2) EWG: Revision of "Quality of Biopharmaceuticals: Viral Validation
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q9 (R1) EWG: Revision of "Guidelines for Quality Risk Management
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q13 IWG: Serial Production of Active Pharmaceutical Ingredients and Dosage Forms
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E2D(R1)EWG: Revision of "Handling of Post-approval Safety Data
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E6 (R3) EWG: Revision of "Standards for the Conduct of Clinical Trials of Pharmaceutical Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E11A EWG: Extrapolation in Pediatric Drug Development
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E20 EWG: Adaptive Clinical Trials
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E21 informal WG: Inclusion of pregnant and nursing women in clinical trials
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M4Q(R2)EWG: Revision of Common Technical Documents - Guidelines for Quality Documentation
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M13 EWG: Bioequivalence Studies for Immediate Release Oral Solid Dosage Forms
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M15 EWG: General Principles for Model-Informed Drug Development

No topics reached step transition during this ICH meeting.

The Trustees and the General Assembly also discussed the management of progress and other issues for all existing topics. The following topics were reported to have reached important milestones since the last ICH Incheon meeting

Reached Step4

The final version (in English) has been finalized and will enter the process of implementation in each regulatory authority.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M7(R2): "Guidelines for the Evaluation and Management of DNA Reactivity (Mutagenicity)/Materials in Drugs to Reduce Potential Carcinogenic Risk" and its addendum (April 2023)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	S12: Concept of Non-clinical Biodistribution of Gene Therapy Products (March 2023)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q9 (R1): Revision of "Guidelines for Quality Risk Management" (January 2023)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E2B (R3): Revision of "Questions and Answers (Q&A) on Electronic Transmission of Individual Case Safety Reports" (January 2023)

Reached Step 2

Public comments will be taken in each country/region.

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E6 (R3): Revision of "Standards for the Conduct of Clinical Trials of Pharmaceuticals" (Principles and Appendix 1) (May 2023)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M13A: Bioequivalence study of immediate-release oral solid preparations (December 2022)

6. next ICH meeting

The meeting is scheduled for October 28-November 1, 2023 in Prague (Czech Republic). The next meeting will also be face-to-face.

The ICH is committed to actively disclosing information on its activities, including the outcomes of the ICH meetings, so that not only interested parties but also the general public can deepen their understanding of the ICH. The outcomes of the ICH Vancouver meeting, as well as concept papers and work plans for each topic, are available on the ICH website ( https://www.ich.org/ ).