Topics. ICH Vancouver Meeting Held

PDF for printing

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) held its first half-year meeting for 2023 in Vancouver, Canada, from June 9 to 13. The meeting was held in principle as an in-person meeting, but for participants who were unable to travel due to reasons such as new coronavirus infection (COVID-19), online participation was available as in the past.

Overall Photo Overall Photo

At this meeting, the Management Committee, which is responsible for the preparation of proposals to be discussed at the Assembly and for the management of the ICH, and the Assembly, in which all members participate, were held. 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 Standing Members, 12 Members*2, 2 Standing 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 JPMA members participated in this meeting.

The following is a summary 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

Brazilian National Health Regicines and Medical Devices Agency (ANVISA), Korea Food and Drug Safety Administration (MFDS), National Medical Products Administration (NMPA) of China, Singapore Health Sciences Authority (HAS), Taiwan Food and Drug Administration (TFDA), Turkish Medical Products Administration (TITCK), Saudi Arabia Food and Drug Administration (TFDA), Federal Commission for Protection against Sanitary Risks (COFEPRIS) Mexico, UK Medicines and Healthcare Products Regulatory Agency (MHRA), Biotechnology Innovation Organization (BIO), International Generic and Biosimilar Medicines Association (IGBA), 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 Drug Authority (EDA) was approved as a new member of ICH, making it the first African regulatory authority to join as an ICH member. The Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) was also 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 Vice-Chairman of the Management Committee

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.

•	General Guidelines for Patient Preference Studies
•	Non-clinical safety studies of nucleic acid drugs
•	Bioequivalence of extended-release formulations

4. ICH Reflection Papers

Progress was reviewed on the following two reflection papers.

•

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

•

Cell and Gene Therapy Reflection Paper: It was agreed to establish a "Cell and Gene Therapy Discussion Group" based on this reflection paper, which was approved before the Vancouver meeting. 5.

5. trends in ICH technical topics

During the Vancouver meeting, progress was made through active discussions among the working groups on all 14 topics.

Working groups with meetings

•	Q1/Q5C EWG: Revision of Stability Testing Guidelines for Drugs
•	Q2 (R2)/Q14 EWG: Revision of "Validation of Analytical Procedure" and "Analytical Procedure Development"
•	Q3E EWG: Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products
•	Q5A (R2) EWG: Revision of "Biopharmaceutical Quality: Viral Validation
•	Q9(R1) EWG: "Rivision of "Quality Risk Management"
•	Q13 IWG: Contiuous Manufacturing of Drug Substance and Drug Products
•	E2D (R1) EWG: Revision of “Handling of Post-Approval Safety Data”
•	E6 (R3) EWG: Revision of "Good Clinical Practice"
•	E11A EWG: Pediatric Extrapolation
•	E20 EWG: Adaptive Clinical Trials
•	E21 informal WG: Inclusion of pregnant and breastfeeding individuals in clinical trials
•	M4Q(R2)EWG: Revision of the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
•	M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
•	M15 EWG: General Principles for Model-Informed Drug Development

No topics reached a step transition during this ICH meeting.

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

Step4 reached

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

•	M7(R2): "Guidelines for Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk"
•	S12: Nonclinical Biodistribution Considerations for Gene Therapy Products (March 2023)
•	Q9(R1): Rivision of "Quality Risk Management" (January 2023)
•	E2B (R3): Revision of Electronic Transmission of Individual Case Safety Reports (ICSRs) Questions & Answers (January 2023)

Step2 reached

Public comments will be made in each country/region.

•	E6(R3): Revision of "Guideline for Good Clinical Practice" (Principle and Appendix 1) (May 2023)
•	M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms (December 2022)

6. next ICH meeting

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

The ICH is committed to actively disclosing information on its activities, including the outcomes of the ICH meetings, to deepen understanding of the ICH not only among those involved but also among the general public. The results 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/ ).