In our previous blog, we explored the birth of the International Council for Harmonization (ICH). But the work of ICH goes far beyond its formation. Its core purpose is to promote public health through international harmonization. This is achieved by developing technical guidelines that help prevent unnecessary duplication of clinical trials and post-market evaluations, support the development and supervision of new medicines, and reduce animal testing without compromising safety or effectiveness¹.
These guidelines are implemented by regulatory authorities around the world. Yet, for such global collaboration to function effectively, ICH requires a transparent and impartial framework—especially because it must align interests of its two key stakeholders: regulators and the pharmaceutical industry. Regulators are focused on ensuring patient safety and compliance, while the industry seeks to innovate and bring treatments to market efficiently. These two groups, typically operating on opposite sides, have come together through ICH to work collaboratively in ensuring both safety and progress. Balancing these interests is essential—and the structure of ICH is designed to maintain that balance.
For clinical professionals, knowing how ICH guidelines are developed adds depth to everyday tasks. It connects routine decisions—like managing deviations or interpreting protocol changes—to a larger global process designed to protect patients and streamline innovation.
But to truly understand how a guideline takes shape, we first need to know who’s behind it. ICH isn’t a single entity—it’s a framework made up of distinct bodies, each with defined responsibilities. From high-level governance to technical drafting, these groups work together to turn regulatory needs into global standards. Let’s now take a closer look at the key bodies that make up ICH—and how each contributes to its mission.
To understand how ICH operates, it is essential to recognize the main bodies that form its organizational structure. ICH is composed of four core bodies, each with distinct roles and responsibilities. Together, they ensure that ICH can effectively coordinate and oversee the harmonization of global clinical research practices. These bodies are:
- The Assembly
- The Management Committee
- The MedDRA Steering Committee
- The Secretariat
- The Auditors
This diagram shows how the main bodies of ICH are connected, with the ICH Assembly at the center of governance. It coordinates closely with the Management Committee, Secretariat, ICH Working Groups, and MedDRA Steering Committee to ensure strategic and operational alignment.
](https://icrla.com/wp-content/uploads/2025/06/Structure-of-ICH-Association-1024x757.jpg)
Source: ICH. View original
The Assembly is the highest governing body of ICH and is composed of all Members of the Association. It holds ultimate decision-making authority and ensures that the organization remains aligned with its mission of global harmonization in clinical research.
As the central governing forum, the Assembly oversees the strategic direction of ICH, manages membership decisions, and supervises the other ICH bodies to ensure effective collaboration and accountability.
Key responsibilities of the Assembly include:
- Governance – Setting the strategic direction of ICH
- Membership Management – Approving or rejecting membership and observership applications; excluding members when necessary
- Management Committee Oversight – Appointing or dismissing representatives on the Management Committee
- Auditor Oversight – Appointing and dismissing ICH Auditors
- Approvals & Rejections – Voting on financial matters, guideline adoption, and other organizational decisions
- Any Other Business (AOB) – Addressing other issues explicitly reserved for Assembly decision
📌 Note: The Articles of Association take precedence over the Rules of Procedure of the Assembly (RoP) in case of any conflict.
→ See the Key ICH Documents section for more details.
The Management Committee (MC) is composed of Permanent and Elected Management Committee Representatives, both of whom are appointed by the Assembly as defined in the Articles of Association. This body oversees the operational, strategic, and financial execution of ICH’s mission.
Key Responsibilities of the Management Committee:
- Voting – Participates in decision-making processes as outlined in the Articles of Association
- Meetings – Attends and contributes to both MC and Assembly meetings
- Director Oversight – Oversees the Director’s performance and responsibilities
- No Compensation – As per Article 39, MC members do not receive compensation for their roles
Competencies of the Management Committee
The Management Committee oversees ICH’s operations and strategic direction. Its competencies can be grouped into two categories:
Operational Competencies:
- Assembly Operations – Organizing and preparing for Assembly meetings
- Director Oversight – Appointing and supervising the Director
- Working Group & Process Oversight – Ensuring the timely progress and quality of ICH guidelines
- MedDRA Oversight – Supervising the MedDRA Steering Committee and setting its priorities
- Sub-committees & Working Groups – Establishing and managing these as needed
Administrative Competencies:
- Strategic Planning – Proposing annual and multi-year strategic plans
- Representation – Designating individuals to represent ICH externally
- Guideline Proposals – Submitting new or amended guideline topics for consideration
- Financial Oversight – Managing membership fees, budgets, and financial contributions
- Insurance – Ensuring Director & Officer (D&O) and commercial liability insurance
- Annual Financial Reports – Reviewing and submitting audited financial statements to the Assembly
The MedDRA Steering Committee
The MedDRA Steering Committee is a specialized body within ICH responsible for overseeing the development, maintenance, and global use of the Medical Dictionary for Regulatory Activities (MedDRA). It ensures that MedDRA remains a consistent, reliable, and harmonized terminology for use in clinical trials, pharmacovigilance, and regulatory submissions.
Composition:
The committee includes representatives from the ICH Management Committee (MC), including:
- Founding Regulatory Members
- Founding Industry Members
- Standing Regulatory Members
- The Medicines and Healthcare products Regulatory Agency (MHRA)
Additional members may be appointed by the Management Committee in consultation with the MedDRA Steering Committee.
Term of Office:
Most representatives serve indefinitely, although certain regulatory and industry representatives may have terms defined by the Management Committee.
Observer Status:
The World Health Organization (WHO) holds observer status on the MedDRA Steering Committee. This means they may participate in discussions but do not have voting rights.
The ICH Secretariat is the operational backbone of the organization. It supports the Management Committee, sub-committees, and working groups by coordinating day-to-day activities and ensuring smooth execution of ICH’s global functions.
Composition:
The Secretariat is made up of professional staff who are not Members of ICH. They are appointed and remunerated by the ICH Association. The Secretariat is led by a Director, who is appointed by the Management Committee and oversees its operations.
Functions and Responsibilities:
- Day-to-Day Management – Coordinating daily activities and ensuring operational continuity
- Representation – Representing ICH externally, under delegation from the Management Committee
- Budget and Coordination – Assisting with budget preparation and logistical support across ICH activities
- Support for MedDRA – Providing operational support for the development and maintenance of MedDRA
Location:
The ICH Secretariat is based in Geneva, Switzerland, and serves as the central hub for ICH’s global operations.
The Assembly is responsible for appointing an independent auditing firm to serve as the Auditors of ICH. Auditors are appointed for a two-year term, with the possibility of reappointment. The Assembly also retains the authority to dismiss the Auditors at any time. This oversight ensures transparency, financial integrity, and accountability in the financial operations of the ICH Association.
- Association: Refers to the ICH as a legal entity, officially known as the “International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,” established under Swiss Civil Code.
- Member: An organization formally admitted to the ICH Association, with voting rights in the Assembly and/or Management Committee.
- Observer: An organization or entity allowed to participate in discussions without voting rights.
- Representative: An individual officially designated by a Member or Observer to participate in ICH activities or governance (e.g., Assembly, Management Committee).
- Articles of Association: The foundational legal document that defines the formation, structure, and rules of the ICH Association.
- Rules of Procedure (RoP): Internal governance rules that define how each ICH body (e.g., Assembly, Management Committee) operates in practice.
- SOP (Standard Operating Procedure): A procedural guide for ICH Working Groups, including how technical guidelines are developed and maintained.
Articles of Association : The legal foundation of ICH; defines its purpose, structure, membership, and powers.
Rules of Procedure of the Assembly (Assembly RoP) : Explains how the Assembly operates—including meetings, voting, and member rights.
Rules of Procedure of the Management Committee (MC RoP) : Details how the Management Committee functions to oversee daily and strategic operations.
Standard Operating Procedures (SOPs) : Provide step-by-step instructions for how ICH guidelines are developed and how Working Groups operate.
Overview of ICH 2025 (Presentation) : A high-level visual summary of ICH’s mission, structure, and key functions—ideal for quick orientation.
In the next blog, we’ll shift from the structural overview to the people and roles that bring ICH to life. We’ll explore the key roles involved—such as Members, Observers, Representatives, Working Group experts—and how each connects to the Assembly, Management Committee, Secretariat, and other ICH bodies. If you’re a clinical professional, understanding who does what—and how they interact—is key to seeing how your work fits into the broader ecosystem of global harmonization.
Stay with us as we continue the CRLA ICH Essentials Series.
📘 Previously: Why ICH Exists (Blog 1) | How ICH Was Formed (Blog 2)
🧭 Coming Up Next: ICH: The People Behind the Process – Roles That Drive Harmonisation (Blog 4) – coming soon.
- International Council for Harmonisation (ICH). Overview of ICH – 2025 Presentation. Geneva, Switzerland. Available at: https://admin.ich.org/sites/default/files/2025-05/OverviewOfICH_2025_0520.pdf (Accessed June 2025).