International Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organisation that brings together regulatory authorities and the pharmaceutical industry to harmonise scientific and technical requirements for pharmaceutical product development and registration.

ICH develops harmonised guidelines intended to support the development and registration of medicines that meet appropriate standards of quality, safety and efficacy.

From International Conference to International Council

ICH was established in 1990 as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

In 2015, ICH underwent organisational reform and became the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, established as a non-profit legal entity under Swiss law.

The abbreviation ICH was retained. Therefore, older regulatory documents and educational materials may refer to the International Conference on Harmonisation, while current references use International Council for Harmonisation.

Objectives of ICH

ICH promotes greater harmonisation of pharmaceutical regulatory requirements across different regions.

Its work aims to:

• Promote harmonised scientific and technical requirements for medicines.
• Reduce unnecessary duplication during pharmaceutical development.
• Support efficient development and regulatory assessment of medicines.
• Encourage consistent regulatory standards across participating regions.
• Support the development and availability of safe, effective and high-quality medicines.
• Facilitate international exchange of regulatory information.

ICH Guidelines

ICH Guidelines are organised into four principal categories:

Quality (Q)

Quality Guidelines address areas associated with pharmaceutical development, manufacturing and quality control. Topics include stability, impurities, pharmaceutical development, quality risk management and pharmaceutical quality systems.

Safety (S)

Safety Guidelines primarily address non-clinical safety evaluation. They cover areas such as carcinogenicity, genotoxicity, reproductive toxicity, toxicokinetics and other aspects of non-clinical safety assessment.

Efficacy (E)

Efficacy Guidelines address the design, conduct, safety and reporting of clinical trials and related aspects of clinical development.

Important examples include guidelines covering Good Clinical Practice (GCP), clinical study reports, statistical principles for clinical trials and clinical safety data management.

Multidisciplinary (M)

Multidisciplinary Guidelines address topics that do not fall exclusively within the Quality, Safety or Efficacy categories.

Examples include the Common Technical Document (CTD), Electronic Common Technical Document (eCTD) and Medical Dictionary for Regulatory Activities (MedDRA).

Development and Implementation of ICH Guidelines

ICH Guidelines are developed through a structured, consensus-based process involving experts from regulatory authorities and industry.

For a new harmonisation topic, the formal ICH process progresses through stages of consensus building, regulatory consultation, adoption and implementation.

At Step 4, the ICH Assembly adopts the final harmonised guideline. At Step 5, individual regulatory members implement the guideline according to the applicable regulatory procedures within their respective countries or regions.

This means that an ICH Guideline should be considered together with its implementation status and applicable national or regional regulatory requirements.

Importance of ICH

ICH has played a major role in the international harmonisation of pharmaceutical regulation.

Its guidelines provide common scientific and technical standards across important areas of pharmaceutical development and regulation, helping reduce unnecessary duplication and supporting more consistent regulatory submissions and assessments.

ICH continues to develop and revise guidelines as pharmaceutical science, technology and regulatory requirements evolve.

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