ICH – the global platform for harmonisation
About ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH Guidelines. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.
Purpose
The purpose of ICH is the promotion of public health through international harmonisation that contributes to:
• Reduction of unnecessary animal testing without compromising safety and effectiveness accomplished through technical guidelines implemented by the regulatory authorities
• Prevention of unnecessary duplication of clinical trials and post-market clinical evaluations
• Development and manufacturing of new medicines
• Registration and supervision of new medicines
• Post-authorisation safety reporting and pharmacovigilance
ICH Work
As of November 2021, 67 state of-the-art technical ICH Guidelines and standards have been produced spanning the pharmaceutical products lifecycle, with further guidelines under development. This impressive body of work is categorised along four broad workstreams:
• Quality (Q) - Manufacture, control and stability of products and ingredients
• Efficacy (E) - Design, conduct, safety and reporting of clinical trials
• Safety (S) - Nonclinical test strategies and methods
• Multidisciplinary (M) - Diverse crosscutting topics, including CTD/eCTD, medical dictionary and e-standards for transfer of regulatory information.
In addition, ICH has developed an extensive set of Q&A documents and training materials to further clarify concepts and principles in ICH Guidelines.
Impact of ICH
ICH Guidelines, once implemented by ICH Regulators, form a common backbone of technical requirements across the globe. To achieve the intended effect of promoting a greater level of harmonisation worldwide, the ICH Regulators are expected to implement the ICH Guidelines after they have been adopted by the ICH Regulatory Members. This is also reflected in the Articles of Association as a commitment by ICH Regulatory Members to implement ICH Guidelines - a core operating principle of ICH since its inception. ICH has adopted important measures to ensure a proper interpretation and adequate implementation of ICH Guidelines, many of which present complex scientific concepts and principles. Key among these measures is training. Authoritative ICH-endorsed training materials and courses by accredited non-profit training organisations serve to promote a better understanding and consistent application of ICH Guidelines. Training slide-decks are also now developed for each ICH Guideline. Additional measures include webinars on specific ICH Guidelines, training by ICH Members and Observers, and participation in regional and international events.