The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a unique initiative that brings together the pharmaceutical regulatory authorities and the industry from Europe, the United States, and Japan. Its core mission is to achieve greater global harmonization in the interpretation and application of technical guidelines and requirements for developing and registering new medicines.
By creating globally accepted guidelines (known as ICH Guidelines), the organization aims to reduce redundant testing and development work, expedite the availability of new medicines, and reduce the costs of drug development. The guidelines are organized into four main categories: Quality (Q), covering manufacturing and stability testing (GMP); Safety (S), covering nonclinical testing (toxicology); Efficacy (E), covering clinical trial design and reporting (GCP); and Multidisciplinary (M), covering topics like medical terminology (MedDRA). ICH’s work is essential to the global pharmaceutical landscape, creating a common language and standard for drug development across major world markets.
