The full form of ICH is the “International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.” This body was set up to bring together representatives of the pharmaceutical industry and regulatory bodies to discuss technical and scientific aspects of the registration of drugs. As the pharmaceutical industry grew more international, the differences in technical requirements across countries meant that drug makers had to spend a lot of time and money to duplicate test procedures if they wanted to market their products at an international level. It started becoming important to make safe and effective drugs available to patients all over the world without the delays caused by regulations not matching across regulatory bodies of the different countries. Thus, a need was felt to rationalize and harmonize drug regulations, and this resulted in the inception of ICH in 1990.
The purpose of ICH may be summarized as follows:
• Ensuring quality, safety, and efficacy of drugs.
• Harmonization of drug technical requirements.
• Avoid duplication of human clinical trials.
• Reduce the use of animal testing without compromising on
evaluating the efficacy and safety of drugs.