ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)

ICH is the shortened name for The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. It works to bring together government regulators and drug industry representatives from the United States, the EU, and Japan to make the international drug regulatory process more effi cient and uniform. This work will help make new drugs available with minimum delays to both American consumers and those in other countries.

The drug regulatory systems in all three regions share the same fundamental concerns for the safety, effi cacy, and quality of drug products. However, many time - consuming and expensive clinical trials have had to be repeated in all three regions. An ICH goal is to minimize unnecessary duplicate testing during the research and development of new drugs. Another goal is to develop guidance documents that create consistency in the requirements for new drug approval. Some ICH projects include the following:

• Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is a new international medical  terminology designed to improve the electronic transmission of regulatory information and data worldwide. It will be used to collect, present, and analyze information on medical products during clinical and scientifi c reviews and marketing. It will be particularly critical in the electronic transmission of adverse event reporting and coding of clinical trial data. The FDA is already using MedDRA in its Adverse Events Reporting Systems.
• Common Technical Document. This document will provide an international standard format for submitting safety and effi cacy information about a new drug.