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FDA/Center for Drug Evaluation and Research

International Conference on Harmonization (ICH)
in the Office of Pharmaceutical Science (OPS)

ICH is the shortened name for The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH works to bring together government regulators and drug industry representatives from the U.S., the European Union, and Japan to make the international drug regulatory process more efficient and uniform. This work will help make new drugs available with minimum delays to both American consumers and those in other countries. This unique undertaking is focused to reduce the need to duplicate the testing conducted during the research and development of new medicines.

The drug regulatory systems in all three regions share the same fundamental concerns for the safety, efficacy, 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. Through harmonization of the technical guidelines and requirements under which drugs for human use are approved within the participating nations, ICH members seek more economical use of human, animal and material resources and the elimination of delay in availability of new drugs, while maintaining the quality, safety and effectiveness of regulated medicines.

Some ICH projects include:

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 scientific reviews and marketing. It will be particularly critical in the electronic transmission of adverse event reporting and coding of clinical trial data. FDA is already using MedDRA in its Adverse Events Reporting Systems (AERS).
Common Technical Document (CTD). This document will provide an international standard format for submitting safety and efficacy information about a new drug.

As a Center within FDA, CDER, along with the Center for Biologics Evaluation and Research (CBER) and other Centers, is an active participant in the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH). The Office of Pharmaceutical Science (OPS) maintains active representation on behalf of CDER in various "Quality" topics within the International Conference on Harmonization. Most recent efforts have focused on Pharmaceutical Development (Q8), Risk Management (Q9), Quality Systems (Q10), and the Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions (Q4B) topics.

Information on this international initiative is available through the official ICH Home Page on the World Wide Web. The ICH Secretariat maintains this web site and is responsible for the accuracy of the information it contains. In addition, CDER's Office of Training and Communications, through its Drug Information Branch, makes available a current list of ICH guidance documents. If you access this page, scroll down to the section entitled International Conference on Harmonisation. Also, information regarding many of FDA's international activities will soon be available via the FDA web site.

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Date created: February 6, 2006, updated January 28, 2008