International Cooperative Efforts The ICH Initiative

The International Conferences on Harmonisation (ICH) represent global collaboration on a larger scale than ever previously attempted by pharmaceutical regulatory authorities. First convened in 1991, ICH programs have focused on development of mutually acceptable guidelines addressing technical requirements for drug testing and registration worldwide. As a result of this work, ICH recommendations have been adopted by many individual national regulatory authorities, making the task of preparing new drug applications by multinational companies much easier. For example, it is now possible to plan just one set of chronic toxicity tests in rodents, because ICH guidelines for the duration of such investigations have been adopted worldwide. Another ICH initiative, the Medical Dictionary for Drug Regulatory Affairs (MedDRA®), has resulted in the development of a standardized vocabulary of terminology for use in regulatory documents. More recently, ICH efforts have concentrated on creating guidelines for a common technical document (CTD), a core information package assembled with uniform format and content specifications that could be submitted for approval to regulatory authorities in any of the top three world drug markets: the United States, the European Union, or Japan.

Databases

International Conferences on Harmonisation. URL: http:// www.ich.org. The ICH Web site provides information on the structure and purpose of this consensus-building initiative, as well as the process for evolving recommendations regarding technical requirements for human drug registration worldwide. Separate sections address existing Guidelines, the Common Technical Document, and MedDRA.

International Conference on Harmonisation. URL: http:// www.fda.gov/cder/audiences/iact/iachome.htm#ICH. This section of the FDA Web site describes the Agency's procedures for dissemination of ICH guidance documents and includes links to pertinent press releases, published reports, meeting transcripts, and Conference presentations by staff.

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