International Conference on Harmonization-Good Clinical Practices Update
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INTERNATIONAL CONFERENCE ON HARMONIZATION-GOOD CLINICAL PRACTICES UPDATE BETTEL. BARTON,PHD,MD, FCAP Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
This paper presents an introduction to the “Internotional Conference on Harmonization Good Clinical Practices Consolidated Guideline” for professionals who are already familiar with Food and Drug Administration (FDA) clinical trial standards. A brief background on the International Conference on Harmonization (ICH) is provided. ICHGCP is then compared to FDA standards. ICH guidelines are well supported by industry and FDA. As a result of ICH, regulatory requirements are becoming clearer and more harmonized, the quality of clinical studies is improving, and the acceptance of foreign data is increasing within the ICH regions. Harmonization of the format and content of marketing applications, which is anticipated to be completed in the next few years, will bring more benefits. Key Words: International Conference on Harmonization; Good Clinical Practices; Food and Drug Administration
THIS PAPER introduces the ICH-GCP guideline to professionals who are already familiar with clinical trial standards acceptable to FDA. Those parts of the guideline that superficially may appear different from these familiar standards will be emphasized. Upon careful reading, however, one will find the guideline is consistent with federal laws, FDA regulations, and commonly accepted good clinical trial practices in the United States. A brief background on the ICH is a good place to start a discussion of the “International Conference on Harmonization-Good Clinical Practice: Consolidated Guideline”
Presented at the DIA Workshop “Advanced GCP Workshop: New Techniques,” September 15-17. 1997, Philadelphia, Pennsylvania. Reprint address: Bette L. Banon, FDAICDERIOCI DSIICIB (HRD-344). 7520 Standish Place, Room 125. Rockville, MD 20855.
(ICH-GCP). The United States is party to the General Agreement on Tariffs and Trade (GAT). An important amendment to this international trade agreement, the GATT Agreement on Technical Barriers to Trade (TBT), was negotiated in the 1970s to encourage reduction of unnecessary nontariff barriers to trade. The TBT agreement became law in the United States in 1980 as the Trade Agreement Act. This act directs agencies of the United States government to reduce unnecessary obstacles to foreign commerce by encouraging the use of international standards (eg, guidelines) and by participating in international standards development activities (eg, ICH), but it also directs that the safety and quality standards of the United States for consumers must not be lowered and that harmonization must not be downward. In effect, the Trade Agreement Act authorized FDA to participate in ICH and it set the standards for that participation.
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Bette L Barton
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The purpose of ICH, the ful
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