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Executive Summary

FDA will accept animal test data from the European Community and Japan under a proposed guidance to be published in an upcoming Federal Register. "This will greatly reduce overlapping tests and decrease the cost of product development," HHS Secretary Sullivan stated at an April 9 press conference on implementation of drug approval process reforms proposed by Vice President Quayle's Council on Competitiveness. Harmonization of drug approval requirements was one of 11 reforms recommended the Competitiveness Council in November. A fact sheet issued by the White House says that "under the FDA's new guidance, animal test data developed for foreign countries under consensus standards adopted by FDA and other countries can be accepted for review in the United States, thus eliminating the burden of multiple studies." The harmonization initiative "will reduce the time currently required for long-term testing by six months or more," a same-day FDA release notes. In November, following the first International Conference on Harmonization, the EC announced that the U.S., Japan and the EC had agreed to shorten the repeated-dose safety studies from 12 to six months and standards for determining delayed toxicity and appropriate dosing levels ("The Pink Sheet" Nov. 18, 1991, p. 7). The regulatory bodies also agreed to delete the LD[50] test from animal testing requirements. The fact sheet notes that the guidance is "one of a series of consensus agreements with the European Community and Japan that will harmonize scientific requirements and technical standards and that will reduce the time and resources currently required for drug testing." The guidance "is a first step toward international harmonization and reciprocity of drug approval requirements," the document adds.

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