Mutual Recognition Agreement: Update on the Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Good Manufacturing Practice Regulatory Systems
HEHS-99-143R
Published: Aug 13, 1999. Publicly Released: Aug 13, 1999.
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Highlights
Pursuant to a congressional request, GAO provided information on the Food and Drug Administration's (FDA) implementation of the mutual recognition agreement (MRA) between the United States and the European Union, focusing on the: (1) progress FDA has made in developing a plan for assessing equivalence of European Union member states' pharmaceutical good manufacturing practice (GMP) regulatory systems; (2) amounts FDA spent, from October 1994 through March 1999, on negotiating and implementing MRA and the amount FDA plans to spend on making assessments of equivalence; and (3) status of the European Union's efforts to coordinate with FDA to implement MRA.
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