Mutual Recognition Agreement: Update on the Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Good Manufacturing Practice Regulatory Systems

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.