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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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.

GAO noted that: (1) FDA's MRA implementation plan establishes a framework for making assessments of equivalence of European Union member states; (2) the implementation plan also includes a strategy for making assessments of equivalence and estimating the costs and resources needed to implement MRA; (3) however, FDA has not yet determined how it will use the criteria in the pharmaceutical GMP annex to assess whether the regulatory systems of the European Union member states are equivalent to FDA's regulatory systems; (4) FDA could only provide rough estimates of the costs to negotiate and prepare for the implementation of MRA because it does not maintain a system for tracking the time staff spent on MRA-related activities; (5) according to FDA estimates, FDA will require about $10 million--including the cost of about 125 full-time equivalent employees--during the transition period and first operational year of MRA; and (6) meetings of the committees established to oversee implementation of the pharmaceutical GMP annex and MRA have resulted in the exchange of draft plans for implementing the annex and making assessments of equivalence and clarification of the GMP definition.

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