Mutual Recognition Agreement:

Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Inspection Programs

HEHS-99-71R: Published: Feb 26, 1999. Publicly Released: Feb 26, 1999.

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William J. Scanlon
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Pursuant to a congressional request, GAO reviewed the status of the Food and Drug Administration's (FDA) efforts to implement the mutual recognition agreement (MRA) between the United States and the European Union.

GAO noted that: (1) nearly 3 months into the transition period, FDA does not have a comprehensive plan that identifies the key tasks to complete an equivalency assessment of the European Union member states; (2) in addition, FDA could not provide GAO an update of the estimated costs and resources that will be needed to implement the MRA; (3) GAO found that FDA's current plan establishes an organizational framework, including a steering committee to oversee and coordinate MRA-related activities and a project management team to develop and execute a plan for the conduct of equivalency assessments; (4) the plan also includes an implementation project time line, which provides a schedule of general activities and milestones that FDA anticipates completing during the transition period and through the operational period of the MRA; (5) however, FDA has not yet identified in its plan the information needed to make equivalency determinations, even though the implementation project time line developed in February 1998 required that the plan be completed by July 1998 to prepare the agency for the transition period; (6) FDA did not begin to prepare the plan for making equivalency assessments until January 1999 because staff was involved in other related activities; (7) another reason FDA waited until after the implementing regulations were in place to begin preparing the plan was to avoid the appearance of prejudging the outcome of the formal rulemaking process; (8) FDA has not yet developed a strategic plan that describes the goals of the MRA and how the FDA will measure its performance in achieving those goals; (9) on February 2, 1999, FDA officials told GAO an update of the plan for making equivalency determinations and cost estimates would not be available until March 1999 and the final plan would not be completed and shared with the European Union until July 1999; (10) FDA officials acknowledged that there are several issues that will require the cooperation of the European Union to execute the MRA; (11) these include issues such as developing a mutually agreed upon inspection report format as well as a joint alert system, joint inspection program, and joint training; and (12) FDA expects to address these issues either through informal discussions with the designated contact points in the European Union and its member states or through formal meetings of the committees established to oversee the implementation of the MRA.

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