Aggregate Analysis of the Export Petition and Waiver Process: A Pharmaceutical Industry Perspective

Abstract

In an effort to harmonize the introduction of drugs onto the global market, many United States pharmaceutical companies have focused on the globalization of their drug development process and have, therefore, increased the number of clinical registration studies conducted outside of the United States. A key Food and Drug Administration requirement that must be addressed to support the conduct of these trials outside of the United States is that of the export waiver. To ascertain the efficiency of the current export petition and waiver process, export data from 1998 to 2001 were evaluated. The primary metrics included mean time to approval (days), range of approval days, number of export waiver requests, and export receiving countries. Linear regression was used to calculate the rate of approval time change and identify the qualitative trend with respect to this change. Using this approach, the rate of increase in approval time for export waivers was determined to be eight days per year. Therefore, over the past few years, there has been a steady increase in the number of days required to receive export waivers from the Food and Drug Administration.

Keywords

Export petition and waiver Clinical studies Process improvement Metrics Aggregation

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References

US Food and Drug Administration. Draft FDA Guidance for Industry on: Exports and Imports under the FDA Export Reform and Enhancement Act of 1996. Rockville, MD: US Food and Drug Administration; February 1998. www.fda.gov/opacom/fedregister/frexport.html.

21 CFR § 312.110(b).