Pharmaceutical Research and Manufacturers of America/Food and Drug Administration Cooperation in Building Capabilities for Electronic Submission of Postmarketing Safety Data *

Abstract

The cooperative efforts of the Food and Drug Administration (FDA) and the pharmaceutical industry in implementing International Council on Harmonization (ICH) guidelines to establish a practical protocol for electronic transfer of individual case safety reports are described. Nonexpedited safety reports were selected as test material and a multidisciplinary task force guided progress. The issues and problems that were confronted are indicated, along with a summary of how they were overcome. The accomplishments and the unique working style of this task force are highlighted and suggestions are made for future work to consolidate and build upon the success that has been realized.