Pharmaceutical Research and Manufacturers of America/Food and Drug Administration Cooperation in Building Capabilities f
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PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAD'OOD AND DRUG ADMINISTRATION COOPERATION IN BUILDING CAPABILITIES FOR ELECTRONIC SUBMISSION OF POSTMARKETING SAFETY DATA* WILLIAM S. CALVERT, MPH Director, Information Technology Staff, Food and Drug Administration, Rockville, Maryland
VIRGINIA HOLIHAN,RN, MA Schering-Plough, PhRMA Task Force, Kenilworth, New Jersey
The cooperative efforts of the Food and Drug Administration (FDA)and the pharmuceutical 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. Key Words: Postmarketing; ICH; Electronic submission; Adverse drug reactions; E2b
INTRODUCTION THE DREAM OF GLOBAL electronic exchange of standardized clinical safety data among regulators and the pharmaceutical industry has existed for a long time. The technology for rapid electronic transfer of infor-
Reprint address: Willliam S. Calven, Director, Information Technology Staff, FDNCDEWOPDRAATS, 5600 Fishers Lane HFD-734, Room 15B23, Rockville, MD 20857. *The views expressed in this document are those of the authors, not those of participating individuals, and do not necessarily reflect the views of the Food and Drug Administration, the indicated companies, or the International Conference on Harmonization.
mation is well developed and is used effectively in many industries. Recent ICH agreements have made it possible to consider electronic exchange of standardized data for pharmaceutical products. These global agreements are important not only for rapid exchange of data, but also for improving the capability of regulators and the regulated industry to use these data more effectively. Over the past several years global cornpanies have compressed product development times while studying a greater number of subjects. At the same time, regulatory agencies, including the FDA, have decreased the time required for action on a registration dossier while maintaining high review standards.
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William S. Calvert and Virginia Holihan
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For newly approved products, the first few years on the market usually yield many reports of adverse events as health care providers become familiar with the new products, broader populations of patients are exposed, and prescribing information and other factors are adjusted. As regulators increase their capabilities to rapidly approve new drugs and companies acceler
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