committee uses the term informatics strategies to describe how the data are cleaned of errors, transformed to proper formats, analyzed, and shared promptly with regulatory agents for better decision making.

Modern information management uses networked computing infrastructure across national borders. Information management lays the foundation for computer-assisted automated information extraction. Without such data, risk modeling would be impossible. The strategy outlined in this report also emphasizes the need to share information across international borders. The committee feels that the FDA should promote the development of secure and open protocols for electronic data capture, computerized data management, electronic data sharing, and decentralized data exchange. It is suitable that the FDA provide leadership in this international endeavor.

A good architecture for storing, collecting, and exchanging information is key to reliable, modern food and medical product regulation, although the importance of such a system, especially in developing countries, is not always obvious. A regulatory agency has to access data and information about drug registration, facility inspections, and surveillance from disparate data sources and in varying formats on an ongoing basis. In developing countries much of these data is still stored as paper documents. This severely decreases the productivity of the already thinly staffed regulatory agencies. A functional informatics system thus has the ability to enhance the productivity of regulatory agencies in developing countries. Well-defined data architectures and topologies can allow the multiple agencies regulating food and medical products to coordinate their work and reduce redundancy. In addition to sharing across different agencies within a country, common data architectures and good systems for information sharing can also facilitate better international harmonization. For example, the use of a reliable information system can allow the FDA to share inspection reports with its counterpart agencies in developing countries and vice versa.

Collecting data in common formats can also lay the groundwork for developing tools that will make regulatory agencies more productive. Pharmacovigilance and postmarket surveillance are two areas that could greatly improve with informatics tools that allow for simpler data collection and analysis. The path to having modern informatics tools in developing country regulatory agencies depends on the FDA leading in defining common standards, which will enable data collection, sharing, and (at some time in the more distant future) advanced decision support. The committee believes that moderate investments in informatics and information technology will yield significant long-term benefits in the quality of food and drug regulation.



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