The Study of Information System Development for Post-marketing Control of Health Product in Regional Areas

Abstract

This qualitative research was sim to study the characters of current post–marketing
control system in regional areas and the user requirement of information system in supporting
the post–marketing control system in regional areas. Data was collected between April–August
2013 by interviewing of 30 Food and Drug Administration specialists and focus group discussing
among 60 health product control officers from Food and Drug Administration and Provincial
Health Office. The result showed that the current post–marketing control system was
complicated and also communicated by using the official documents rather than the
information system. Moreover, the current information system was not covered and connected
among central and regional areas. The required information system was to support 6 characters.
Those were the post–marketing product complaint, inspection of Good Manufacturing Practice
(GMP), examination and evaluation of product quality and analytical result, supporting data
linkage through web service, supporting the mobile application, and keeping effective system
security. This study suggested that the pilot study of post–marketing control information
system should be started in some appropriated areas to evaluate the limitation of developed
system for further improvement of this information system according to user requirements.