Investigator's Workbench


The administration of applications for approval of a new drug is taking more and more time, both for the drug industry as well as the regulatory agencies. On one hand pharmaceutical companies want the submissions to be handled and approved as fast as possible, and on the other the regulatory agencies have to adapt to the rapidly increasing number of submissions. Both parties would thus benefit from a more efficient storage, retrieval and navigation of the material, leading to easier access.

The current review environment was investigated at both the Swedish Medical Products Agency and the Dutch National Institute of Public Health and the Environment. The different attempts in making standards for electronic submissions were tested and discussed. One of these attempts is called MERS, Multi agency Electronic Regulatory Submission Project. MERS is a collaboration between the European authorities and PharmaSoft and uses SGML to structure the information. Using the structure provided by MERS a prototype was made that shows that by marking up information with SGML/XML, it should be possible to develop a more efficient review environment than there exists today.


Get the full report in either PDF or PostScript format.