SNIP Develops French Develop NDA System - Sans Tears

French drug industry association SNIP and the drug agency, the AM, have collaborated to develop what they describe as an economic, low-cost computer-based model for the submission of New Drug Applications to the French regulatory authorities.

The system, designated Sedamm, is less a software program than a method of structuring, presenting and submitting an electronic dossier on CD-Rom, creating a drug industry-drug agency interface. It makes use of widely-available Windows-based information technology, in which the NDA dossier is presented as a hypertext document which is effectively an ".html" file or files of the type in worldwide use on the Internet, using information-accessing browsers such as Netscape and Mosaic. The Sedamm project is intended to tie in with the Mansev projects at European level.