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Swiss task force to tackle regulatory delays

This article was originally published in Scrip

Executive Summary

Swissmedic, the medicines regulator, plans to hire 20 to 25 specialists for a task force that will tackle a backlog of regulatory work. Around 1,100 initial marketing applications for innovative products, non-innovative products (mainly generics and parallel imports), variations and periodic safety update reports have not been handled within agreed timelines, the agency says. It adds that the current situation is unsatisfactory and that the task force will target its efforts on the most urgent dossiers. Existing agency staff will begin putting the task force in place in early August with a view to recruiting new employees by the end of the year. Swissmedic is aiming to have eliminated the regulatory backlog by the end of 2010. Current marketing applications that are still being processed within statutory timeframes will continue to be handled in the usual way. The task force will report to the agency's director general.





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