Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Topics

UsernamePublicRestriction

Register

SC031101

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel