The Swedish medicines regulatory system — with some notes on the Scandinavian situation
The Swedish Department of Drugs is organized within the National Board of Health and Welfare but acts largely as a separate body.
The Department is financed almost exclusively (> 90%) by fees paid by the pharmaceutical industry.
Priority is given to the programmes ‘Selection of New Drugs’ and the ‘Control of Drugs on the Market’.
During recent years the Department has made special efforts to shorten the processing times of applications for registration (approval) but at the same time the number of incoming applications has gone up.
There are more similarities than differences between the regulatory systems of the Nordic countries. So far, no common registration of drugs has taken place but many other co-operative efforts have been successful.
KeywordsAdverse Drug Reaction Nordic Country External Consultant Licence Application Publicity Activity
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