Approval processing and capacity

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Obtaining approval to conduct a clinical trial in Medicon Valley is quite straightforward. A sponsor/investigator writes a clinical protocol and the application form is submitted to the authorities.

In both Denmark and Sweden a pharmaceutical company may conduct multi-center trials in multiple regions of the country following a single submission to the ethics council in the region where the principal investigator is located. Approval from this council will be automatically accepted in all other centres. The ethics councils meet once a month and the average review time is five to six weeks.

The applications to the national medical agency and the council of ethics can take place simultaneously. Subsequently, the ethics committee will forward its opinion directly to the national regulatory body.

The entire process with approval from both institutions usually requires only six to eight weeks, after which the clinical trial can take from 2-45 months, according to a Boston Consulting Group study.