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New EU regulation for clinical trials


The European Council has decided upon a new regulation for clinical trials and in Sweden, the Medical Products Agency together with the six regional ethical review boards, missioned by the government, have made a proposal for a common collaboration structure.

Today, according to the operative legislations, the sponsor, the one that applies for permission for a clinical medicine trial, receives separate decisions from the Medical Products Agency and the Ethical Review Board. In short, the new regulations means that the sponsor sends in its application in a common EU portal and in each country only one decision per application is made.

“This means increased clarity regarding the clinical trial decisions,” says Gunilla Andrew-Nielsen at the Medical Products Agency. “There will also be higher claims that the application is complete in order for us to process it and we will focus on directed information to the applicant sponsors.”

The investigation “A new organization for ethical review and research” was recently sent to referral and the Medical Products Agency supports the investigation’s proposal that all ethical review is gathered under one authority and that it is a prerequisite for an effective administration of clinical trials.

In order to test and evaluate the proposed collaboration structure, the Medical Products Agency has initiated a pilot project with, at the moment, two trials.