More efficient decision-making path for medicine studies
In conjunction with the Council of Europe deciding on a new directive for clinical therapy studies using medicines, the Swedish Medical Products Agency and the regional ethical review boards were tasked by the Government to present a joint collaboration structure that also included biobanks and radiation protection committees.
In the regulations that currently apply, an applicant for authorisation for a clinical therapy study using medicines receives separate decisions from the Medical Products Agency and the ethical review board. Briefly, the new EU directive means that the application will be sent in to a joint EU portal and that each country then only makes one decision per application.
The report “En ny organisation for etikprövning och forskning” (“A new organisation for ethical review and research”) proposes that all ethical review shall be gathered together under one public authority, and the Medical Products Agency has started a pilot study to evaluate the proposed collaboration structure.