Preliminary appraisal of clinical drug trials is changing.

Abstract

The EU Clinical Trials Regulation will change the preliminary appraisal of trials and lighten the bureaucracy. Routines of the member states will be standardized, processing of applications provided with tighter time limits, and the licensing procedure made more flexible by using a common European portal. At the same time, definitions will be provided for low intervention trials subject to more flexible rules of follow-up, requirements of master file content, and traceability of test drugs. Implementation of the regulation depends on the completion of the EU portal, currently estimated to take place in the autumn of 2018. Preparations for execution in Finland are carried out by a working group appointed by the Ministry of Social Affairs and Health. On the national level, preparations are in progress to e.g. reorganize ethical evaluation, because the deadlines of evaluation of applications cannot be met with the current structure. Furthermore, regulations concerning insurances and collaterals, language requirements and possibilities of petitioning relating to the applications will also be decided on a national basis.