Substantial modifications included in the national pilot of the EU Clinical Trial Regulation
In order to implement the EU regulation on clinical trials, the Finnish Medicines Agency Fimea and the National Committee on Medical Research Ethics (TUKIJA) initiated in November 2020 piloting of the assessment process for new trials. The project has progressed to a stage where, in addition to new protocols, substantial modification applications for clinical trials can also be included in the pilot.
The sponsor may propose the piloting of the substantial modification regardless of whether the original protocol has been included in the pilot. Sponsors are asked to contact TUKIJA before submitting the modification for processing.
Substantial modifications regarding clinical trials are assessed in accordance with the legislation in force. Where applicable, the assessment procedure and processing times detailed in the EU regulation are complied with.
The operating procedure for the pilot can be found on the Fimea website.
Further information and enquiries: