The Bulgarian Drug Agency has announced reduced time periods for consideration of clinical trials on medicinal products for human use, pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. Both organizations will make efforts for the validation and assessment of the application in the Clinical Trials Information System – CTIS to be carried out within shorter time periods than those provided for in Chapter II of Regulation (EU) No 536/2014. In the event that no inconsistencies are found and no additional information is requested from the sponsor, the evaluation of the clinical trial may be completed within 35 days of the successful validation of the application.
The above approach may apply to mono-national and single-center clinical trials submitted to CTIS that are in later phases, as well as to substantial amendments to the above-mentioned clinical trials.
The change is expected to bring Bulgaria to the forefront of the European Union in the field of clinical trials.