The Bulgarian Drug Law amendments published on 12-Oct-2018 introduced the biggest changes in the field of clinical trials in many years. Apart from synchronizing with Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, the national law amendments also completely restructure the national system of ethics committees.
The ethics committees in Bulgaria used to be organised on three levels:
1. Central Ethics Committee (CEC) that carried out methodical and arbitrational functions related to the other ethics committees.
2. Ethics Committee for Multi-Centre Clinical Trials (often referred to as KEMI).
3. Local Ethics Committees (LEC) established at hospital level.
The Drug Law amendments completely replace the existing ethics committees. There will be no LECs at hospital level. They are replaced by a “contact person” appointed at each centre who will have monitoring functions and will partially take over the functions of the former LECs. CEC and KEMI will also cease their existence. Instead, there will be a single Ethics Committee on Clinical Trials*.
The legislation changes aimed at reducing the administrative burden. The changes need to be considered by clinical trials sponsors in relation to the initiation procedure and safety reporting in case of centres located in Bulgaria. The amendments also allow conducting clinical trials in dialysis centres and in individual and group practices for primary and specialized medical care.
*Update February 2019: the new Ethics Committee on Clinical Trials was established by an Order of the Minister of Health (Заповед № РД-02-16/31.01.2019) and it replaced KEMI. LECs will continue to operate in some of the centres until the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable.