Lithuania is the largest of the three Baltic States. As many other European countries, after joining the European union in 2004, Lithuania has harmonized legislation on clinical trials with the EU standards.
Clinical trials in Lithuania are regulated by the State Agency for Drug Control. There are also 2 ethical bodies:
- Ethical reviews of clinical trials are carried out by Central Ethics Committees (CEC)
- Lithuanian Bioethics Committee (LBEC) is the main institution responsible for ethical evaluation of clinical trials in Lithuania.
These regional committees are authorized to consider applications for clinical trials that are planned only at research sites within the scope of the committees.
On average, it takes about 60 days to obtain all necessary approvals – the timelines are relatively short because all applications can be submitted in parallel.