Estonia is the smallest of the three Baltic states in northeastern Europe. When joined the European Union in 2004, Estonia harmonized the clinical trials regulatory processes with the rest of the EU countries.
Medicinal products for human use are regulated by the Medicinal Products Act.
There are 4 general requirements for starting a clinical study:
1) Approval by one of the two independent ethics committees;
2) Informed consent of research subjects in accordance with international codes and the Declaration of Helsinki;
3) Medicinal products for clinical trials must be manufactured in compliance with GMP (Good Manufacturing Practice) and studies must be performed, and data obtained in compliance with GCP (Good Clinical Practice);
4) The notification of the clinical trial must be submitted to the state agency using the EudraCT format.