Estonia

Regulatory

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.

Official links

https://www.ravimiamet.ee/en/clinical-trials-medicinal-products-estonia

Pharmaceutical Industry & Clinical Trials Market

Estonia is one of the smallest pharmaceutical markets in the EU. At the same time, it is a market that is growing at a fast rate.

The country is attractive for Sponsors focused on clinical trials in Oncology. Estonia is among the top 3 countries in the world for kidney and ovarian cancer, and it has one of the highest incidence rates of leukemia and lung cancer in the EU.

First in-human clinical trials are popular in Estonia because of the country’s quick start-up period.

Medical system

Estonia’s medical system has recently been revolutionized by innovative e-solutions. Patients and doctors are benefiting from electronic services.

Every Estonian who visits a doctor possesses an electronic health card, which can be tracked. The information stored on card is confidential. At the same time, it is accessible by authorized persons. The system uses KSI Blockchain technology to ensure data integrity and reduce internal threats to the data.