National fast track procedure promotes early-phase studies in Estonia
The national accelerated assessment procedure used in Estonia is primarily aimed at phase I and integrated phase I/II clinical trials, where Estonia is the only participating Member State. The purpose of this procedure is to:
- promote clinical trials in Estonia,
- support the conduct of innovative and early-phase studies,
- provide sponsors with a fast and predictable assessment process.
The accelerated procedure allows the assessment of the initial application for a clinical trial to be completed within approximately 30–40 days. This gives research institutions and companies the opportunity to start studies faster and makes Estonia a more attractive target country for early-stage development studies.
FAST-EU initiative strengthens European cooperation
In addition to the national procedure, Estonia has also joined the FAST-EU (Facilitating and Accelerating Strategic Trials) pilot project. This is a European-level cooperation initiative with the following objectives:
- to accelerate the coordinated joint assessment of clinical trials involving several Member States,
- to improve cooperation between Member States,
- to collect practical data on the performance and challenges of accelerated assessment,
- to support the development of future regulatory initiatives of the European Union, including in the field of biotechnology.
FAST-EU enables a harmonised and more efficient assessment process for international trials, which helps to bring innovative medicines to patients faster across Europe.
Estonia's contribution to innovation and better patient care
The combination of national and European-level accelerated procedures creates a strong basis for:
- fascilitating the clinical trial environment in Estonia,
- promoting international cooperation,
- supporting research and development,
- improving patients' access to new treatment options.
