Introduction
The Estonia State Agency of Medicines has introduced a national accelerated assessment procedure and joined the FAST-EU initiative to support more efficient conduct of clinical drug trials and strengthen Estonia's role in international research and development.
National Accelerated Procedure for Early-Phase Trials
The national accelerated assessment procedure in Estonia is primarily aimed at phase I and integrated phase I/II clinical trials, where Estonia is the only participating Member State.
The procedure aims to:
- Encourage pharmaceutical research in Estonia
- Support innovative and early-stage research
- Provide sponsors with a fast and predictable evaluation process
The assessment of the initial clinical trial application can be completed within approximately 30–40 days. This enables research institutions and companies to start studies faster and enhances Estonia’s attractiveness for early-stage development.
FAST-EU Initiative and European Cooperation
In addition to the national procedure, Estonia has joined the FAST-EU (Facilitating and Accelerating Strategic Trials) pilot project.
The objectives of the initiative are to:
- Accelerate coordinated joint assessment of clinical trials involving multiple Member States
- Improve cooperation between Member States
- Collect practical data on the performance and challenges of accelerated assessment models
- Support future regulatory initiatives of the European Union, including biotechnology
FAST-EU supports a harmonised and more efficient assessment process for international trials, helping bring innovative medicines to patients faster across Europe.
Regulatory pathways supporting accelerated clinical trials require structured preparation and alignment with regulatory expectations across multiple jurisdictions.
Support in regulatory planning and submission processes can be explored here:
https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services
Supporting Research and Patient Access
The combination of national and European accelerated procedures creates a strong basis to:
- Promote the clinical research environment in Estonia
- Increase international cooperation
- Support research and development activities
- Improve patient access to new treatment options
Conclusion
Estonia’s implementation of accelerated assessment procedures, alongside participation in FAST-EU, supports more efficient clinical trial conduct and contributes to strengthening research and development at both national and European levels.
For more information: Accelerated assessment procedures support the conduct of drug trials in Estonia and Europe
