Austria

Regulatory

Under Regulation (EU) No 536/2014, clinical trials in the EU are authorized through the Clinical Trials Information System (CTIS). A sponsor submits one harmonized application via the EU-portal for all intended Member States. The dossier is split into:

• Part I (scientific and technical documentation, common to all CMS)
• Part II (national documents, including ethics requirements)

One Reporting Member State (RMS) coordinates the scientific review, which must be completed within 45 days, with parallel national (Part II) reviews. Requests for information may pause the clock. Each Member State must then issue a decision within 5 days, leading to an overall maximum of 60 days (extensions possible for complex therapies).

The CTR harmonizes approvals across the EU, integrates ethics committees into the process, and ensures transparency through the EU trial database. Since 31 January 2023, all new trials in the EU must follow this system.

Official links

https://www.basv.gv.at

Pharmaceutical Industry & Clinical Trials Market

Austria is one of Europe’s most dynamic pharmaceutical markets, combining cutting-edge research, high-quality manufacturing, and a strong regulatory framework. With a thriving life sciences sector and a proven track record in clinical trials, Austria stands out as a gateway for innovation and healthcare advancement. Austria’s pharmaceutical and life sciences industry is a key pillar of its economy.
There are ~120 pharmaceutical manufacturers and importers and ~100 enterprises dedicated to producing pharmaceutical preparations. Over 60,000 employees in Austria are working for life sciences and generating more than €25 billion in revenue (or about 7% of GDP). The Austrian pharmaceutical market continues to grow steadily ~€3.4 billion (2024) projected to reach €4.8 billion by 2030 (CAGR ~4.6%). Key growth areas are oncology, biologics, and generics.
Austria’s regulatory environment ensures quality, transparency, patient safety and is fully aligned with the EU Clinical Trials Regulation (CTR) since 2022. National oversight by BASG, the Austrian Medicines Agency.

Medical System in Austria

Austria operates a universal, publicly funded healthcare system. The system is largely financed through mandatory health insurance contributions and supplemented by government funding and private payments.
Social Health Insurance (SHI) is compulsory for employees and the self-employed, covering about 99% of the population. Austria has a dense hospital network, including public, private non-profit, and private for-profit hospitals. Around 65% of hospital beds are in public hospitals, funded and managed by federal states. University hospitals in Vienna, Graz, and Innsbruck also serve as research and clinical trial hubs.
There is a high level of public trust in the healthcare system, which supports patient participation in clinical trials. Strong collaboration between public hospitals, universities, and industry ensures rapid trial recruitment.
Austria’s centralized insurance and healthcare structure makes data collection and monitoring efficient for research and health outcomes.