Germany

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.bfarm.de
https://www.pei.de

Pharmaceutical Industry & Clinical Trials Market

Germany is one of the world’s leading locations for clinical trials. The country is a leader of R&D investment and patent application levels. Combining cutting edge-innovation, a long tradition of being the “world´s pharmacy” and a continuously growing demand for healthcare products, Germany constitutes the major European pharmaceutical market and the fourth largest worldwide. Over 30 biotechnology clusters contribute to the pharmaceutical innovation.

Medical System in Germany

The German healthcare is a dual public-private system. The sector is regulated by the Joint Federal Committee Healthcare ensuring free healthcare for all. In addition, it is possible obtain private health insurance to replace or top up state cover.

Germany spends 11.1% of annual GDP on healthcare expenditure.