The future of clinical research in Poland requires joint action – event summary

On June 16, 2025, we had an opportunity to took part in the strategic meeting “Building a Bright Future for Polish Clinical Research. We Can Do It Together!”, held in Warsaw. The event brought together nearly 60 key stakeholders from the clinical trials ecosystem, including representatives of the Office for Registration of Medicinal Products (URPL), the Supreme Bioethics Committee, and leading organizations such as GCPpl, POLCRO, and INFARMA, as well as national and international experts.

Chaired by Dr. Ingrid Klingmann, the discussions focused on actionable improvements to the regulatory landscape in Poland, drawing on proven strategies from across Europe and beyond. This working meeting aimed to initiate a coordinated effort and draft joint recommendations that will help Poland maintain and strengthen its position in the global clinical research environment.

We would like to thank the organizers and panelists for creating a space for open, solution-focused dialogue between decision-makers, experts, and industry stakeholders.

We strongly believe that only through collaboration and coordinated effort can we meaningfully shape the future of clinical research in Poland and improve its position on global market.

Key topics discussed:

• How to remain competitive – insights from the report “Industry Clinical Trials in Poland – Progress Review Through 2024”

• European countries’ strategies to increase their attractivity for clinical trials

• The Netherlands as a case study – dedicated early-phase ethics committee and accelerated regulatory review

• Legal perspective – possibilities within the current Clinical Trials Regulation (CTR) framework

What must change for Poland to stay competitive in global clinical research?

• Reduce approval timelines – currently around 90+ days, which significantly deters sponsors and
  

• Lower tax burdens for CROs and sponsors – although standard CIT is 19 %, additional administrative and compliance costs reduce Poland’s competitiveness compared to other EU countries

• Build a comprehensive sponsor support infrastructure, improve Polish Clinical Trials landscape.– from CRO selection and legal/admin guidance to study close-out.