Overcoming ATIMP Regulatory Barriers: Poland-Belgium Cell Therapy Case Study

Advanced Therapy Medicinal Products (ATMPs, including ATIMPs) in Europe face significant delays and barriers due to national‑level variations in regulation, including organ‑ and tissue‑donation and transplantation laws. This case study shows how ExperTrials’ senior regulatory expertise unlocked a congestive heart failure regenerative therapy trial stuck in cross-border limbo between Poland and Belgium. 

The Challenge: Unexpected Polish Transplantation Law Roadblocks

A Belgium-headquartered biotech sponsor was advancing an innovative autologous cell therapy for chronic advanced ischemic heart failure. The treatment collected patients’ bone marrow stem cells at Polish clinical sites, sent them to Belgium to process them into cardiopoietic cells, and returned them to Poland as ATIMP for heart muscle injection. 

Despite clear CTA pathways, Polish authorities demanded extra approvals under national transplantation legislation for handling and exporting human cells. These went beyond standard EMA clinical trial rules, causing months-long startup delays after a CRO handover. The sponsor needed rapid expertise to interpret laws, secure permits, and set compliant logistics.  

Regulatory Intervention: Targeted Strategy Post-CRO Takeover

A senior regulatory expert from ExperTrials was assigned to stabilize the trial immediately after the study had been taken over from a previous CRO. These are the steps they took to implement regulatory stabilization:  

1. Legal Gap Analysis: A comprehensive analysis of Polish transplantation legislation and its interaction with ATIMP regulations was conducted. The review identified gaps between existing approvals and the additional permissions required under national law.
   
2. Authority Engagement: Our expert prepared and submitted additional documentation, clarifying requirements with the relevant authorities, and securing the approvals necessary to enable cross‑border handling of human cells for manufacturing.
3. Compliant Cross-Border Logistics Setup: Once the regulatory pathway was defined, compliant procedures for the shipment of biological material were established. This included: 

• • Coordinating the collection of patient cells at Polish clinical sites, 
  • Organizing transport to the Belgian manufacturing facility, 
  • Ensuring the safe return of the manufactured ATIMP for administration.

Clear operational responsibilities were defined across clinical sites, the sponsor, and the manufacturing facility to ensure regulatory compliance. Those procedures turned a regulatory deadlock into operational efficiency without compromising patient safety. The trial proceeded fully compliant, accelerating the sponsor’s regenerative therapy pipeline. 

Why Senior Expertise Matters for ATIMP Trials

Advanced therapies like autologous stem cells trigger hybrid regulations—blending EMA ATMP rules with national transplantation/tissue laws. Junior teams often miss these. 

What are the key lessons for biotech sponsors and CROs? 

• • Always audit country-specific laws beyond CTA (e.g., Poland’s Act on Transplantation).
  • Engage senior regulators early for authority relationships and rapid unblocking.
  • Build logistics with EMA GDP compliance for human materials.

ExperTrials can provide senior regulatory expertise to identify legal barriers, engage with authorities, and implement compliant operational solutions—allowing innovative therapies to move forward without compromising compliance or patient safety.