Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products

In early 2025, ISoP approved the formation of a Special Interest Group (SIG) dedicated to Advanced Therapy Medicinal Products (ATMP) and Radiopharmaceuticals (RP). This SIG provides a focused pharmacovigilance (PV) forum to address the unique complexities and regulatory considerations associated with these innovative modalities.

Even though Advanced Therapy Medicinal Products (including cell and gene therapies (CGTs)) and radiopharmaceuticals are different modalities, they both pose distinct pharmacovigilance challenges. As global regulatory frameworks continue to evolve and vary by region, the need for specialized, coordinated approaches becomes increasingly urgent and important.

• ATMPs involve cutting-edge treatment approaches that require long-term safety monitoring and advanced tracking methods. Their development and commercialization are accelerating globally.
• Radiopharmaceuticals, which use radioactive compounds for diagnosis or therapy, present their own PV challenges, often requiring customized regulatory pathways and careful benefit-risk assessments.

Key Pharmacovigilance Considerations include:

For ATMPs:

• Long-term follow-up (up to 15 years post-treatment)
• Differentiated causality assessments
• Bidirectional traceability (from raw materials to patient and vice versa)
• Safety’s role in Environmental Risk Assessments (ERAs) for gene-modified organisms (GMOs)
• ATMP-specific safety reporting obligations
• Adapted signal and risk management approaches

For RPs:

• Coordination across multiple regulatory frameworks
• Need for tailored PV systems and procedures

This is a call to all ISoP members: If you are interested in advancing the field of pharmacovigilance
for ATMPs and/or RPs, we invite you to join the SIG.

Would you like to join or learn more about this group? Contact us at administration@isoponline.org