Strategic Objectives of Nanotechnology-Driven Repurposing in Radiopharmacy-Implications for Radiopharmaceutical...

Area of Science:

• Nanomedicine
• Radiopharmacy
• Regulatory Science

Background:

• Nanotechnology integration is revolutionizing diagnostic, therapeutic, and theranostic agent development.
• Nanoplatforms enhance radiopharmaceuticals and create multifunctional systems with imaging and therapeutic capabilities.
• Hybrid nanoconstructs repurpose existing compounds, yielding novel pharmacological profiles.

Purpose of the Study:

• To review the challenges in regulating nanomedicines for drug repurposing.
• To examine how nano-biologics and theranostics challenge existing regulatory norms.
• To outline initiatives for harmonized, risk-adapted regulatory frameworks.

Main Methods:

• Review of current literature on nanomedicine in drug repurposing.
• Analysis of regulatory hurdles for complex nanomedicinal products.
• Examination of international efforts in regulatory harmonization.

Main Results:

• Existing regulatory frameworks are inadequate for complex nanomedicinal agents.
• Classification, safety assessment, and preclinical modeling face significant challenges.
• Digital adjuncts like AI-assisted dosimetry introduce new regulatory concerns.

Conclusions:

• Urgent need for updated, harmonized regulatory frameworks for nanomedicines.
• Development of risk-adapted approaches to balance innovation and safety.
• International collaboration is crucial for effective regulatory oversight.