Regulatory and Economic Challenges in the Development of Therapeutic Probiotics: A Comprehensive Review

Therapeutic probiotics have gained increasing attention in oncology and immunology due to their potential to modulate host microbiota, enhance immune responses, and alleviate treatment-related toxicities. However, their clinical translation faces significant regulatory and economic barriers. The absence of global standards for probiotic classification, inconsistent quality control protocols, and high costs associated with production and clinical trials hinder their widespread adoption. Moreover, regulatory discrepancies across countries complicate product approval and market access. This review synthesizes current evidence on these challenges and proposes strategic solutions to facilitate the safe and effective integration of probiotics into therapeutic frameworks.

کلیدواژه ها:

Therapeutic probiotics ، Regulatory barriers ، Economic challenges ، Clinical trials ، Global harmonization ، Quality control