Regulatory Compliance and Supplier Risk Assessment Frameworks in International Pharmaceutical Procurement

International pharmaceutical procurement has emerged as one of the most scrutinized domains of global trade, largely due to the complex interplay between regulatory compliance requirements, supplier performance, and risk management. As supply chains have become increasingly globalized, ensuring the integrity, safety, and reliability of pharmaceutical products has grown into a critical challenge for regulators, procurement bodies, and manufacturers. Supplier-related risksranging from quality failures and counterfeiting to non-compliance with Good Manufacturing Practices (GMP)can jeopardize public health, regulatory credibility, and corporate reputations. Accordingly, frameworks that systematically integrate regulatory compliance and supplier risk assessment have become indispensable for ensuring procurement decisions that safeguard patients, optimize costs, and promote supply chain resilience. This paper provides a comprehensive literature-based review of frameworks and methodologies developed up to 2022, with a particular focus on how international regulatory standards, supplier evaluation models, and risk assessment tools converge in the pharmaceutical sector. The study examines historical developments, methodological approaches, and the increasing role of data-driven risk assessment and compliance monitoring in pharmaceutical procurement. By synthesizing prior research, this paper highlights methodological strengths, gaps, and the need for holistic frameworks that capture regulatory, operational, and ethical considerations. The findings underscore the strategic role of compliance and risk assessment in enabling transparent, resilient, and sustainable pharmaceutical procurement systems across international contexts.