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The Thai Journal of Pharmaceutical Sciences

Abstract

Background: Drug importation plays a critical role in Thailand’s healthcare system; however, barriers affecting its regulatory control and their public health implications remain inadequately examined. This study compared international drug importation procedures and evaluated Thailand’s control system with strategies for improvement.
Methods: Conducted in Bangkok between 2020 and 2023, this two-phase study employed a qualitative design. Phase 1 involved content analysis comparing drug importation procedures across Thailand, Singapore, Australia and the United States to identify best practices and potential solutions. Phase 2 utilized semistructured, in-depth interviews with 19 key informants from government and private-sector agencies. Data collection was guided by an interview framework informed by the Context, Input, Process, and Product (CIPP) model and Phase 1 findings. Qualitative data were analyzed using thematic analysis.
Results: Phase 1 demonstrated that Singapore and the United States employ advanced technologies and risk-based inspection systems, while Australia applies product-specific risk management frameworks. Phase 2 identified systemic barriers across all CIPP domains. Contextually, outdated legislation and regulatory policy gaps were prominent concerns. Inputrelated deficiencies included insufficient staffing, inadequate standard operating procedures, and limited technological capacity. Process-level barriers encompassed inefficient inspection practices and inappropriate working hours. At the product level, weaknesses in risk management protocols and sampling practices were identified. Proposed strategies included legislative reform, digital technology integration, workforce capacity building, and the adoption of strengthened risk-based regulatory approaches to enhance safety and efficiency.
Conclusions: Thailand’s drug importation control system demonstrates notable weaknesses relative to international counterparts. Modernization through legislative reform, enhanced risk management, and sustained technological investment is essential to ensure drug quality, protect public health, and align Thailand’s regulatory framework with global standards.

DOI

10.56808/3027-7922.3331

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