Strengthening pharmacovigilance systems is a more complex undertaking than capacity building for most other regulatory functions defined by the WHO global benchmarking tool. International collaboration between National Regulatory Authorities and coordination with other technical assistance providers is essential for building a sustainable pharmacovigilance system in resource constrained settings. Implementing practical initiatives that track a long-term strategy should be favoured over attempts to mirror the systems of high income countries. Forging strong linkages between public health programmes, hospitals and national pharmacovigilance centres is critical. A systemic focus on detecting medicine quality issues, augmented by greater engagement in international forums like the WHO Member State Mechanism on Substandard and Falsified Medical Products will aid efforts to secure medicine and vaccine quality and safety in the Indo-Pacific region.

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Pragmatic Pharmacovigilance and Combatting Substandard and Falsified Medical Products (SFs)

  • Paul B. Huleatt

摘要

Strengthening pharmacovigilance systems is a more complex undertaking than capacity building for most other regulatory functions defined by the WHO global benchmarking tool. International collaboration between National Regulatory Authorities and coordination with other technical assistance providers is essential for building a sustainable pharmacovigilance system in resource constrained settings. Implementing practical initiatives that track a long-term strategy should be favoured over attempts to mirror the systems of high income countries. Forging strong linkages between public health programmes, hospitals and national pharmacovigilance centres is critical. A systemic focus on detecting medicine quality issues, augmented by greater engagement in international forums like the WHO Member State Mechanism on Substandard and Falsified Medical Products will aid efforts to secure medicine and vaccine quality and safety in the Indo-Pacific region.