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WAHO Guideline on Regional Post Market Surveillance Guidelines for Medicines and Medical Devices
Author:
WAHO
Category:
Clinical Trials, Pharmacovigilance and Medicines Safety
Language:
English
Description
The purpose of this guideline is to strengthen systems for effective Post Marketing Surveillance of medicines, and regulated products including medical devices to ensure that only quality and safe medicines and other regulated products are distributed throughout the West African sub-region. Effective implementation of PMS Guidelines will enable NMRAs generate scientific evidence on the quality and safety of medicines and medical devices for improved health outcome. It is important that WAHO sustains a high quality and scientifically credible safety and efficacy data on these vital health commodities to enhance evidence based decision making that impacts public health.
Abstract
The purpose of this guideline is to strengthen systems for effective Post Marketing Surveillance of medicines, and regulated products including medical devices to ensure that only quality and safe medicines and other regulated products are distributed throughout the West African sub-region. Effective implementation of PMS Guidelines will enable NMRAs generate scientific evidence on the quality and safety of medicines and medical devices for improved health outcome. It is important that WAHO sustains a high quality and scientifically credible safety and efficacy data on these vital health commodities to enhance evidence based decision making that impacts public health. 1.2 Scope: The PMS plan is designed to cover a wide range of medicines and regulated products marketed in West African sub-region in order to strengthen and improve their quality and safety. Ensuring that there is adequate funding is vital during the PMS planning. In a situation where resources are limited, the PMS program can focus on medicines and parameters that pose higher risk to patients by applying risk analysis during the planning phase. Collaboration with relevant partners and sharing of resources including testing capacities, experiences and information can enhance the effectiveness of PMS program.
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