The provision of good quality, safe and effective medicines and their appropriate use is the responsibility of national governments. The establishment of a national medicine regulatory agency and a designated centre for the study of adverse reactions are central to the achievement of these functions. Multidisciplinary collaboration is of great importance; in particular, links need to be forged between various departments of the ministry of health and also with other stakeholders, such as the pharmaceutical industry, universities, nongovernmental organizations (NGOs) and those professional associations having responsibility for education on rational use of medicines and pharmacotherapy monitoring.
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Box 4 Key elements of pharmacovigilance in national drug policy
• Establishment of national pharmacovigilance systems for the reporting of adverse events, including national and, if appropriate, regional pharmacovigilance centres.
• Development of legislation/regulation for medicine monitoring.
• National policy development (to include costing, budgeting and financing).
• Continuing education of health-care providers on safe and effective pharmacotherapy.
• Provision of up-to-date information on adverse reactions to professionals and consumers.
• Monitoring the impact of pharmacovigilance through process indicators and outcome.
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