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Pharmacovigilance system in Saudi Arabia.

Saudi Pharm J · 2017 · PMC5357102 · PMID 28344483

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an increasing trendno p-value reported
However, reports from Marketing Authorization Holders (MAHs) show an increasing trend. 73,067 reports (95%) were received from drug companies, 2856 reports (3.71%) were received from hospitals and only 131 (0.17%) reports were received from the general public ( Saeed, 2014 ). 3.1.4 Periodic Safety Update Reporting (PSUR) and pharmacovigilance actions The periodic safety update reporting (PSUR) was started in the early 1990s by the Council for International Organizations of Medical Sciences (CIOMS) and was widely accepted and implemented in many parts of the world including the Kingdom of Saudi Arabia ( Klepper, 2004 ).

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