Guideline Detail

Reporting Adverse Drug Reactions in South Africa

Source: South Africa National Department of Health
Publication Date: December 1, 2012

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2012 guidance from the South Africa National Department of Health and the Medicines Control Council intended to assist applicants in the reporting of adverse drug reactions associated with medicines and in the management of safety data, which arise during clinical trials. Topics addressed include: procedures for reporting; postregistration adverse effect reports; and preregistration adverse event reports.

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Keywords: HIV - Adverse Events, HIV - Resource-Limited Settings