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This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.
Post-Marketing Reporting of Adverse Drug Reactions to Human Medicinal Products in South Africa (MCC: 2.33, Sept 2016)
The document assist the reporting of adverse drug reactions (ADRs) and in the management of safety data during post-registration and post-marketing clinical trials. To confirm that you have the latest version of this document, please visit: http://www.mccza.com
Recommendations for an application for a licence to manufacture, import or export medicines and medical devices. GWP guidelines apply.