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Health Minister Aaron Motsoaledi has appointed members of the South African Health Products Regulatory Authority (SAHPRA) board‚ which replaces the Medicines Control Council (MCC).
The MCC was beset by backlogs‚ taking much longer compared with US or European regulators to approve new medicines and clinical trials.
The scope of the new authority has expanded to include medicines‚ medical devices including in vitro diagnostics‚ and aspects of radiation control. Until now‚ medical devices and complementary medicines had gone unregulated as the MCC could only deal with medicines‚ BusinessLIVE reported last year.
The National Department of Health said SAHPRA would operate as a separate juristic entity‚ responsible for monitoring‚ evaluation‚ regulation‚ investigation‚ inspection‚ registration and control of medicines‚ scheduled substances‚ clinical trials‚ medical devices and related matters in the public interest.
The department said there was a plan to speed up the processes.
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