Health products authority board appointed

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 to 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.

It would be 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.

There was a plan to speed up the processes‚ the department said.

“The authority will utilise external experts for evaluation of applications‚ but over time it will actively grow the in-house capacity of the staff to take over the bulk of its work.

“In addition‚ agreements will be made for recognition of work from recognised international regulatory authorities‚ resulting in more rapid evaluation timelines.”

Portia Nkambule‚ previously a director in the MCC‚ has been appointed as acting SAHPRA chief executive. The chief executive will be appointed by the board in consultation with the minister.

Professor Helen Rees is the SAHPRA board chairwoman. She was chairwoman of the MCC.