TGA, South African regulators sign MoU

2 minute read


The agreement will see the two nations share knowledge and experiences regarding regulatory data and processes.


The Australian Therapeutic Goods Administration and the South African Health Products Regulatory Authority have signed a memorandum of understanding that will improve the capabilities of both health product regulators.

The MoU is the latest step in an existing relationship built on a mutual desire to improve how medical devices and therapeutics are assessed and monitored for safety and efficacy throughout the application process.

The two organisations will share data in an attempt to make both regulators operate more effectively.

Professor Anthony Lawler, head of the TGA and Deputy Secretary at the Department of Health, said he was pleased to see the two nations strengthen their collaborative agreement.

“We look forward to working alongside our regulatory counterparts in South Africa to share important regulatory information to ensure the continued safety, quality and efficacy of therapeutic products approved for market,” Professor Lawler said in a statement.

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SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the agreement would be of particular benefit to the regulators’ pharmacovigilance monitoring programs.

“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use,” said Dr Semete-Makokotlela.

“This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality.”

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