THE Australian Therapeutic Goods Administration (TGA) and the South African Health Products Regulatory Authority (SAHPRA) have signed a Memorandum of Understanding (MoU) to enhance collaboration between the two regulators.
The agreement, signed last week in Pretoria and Canberra, focuses on improving the assessment, approval, and monitoring of various medical products and therapeutic goods.
The MoU aims to strengthen data sharing between SAHPRA and TGA, allowing both regulators to enhance their oversight of medical products, ensuring continued efficacy, safety, and quality.
This includes closer cooperation on safety surveillance and monitoring adverse reactions.
SAHPRA's CEO, Dr Boitumelo Semete-Makokotlela, highlighted that the partnership would expand both regulators' pharmacovigilance programs and enhance their internal expertise.
"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.
"This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance," Dr Semete-Makokotlela said.
Prof Anthony Lawler, Deputy Secretary of the Australian Government Department of Health and Aged Care and head of the TGA, expressed satisfaction with the agreement, and said, "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". JG
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