28 Apr SAHPRA and Botswana Medicines Authority partner to enhance medicines regulation in the region
Pretoria, South Africa, 28 April 2024 – The South African Health Products Regulatory Authority (SAHPRA) and the Botswana Medicines Regulatory Authority (BoMRA) have signed a memorandum of understanding (MoU) that will see the two regulators partner on various areas to improve access to new medicines and therapies, the control of falsified and substandard medicines, and the sharing of best practice and regulatory information, amongst others.
The MoU between SAHPRA and BoMRA will allow the regulators to develop a cooperative partnership towards ensuring access to safe, quality, and effective health products in the respective countries.
Areas of cooperation
The partnership paves the way for the two regulators to collaborate and share information on the assessment of medicines and health products, which will result in efficiencies in the medicine approval processes in both South Africa and Botswana. This agreement also enables information sharing on the post-marketing monitoring of medicines for adverse drug reactions, resulting in more robust safety and efficacy monitoring in the interest of the health of the citizens of both countries.
The MoU also formalises joint port of entry operations between SAHPRA and BoMRA aimed at protecting the citizens of both countries from the illegal importation of unregistered, falsified and substandard medicines and health products.
SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, indicates that the partnership is an important milestone in building capacity within the regulators in both countries and ensuring world-class medicines and health products regulation for the benefit of citizens. “This partnership not only ensures robust intra-country post-marketing safety monitoring for health products and the sharing of data that fosters more vigorous assessments of health products; it also ensures that there is best practice sharing and capacity building that ensures that both regulators provide world-class services in their respective countries,” says Dr Semete-Makokotlela.
BoMRA Acting CEO, Dr Seima Dijeng, alluded that the MoU paves the way for a concerted effort towards a shared vision between SAHPRA and BoMRA. According to Dr Dijeng, the MoU signifies not just a partnership but a demonstration of a shared vision for two National Regulatory Authorities. It is a testament to the enduring ties between our two nations, Botswana and South Africa of shared values, mutual respect and economic partnership.