South African Health Products Regulatory Authority acknowledged by WHO

WHO has acknowledged the South African Health Products Regulatory Authority for the vaccine regulatory system which ensures safety, efficacy, and effectiveness. WHO has a global classification system or a ranking standard for national-level regulatory authorities. WHO uses this standard for ranking national authorities for their efforts and active participation in the regulation of medicinal products in their respective countries. This gives an idea of how active the national regulatory authority is in any country. Based on this global classification system, WHO has ranked South Africa’s vaccine regulatory system as the functional level of maturity. This acknowledgment of South Africa’s vaccine regulatory system and the overall South African Health Products Regulatory Authority suggest that the country has a stable, well-functioning, and integrated regulatory system. This suggests that the stable, well-functioning, and the integrated regulatory system ensures the safety, quality, and effectiveness of vaccines in circulation. WHO announced that the country’s vaccine regulatory system now falls on the third level of maturity, which is the second highest level of maturity in the global classification system or a ranking standard for national-level regulatory authorities. While addressing the announcement, Dr. Matshidiso Moeti, WHO Regional Director for Africa, said that the achievement has highlighted the exceptional lead South Africa has taken in healthcare research, ensuring not only the technological lead but also ensuring the safety of people. He added that this achievement is not only special for South Africa but also the whole region as it suggests Africa’s self-sufficiency in vaccines and other healthcare products. The Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, said in his statement that this achievement of South Africa is expected to help the vaccine regulation in the whole region and to create a well-developed and well-regulated mRNA vaccine technology hub in the country and African region. While responding to this announcement by WHO, the Chief Executive Officer of the South African Health Products Regulatory Authority (SAHPRA), Dr. Boitumelo Semete-Makokotlela thanked all the individuals involved in the national regulatory agency and maintaining integrity while performing healthcare product registration. He stated that such efforts have made it possible to offer high-quality, safe, and effective vaccines in the country. He further continued that SAHPRA will continue to keep its integrity in regulating healthcare products in the country, assuring that the medical products circulated in the country are safe and effective and possess higher quality. He also addressed the vision of SAHPRA of being a globally known and acknowledged health regulator and enabler of quality healthcare products. As a part of ranking the national regulatory bodies, WHO uses a global benchmarking tool or the GBT for effectively analyzing the regulatory body on various levels. In 2019, SAHPRA actively contacted the WHO for taking part in the benchmarking tests for getting ranked by WHO. As a part of this, in 2021, SAHPRA  actively developed its operations, thus further refining its benchmarking by GBT with WHO’s aid. Through this analysis, WHO provided an Institutional Development Plan, containing suggestions for SAHPRA, to further improve its operations. Throughout 2022, SAHPRA made many changes to improve its position as a regulator. As a part of this, SAHPRA was acknowledged by offering ML3 ranking for its vaccine regulation.