On 26th October 2022, the South African Health Technologies Coalition (SAHTAC), through its Regulatory Harmonisation work, supported the South African Health Products Regulatory Authority (SAHPRA) to host a webinar titled: SAHPRA unpacks global accolade upon receiving WHO Maturity Level 3.
More than 337 people dialed into the webinar which was characterized by many questions and a very engaged audience. A recording of the webinar can be found here: https://path.zoom.us/rec/share/f7vHnEbARJWPyh1E_aw-0K9QDivqhbLw04BoNQIN9-d34dR0ZYNlBBrkJr3GV9fn.5ufMtIT7kMnR9mLk
This webinar followed an announcement made by the World Health Organization (WHO) on 5th October 2022, announcing that SAHPRA had attained WHO Maturity Level 3 (ML3) for vaccine production. This places SAHPRA amongst the first two Africa countries to attain such status for vaccines and amongst the first top 5 National Medicines Regulatory Authorities (NMRA) on the African continent to attain ML3. This also gives SAHPRA the mandate to access internationally recognized medical products for South Africans.
The WHO approval is a significant milestone in South Africa’s health research and vaccines manufacturing ecosystem as SAHPRA will globally be recognized for meeting international standards for vaccine regulations. Regulatory authorities that reach maturity levels 3 and 4 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance1. This positions the regulator as meeting internationally recognized standard and guidelines therefore not only strengthening its level of authority but contributing to the growth of the African manufacturing industry. Additionally, this positions SAHPRA favorably as a technical agency that can support the newly formed African Medicines Agency (AMA).
Background
WHO uses a global classification system to rank NMRAs on their level of functionality and maturity. This bench marking process is based on a set of standardized indicators that assess various measures including market surveillance, laboratory testing, regulatory inspection, and marketing authorization to name a few. A team of global experts perform an audit towards the determination of the ranking. Through this process, an NMRA is found to either rank ML1 where minimal regulatory systems exist to ML4 which is the highest ranking showing advanced level of performance.
Stemming from several gaps that were identified in a 2021 WHO audit, SAHPRA embarked on a mission to implement its Institutional Development Plan (IPD). Implementation of this plan culminated in achieving SAHPRA’s current milestone.
To this end, SAHPRA in partnership with SAHTAC has organized a webinar to create an opportunity to illuminate what this accolade means for the regulator, to ordinary South Africans, to the medical products industry and to the continent’s manufacturing plans. The webinar will also give insights into SAHPRA plans for reaching ML4.
