Since end users and healthcare workers cannot reliably judge product quality, regulatory authorities are essential to ensure safety, quality, and efficacy across the full product lifecycle.
Effective regulatory systems support public health outcomes, innovation, and investment, while weak systems delay access to safe and quality medicines.
The WHO Global Benchmarking Tool (#GBT) is used to assess regulatory systems, identify gaps, and guide improvement plans. Since 1997, over 150 countries have been benchmarked.
The GBT also incorporates the concept of ‘maturity level’ or #ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 (existence
of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement).
𝐆𝐁𝐓 𝐜𝐨𝐯𝐞𝐫𝐬 𝟗 𝐤𝐞𝐲 𝐟𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐬:
• National Regulatory System (RS)
• Marketing Authorization (MA)
• Vigilance (VI)
• Market Surveillance (MC)
• Licensing (LI)
• Inspection (RI)
• Laboratory Testing (LT)
• Clinical Trials Oversight (CT)
• Lot Release (LR)
In Africa, countries that have reached #ML3 according to March edition include:
#Egypt Egyptian Drug Authority (#EDA)
#Ethiopia (Ethiopian Food and Drug Authority (EFDA)
#Ghana Food and Drugs Authority,Ghana
#Nigeria (National Agency for Food and Drug Administration and Control (NAFDAC))
#Rwanda Rwanda Food and Drugs Authority
#Sénégal Agence sénégalaise de Réglementation Pharmaceutique
#SouthAfrica South African Health Products Regulatory Authority (#SAHPRA)
United Republic of #Tanzania Tanzania Medicine and Medical Devices Authority (TMDA)
#Zimbabwe Medicines Control Authority of Zimbabwe (#MCAZ)
𝐍𝐨𝐭𝐞
I need to highlight that track and trace can indirectly help in increase many points in the #GBT, how ever it is clearly mentioned in point 𝐌𝐂𝟎𝟏.𝟎𝟓 in 𝐦𝐚𝐫𝐤𝐞𝐭 𝐜𝐨𝐧𝐭𝐫𝐨𝐥 𝐚𝐧𝐝 𝐬𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 𝐆𝐁𝐓 which mentioned "Legal provisions and regulations exist for placement of a product’s unique identification number on its outer packaging."
𝐃𝐞𝐬𝐜𝐫𝐢𝐩𝐭𝐢𝐨𝐧: The assessor should verify the availability of legal provisions and regulations setting the rules for placement of a unique identification number on the outer package of each medical product. Legal provisions and regulations should indicate that an identification number is assigned to each product that receives marketing authorization.
𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭: Legal provisions, regulation and guidelines for the placement of product’s unique identification number on outer packaging.