This momentum is largely driven by the ambition to achieve WHO Maturity Level 4 (ML4), which reflects a high-performing, well-functioning regulatory system.
A key requirement within the World Health Organization Global Benchmarking Tool (GBT) framework is the establishment of robust legal provisions mandating the placement of a product’s unique identification number on its outer packaging. This requirement sits at the core of market surveillance and regulatory control, both of which are critical assessment pillars for achieving ML4 status.
Serialization serves as the foundational enabler of this capability. By assigning unique identifiers to pharmaceutical products, regulators gain the ability to verify authenticity, monitor product movement, and strengthen oversight across the supply chain.
However, the impact of track-and-trace extends beyond serialization alone.Its implementation significantly enhances multiple GBT indicators,particularly in post-market surveillance, risk-based inspections, and the efficiency and precision of product recall mechanisms.
Countries that deploy end-to-end traceability systems are better positioned to detect substandard or falsified products, respond rapidly to incidents, and ensure patient safety at scale.
In essence, track-and-trace is no longer a technical upgrade,it is a strategic regulatory capability directly linked to achieving and sustaining WHO ML4.