

MSF witnesses the issue of substandard medical products in countries where we work. While improved data on the prevalence of the problem are needed, its root cause is well-known: regulatory systems in producing and importing countries.
Key manufacturing countries, particularly low- and middle-income countries (LMICs), should actively participate in the WHO regulatory systems strengthening programme to establish their maturity level (ML) for both medicines and vaccines, working towards becoming WHO-listed authorities (WLAs).
Importing countries can rely on WHO Prequalification (PQ). For medical products outside the PQ scope, ML1/2 countries should consider relying on authorities transitioning towards becoming WLAs.
The link between Member State Mechanism (MSM), WHO Global Surveillance and Monitoring System (GSMS), Regulatory Systems Strengthening (RSS) / Global Benchmarking Tool (GBT) and PQ is unclear; they should be integrated to best ensure a significant decrease in the circulation of substandard medical products.