EVERYTHING
According to Who, a significant portion of the global population remains vulnerable to substandard or falsified medical supplies due to inadequate regulatory oversight. Currently, 70% of countries lack the robust systems necessary to effectively monitor medicines and vaccines. This systemic weakness creates a high risk for patients in resource-limited settings who rely on international procurement agencies for life-saving treatments.
Expanding the scope of global health standards
To mitigate these risks, the WHO established the Prequalification Programme (PQP) as a trusted benchmark for safety, efficacy, and performance. While the WHO is not a formal regulatory authority, its prequalification serves as a gold standard that allows United Nations agencies, nongovernmental organizations, and member states to make informed purchasing decisions. By vetting products before they enter the international market, the program ensures that billions of dollars in health spending reach their intended targets without compromising patient safety.
The initiative originally launched in 1987 specifically to support UNICEF’s vaccine procurement efforts. Since its inception, it has grown significantly, and as of the end of 2025, more than 1,700 health products are listed under the program. The scope now encompasses a diverse range of essential items beyond basic vaccines, including:
- Medicines and vaccines for routine immunization against 24 priority diseases
- Immunization devices and cold chain equipment to maintain temperature integrity
- In vitro diagnostics and other specialized medical devices
- Vector control products used in malaria and other disease prevention
- Snake antivenoms evaluated for efficacy and manufacturing quality
Rigorous assessment and registration mechanisms
The PQP utilizes a transparent, scientifically sound assessment process tailored to each specific product stream. Depending on the item type, this evaluation may involve comprehensive dossier reviews, rigorous product testing, labeling audits, and physical inspections of manufacturing sites or quality control laboratories. These measures are designed to provide a reliable safety net for humanitarian crisis settings where rapid deployment is often required.
Furthermore, the program facilitates faster access to these products through the WHO Collaborative Registration Procedure. This mechanism allows countries to accelerate the registration of prequalified medical products by relying on the WHO's existing evaluations. By streamlining these administrative hurdles, the PQP ensures that quality-assured health products reach low- and middle-income countries more efficiently, ultimately protecting global public health from the dangers of unregulated medicine.