The World Health Organization Prequalification Program and Clinical Pharmacology in 2030 (Journal article)

The document discusses the World Health Organization Prequalification Program (WHOPQ) and its relationship with Clinical Pharmacology. The WHOPQ has been instrumental for over 23 years in providing a rigorous assessment of the quality of medicines, vaccines, and medical devices, especially for resource-limited settings. Established with support from multiple international organizations, the WHOPQ program began for vaccines in 1996 and for medicines in 2001. It later expanded to include in vitro diagnostics (IVDs) and vector control products. The program's primary objective was to assist United Nations procurement agencies in identifying manufacturers that met international standards of quality, safety, and efficacy.

However, as the number of essential products has increased, the resources of the WHOPQ program are being stretched. There's a call for the program to expand its scope to include new classes of medicines, such as biologics, and other essential medicines. Clinical pharmacology, with its advances, can play a pivotal role in addressing these challenges. Techniques like computational modeling can improve generic drug availability by reducing development time and costs. Furthermore, the document emphasizes the need for trained clinical pharmacologists with a diverse skill set to achieve the goals set for 2030. The challenges ahead are significant, but with the integration of clinical pharmacology, there's potential to ensure access to quality-assured health care products in low- and middle-income countries.