What's Happening?
The World Health Organization (WHO) has been operating its Prequalification Programme (PQP) since 1987, aimed at ensuring that health products meet global standards of quality, safety, efficacy, and performance. This initiative is crucial for low- and middle-income
countries (LMICs) where regulatory systems are often inadequate. The PQP covers a wide range of health products, including medicines, vaccines, medical devices, and vector control products. By prequalifying these products, WHO provides a trusted benchmark for international procurement agencies, governments, and other stakeholders, ensuring that the health products they purchase are safe and effective. The programme has expanded over the years to include new product streams and has been instrumental in improving global public health by facilitating access to quality-assured health products.
Why It's Important?
The WHO's Prequalification Programme plays a vital role in global health by ensuring that billions of dollars' worth of health products procured annually meet stringent quality standards. This is particularly important for LMICs, where access to safe and effective health products can be limited. The programme not only helps in the procurement of quality products but also drives competition among manufacturers, leading to price reductions and improved health outcomes. By raising manufacturing standards, the PQP has enabled many LMIC-based manufacturers to achieve prequalification, thus enhancing local production capabilities. The programme's impact extends beyond donor markets, influencing national procurement decisions and contributing to universal health coverage and global health security.
What's Next?
The WHO plans to continue expanding the scope of its Prequalification Programme to include a broader range of essential health products, reflecting evolving epidemiological needs. This includes promoting regulatory reliance mechanisms to speed up product approvals globally and aligning prequalification processes with WHO technical programme priorities. The organization is also committed to strengthening collaboration with national regulatory authorities to enhance their capacity for product evaluation and oversight. These efforts aim to ensure timely access to quality-assured products and address inequities in countries that rely on WHO recommendations for the use of these products.
Beyond the Headlines
The WHO's Prequalification Programme not only ensures product quality but also guides innovation and early-stage development of health products. It has been pivotal in bringing new treatments to market, such as paediatric tuberculosis treatments and HIV self-tests. The programme also supports the development of global norms and standards, contributing to the harmonization of regulatory practices across countries. By fostering a global environment where quality health products are the norm, the PQP helps optimize health resources and improve health outcomes, particularly in resource-limited settings.
