The problem
The lack of affordable, adapted, quality-assured health products for use in low- and middle-income countries delays progress towards global health targets.
Our response
The World Health Organization’s regulation and prequalification program is a cross-cutting intervention that comprehensively addresses shortcomings in manufacture, regulation and supply of priority diagnostics and medicines across multiple diseases or health products. Prequalification creates a large donor-funded market of quality health products, medicines and life-saving vaccines, while ensuring that these are adapted to the realities of low-resourced settings. Prequalification also plays an important role in guiding product innovation and helps to raise manufacturing standards of quality-assured products in low- and middle-income countries.