About us

Making sure people can access safe, effective, and good‑quality health products is essential for public health worldwide. Yet many countries do not have strong regulatory systems in place. As a result, people may struggle to get the medicines and health products they need, or they may be exposed to poor-quality or falsified products.

For many years, WHO has worked closely with countries to strengthen their national and regional regulatory systems, including helping them prepare for public health emergencies. We do this in partnership with WHO regional and country offices, with the goal of supporting regulation that works well and supports strong health systems. Good regulatory oversight helps protect public health by enabling timely access to affordable, safe, effective, and quality‑assured health products. This includes promoting collaboration between regulators, sharing work and information, and using reliance and harmonization approaches to reduce duplication and improve efficiency.

WHO also focuses on strengthening activities that take place after products are approved. This includes building strong and modern pharmacovigilance systems to monitor the safety of health products, as well as effective post‑marketing surveillance to prevent, detect, and respond to substandard and falsified medicines. Supporting quality control laboratories at national and regional levels, and encouraging reliance mechanisms to avoid unnecessary repeat testing of vaccines and other biological products, are key parts of this work. All of this helps ensure a steady supply of safe, effective, and high‑quality medical products across countries.

Over the years, we have played a crucial role in improving global public health by ensuring access to priority quality-assured, cost-effective health products. To date, more than 1700 products have been prequalified, helping to treat and protect millions of people in LMICs.

By focusing on public health needs, this approach speeds up access to essential products, encourages competition between manufacturers, and helps bring prices down, making large‑scale procurement possible. This allows countries to use their health resources more effectively and achieve better health outcomes. Beyond assuring product quality, the WHO Prequalification Programme has also helped guide innovation and early product development.  The programme has also helped raise manufacturing standards in low- and middle‑income countries, with a growing number of manufacturers in these countries achieving prequalification.

Overall, the WHO Prequalification Programme is a key part of universal health coverage and global health security, helping ensure that everyone has access to safe, effective, and reliable health products.