Prequalification of health products

Key facts

• Globally, 70% of countries have inadequate or weak regulatory systems to effectively oversee medicines and vaccines. The situation is even more concerning for other health products, such as diagnostic tests and other medical devices.
• WHO’s prequalification programme ensures that key health products for international procurement meet global standards of quality, safety, efficacy and performance.
• The prequalification programme started at WHO in 1987. As of end of 2025, more than 1700 health products are listed by WHO.
• The programme covers a wide range of health products, including medicines, vaccines, immunization devices and cold chain equipment, medical devices including in vitro diagnostics, vector control products, and snake antivenoms. Not every product is eligible for prequalification.
• Each year, a growing number of people in low- and middle-income countries have access to safer, quality-assured health products thanks to the WHO prequalification programme.
• Although WHO is not a regulatory authority, its prequalification programme has been recognized as a trusted benchmark for safety, quality and efficacy/performance.

Overview 

Ensuring access to safe, effective, and quality-assured health products is fundamental to global public health. Yet many countries lack the capacity for effective regulatory oversight, leaving populations with limited or no access to these critical products while exposing them to substandard or falsified ones.

Each year, United Nations (UN) agencies, international procurement agencies and nongovernmental organizations (NGOs), as well as Member States, purchase billions of US dollars’ worth of health products to deliver to people in resource-limited countries and humanitarian crisis settings. To help ensure these products are safe, effective and meet stringent quality standards, WHO established the Prequalification Programme (PQP). This initiative supports procurement agencies and countries in making informed decisions, enabling them to confidently purchase large quantities of quality-assured products from vetted manufacturers.

Originally launched in 1987 to support UNICEF’s vaccine procurement, the PQP has since expanded to cover medical devices such as immunization devices and in vitro diagnostics, cold chain equipment, medicines and vector control products. PQP also has a process in place to evaluate snake antivenom products for efficacy and to ensure quality standards are met for the manufacture of these products.

The process for each product stream consists of a transparent, scientifically sound assessment, which may include dossier review, product testing, product labelling and inspections of manufacturing sites or quality control laboratories, depending on the type of product.

The PQP plays a pivotal role in facilitating access to quality-assured health products in low- and middle-income countries (LMICs). By prequalifying products, WHO provides a trusted benchmark for UN and international procurement agencies, governments and other stakeholders, helping ensure that the health products they purchase are safe and effective.

Scope of the programme

PQP covers six product streams:

• vaccines: Initiated in 1987, WHO vaccines prequalification aims to ensure that vaccines used in immunization programmes are safe and effective, including in emergency situations and in response to novel disease outbreaks. It covers all vaccines required for routine immunization against 24 priority diseases. Procedures are in place to enable a standardized approach for streamlined and expedited assessment, including reliance on the responsible national regulatory authority; 
• immunization devices and cold chain equipment: Established in 2007, the WHO Immunization Devices, Performance, Quality and Safety (IMD-PQS) initiative guarantees that products used for vaccine transport, storage, monitoring, administration and disposal meet global standards. By prequalifying these products, WHO helps Member States and UN procurement agencies access reliable, quality-assured solutions – such as syringes, refrigerators and monitoring tools – for immunization programmes;
• medicines: Established in 2001, WHO medicines prequalification ensures that active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) are safe, efficacious and meet stringent quality standards. The programme initially focused on antiretrovirals to combat the HIV epidemic. Its mandate was later expanded to include selected medicines for malaria, tuberculosis, reproductive health, neglected tropical diseases, influenza, diarrhoea, and other therapeutic areas. It recently initiated prequalification of biotherapeutic products with a selection of products to treat certain types of cancer and human insulin for diabetes;
• medical devices’, including in vitro diagnostics (IVDs)’ prequalification aims to increase access in LMICs to products that meet internationally-recognized standards for quality, safety, and performance. The programme originated from the test kit evaluation initiative launched in 1988 and became operational as IVD prequalification in 2010. It covers a wide range of products for both endemic and epidemic diseases, such as HIV/AIDS, tuberculosis, malaria, and hepatitis B and C. Building on this foundation, WHO is progressively expanding the scope beyond IVDs to other medical devices. In 2025, prequalification of contraceptive devices (male and female condoms and intrauterine devices) was transitioned from UNFPA to WHO;
• vector control products (VCPs)’ prequalification assesses both VCPs and public health pesticide active ingredients to determine that they can be used safely and effectively and are manufactured to a high-quality standard. Products assessed are used for the prevention of vector-borne diseases and include bed nets, sprays, larvicides and other prevention-focused tools; and
• snake antivenoms: Since 2022, WHO has been conducting risk–benefit assessment for snake antivenoms, based on essential data on quality, safety, efficacy and performance, to support their safe and effective use – a product stream that no other regulatory authority oversees. Antivenoms are unique biological products that are currently the most effective treatments available for snakebite envenoming, a neglected tropical disease that claims as many as 80 000 to 140 000 lives worldwide every year.

Inspection services is an essential core function of the prequalification process, supporting all product streams by organizing, coordinating and conducting inspections. These inspections assess and verify compliance with international standards and norms for manufacturers, contract research organizations, and laboratories. Beyond initial prequalification, inspections serve as WHO’s key mechanism to ensure ongoing compliance of manufacturing sites across all prequalified product streams. They also help manage and respond to issues that arise throughout a prequalified product’s lifecycle, including complaints, out-of-specification results, and recalls.

Prequalification process

The prequalification process involves several stages, with some steps tailored to specific product types. It includes defined entry points for manufacturers, followed by rigorous scientific review and inspections of manufacturing sites to ensure compliance with WHO requirements for quality, safety, and performance. Products that meet these requirements are listed as prequalified and become eligible for procurement by UN agencies, governments, and partners. They are then subject to ongoing monitoring to ensure continued compliance throughout their lifecycle.

WHO publishes lists of prequalified products for each category along with a list of prequalified quality control laboratories. Summaries of assessment and inspection reports are also made publicly available.

The prequalification process for health products has seen significant progress with the introduction of tools such as the ePQS system and the planned transition to the electronic Common Technical Document.

More information on WHO’s prequalification process is available on the WHO Prequalification website.

In addition to prequalification, WHO conducts risk-based assessments of health products, including the Emergency Use Listing (EUL) for vaccines and IVDs and the Expert Review Panel (ERP) for IVDs and medicines. These mechanisms are designed to address urgent public health needs during emergencies and to help fill gaps in the availability of quality-assured products in specific disease areas.

Impact 

Over the years, WHO PQP has 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 listed, helping to treat and protect millions of people in LMICs.

The programme enables billions of dollars per year in donor-funded procurement of quality, safe and efficacious products, with vaccines accounting for nearly half. The impact of prequalification extends far beyond donor markets, as many countries also rely on PQP listings of products to guide national self-procurement decisions.

By prioritizing public health needs, WHO PQP accelerates access to essential health products, fosters competition among manufacturers and drives price reductions, enabling bulk procurement. It helps optimize health resources and ultimately improve health outcomes in LMICs.

Beyond product quality assurance, WHO PQP has been instrumental in guiding product innovation and early-stage development, such as bringing paediatric tuberculosis treatments to market and promoting HIV self-tests and the first dual active insecticide-treated bed net.

Additionally, the programme has significantly raised manufacturing standards in LMICs, with an increasing number of LMIC-based manufacturers successfully achieving prequalification. Today, over 40% of prequalified medicines and 50% of prequalified vaccines are produced by manufacturers in LMICs.

WHO PQP is a cornerstone of universal health coverage and global health security, ensuring that all people have access to safe, effective and quality health products.

Challenges 

Many countries around the world still lack the capacity to thoroughly evaluate the quality, safety and efficacy/performance of health products. At the same time, new and increasingly complex products – using new technologies and platforms – require specific skills for proper evaluation. This gap can pose a threat to global public health and delay access to essential health products in these countries. WHO PQP helps address this issue by providing a trusted and reliable assessment of priority health products.

Despite the successes of WHO PQP, key challenges remain:

• manufacturers may face difficulties meeting international standards, which can affect the time required for prequalification and increase the resources WHO must invest in product assessments; and
• sustained funding is required, alongside adapting to the evolving landscape of global health threats.

Addressing these challenges will require strengthened collaboration, targeted support for manufacturers of high priority products, expansion of prequalification to cover additional disease areas and streamlined regulatory pathways to accelerate access to new medical products.

WHO response 

WHO's response to the need for quality-assured health products is multifaceted.

WHO PQP conducts rigorous assessments of medical products, including laboratory testing, site inspections and assessment of suitability for use in the destination countries. Products that meet WHO requirements are listed as prequalified, making them eligible for procurement by UN agencies, global health partners and countries.

The programme also provides regulatory advice and support to manufacturers, helping them understand prequalification processes and requirements. This includes guidance on dossier preparation, compliance with international quality standards (such as good manufacturing practices and good clinical practices) and product testing.

WHO collaborates with national regulatory authorities (NRAs) to strengthen their capacity for product evaluation and oversight. This includes sharing full assessment and inspection reports with NRAs to facilitate national registration of prequalified products and to strengthen the training of NRA assessors and inspectors. Additionally, the PQP supports the development of global norms and standards, contributing to the harmonization of regulatory practices across countries.

Aligning WHO’s normative and prequalification processes is paramount. In 2024, the transition from a sequential to a synchronized assessment and policy/recommendation development process marked a significant step forward. Parallel processes are triggered whenever WHO identifies the need to issue a new or revised recommendation. This shift aims to ensure that while recommendations are being developed, products are assessed against PQ requirements within PQ target timelines, enhancing global access to essential health products and addressing inequities in countries that rely on WHO recommendations for the use of these products. 

WHO is committed to enhancing access to quality-assured health products by:

• continuously aligning prequalification eligibility with WHO technical programme priorities, ensuring timely access to quality-assured products;
• promoting regulatory reliance mechanisms to speed up product approvals globally; and
• expanding the PQ scope to include a broader range of essential emerging health products, reflecting the evolving epidemiology and addressing barriers to access.

Through these efforts, WHO ensures that the benefits of prequalification extend beyond individual products, fostering a global environment where quality health products are the norm.