WHO PREQUALIFICATION PROCESS SCORECARD: 2025

The WHO PQ team established and publicly shared KPIs for 2023–2025 for each product stream and published a 2024 report indicating whether it met these KPIs, which showed that the majority (about 82 percent) of KPIs across product streams had been met in 2024.

In the 2024 report, WHO lists which KPIs were met and unmet for each product stream, in addition to reporting-only (RO) indicators that the PQ team measured but did not set a pre-defined threshold for success. These indicators are reported for the KPI report but not counted as met or unmet. Thus, they are not reflected in the summary counts in this report card.

The establishment, review, and regular reporting of KPIs is critical to ensuring that the WHO PQ program is rigorously monitoring performance, identifying areas for improvement, and strengthening transparency and accountability for stakeholders, including manufacturers, researchers, and WHO member states. These actions demonstrate WHO’s commitment to improving effectiveness and adapting to evolving global health challenges. However, the 2026-2028 list of KPIs has not yet been posted on the PQ website.

All KPIs were listed for the Immunization Devices (IMD) product stream, and the majority of its KPIs (2/3 or 67 percent) were met in 2024. (Two targeted KPIs were met, one was unmet, and one was RO.)

All KPIs were listed for the In Vitro Devices (IVD) product stream, and the majority of its KPIs (5/8 or 63 percent) were met in 2024. (Five targeted KPIs were met, three were unmet, and two were RO.)

All KPIs were listed for the Medicines product stream, and the majority of its KPIs (13/15 or 87 percent) were met in 2024. (Thirteen targeted KPIs were met, two were unmet, and three were RO.)

All KPIs were listed for the Vaccines product stream, and the majority of its KPIs (5/6 or 83 percent) were met in 2024. (Five targeted KPIs were met, one was unmet, and two were RO.) Since last year, WHO eliminated the KPI for this product stream that measured the number of vaccines prequalified through PQ’s collaborative registration procedure (CRP), where national regulatory authorities can access product assessment reports from stringent regulatory authorities or PQ to accelerate the assessment and registration of medical products in participating countries. The CRP process is still counted as a KPI in other relevant product streams.

All KPIs were listed for the Vector Control Products (VCPs) product stream, and the majority of its KPIs (11/13 or 85 percent) were met in 2024. (Eleven targeted KPIs were met, two were unmet, and one was RO.)

All KPIs were listed for the Inspection Services product stream, and all its KPIs (6/6) were met in 2024. (Six targeted KPIs were met, zero were unmet, and one was RO.)

The WHO PQ program’s efforts to create and share pipelines of products currently undergoing PQ evaluation for each product stream are essential for transparency, providing manufacturers and health decision-makers with valuable insights into where products stand in the process. Currently, WHO publishes pipelines for only three out of five product streams. Additionally, there are inconsistencies in the formatting and in the level of relevant information provided across product stream pipelines, which can create confusion and hinder accessibility.

With no publicized pipeline for the IMDs product stream, it is unclear which IMDs are undergoing PQ evaluation or their status in the process. However, the PQ team has outlined steps to build a product pipeline in 2026.

The IVD product stream lists pipelines for diagnostics under assessment, though the level of detail and frequency of updates vary across products. Some pipelines provide comprehensive information, such as each product’s current stage in the PQ process, the responsible party for the next step (e.g., the PQ team or the manufacturer), the product’s application number, and the date of the last update. Others are partially complete or entirely blank.

The Medicines product pipeline exists but lacks the level of detail and understanding that other product pipelines provide (i.e., the Medicines product pipeline does not list product application numbers or the role of relevant parties and their next steps). Furthermore, it does not indicate when the Medicines pipeline was last updated, so it is unclear how relevant or appropriate each product’s status is in the PQ process. Without each product’s application number, it may be difficult for manufacturers to reference their product on the product pipeline.

With no publicized pipeline for the Vaccines product stream, it is unclear which vaccines are undergoing PQ evaluation or their status in the process.

The VCPs product stream pipeline exists and lists the product’s current state in the PQ process and the application number, but it lacks details on the responsibility party for the next step (e.g., the PQ team or the manufacturer). Furthermore, it does not indicate when the pipeline was last updated, so it is unclear how relevant or appropriate each product’s status is in the PQ process.

The Inspection Services product stream conducts inspections to assess and verify compliance of a manufacturer/laboratory and publishes completed inspection service reports rather than product pipelines, thus it has not been examined in this scorecard.

Dossier preparation materials provided by WHO are critical for manufacturers navigating the PQ assessment process. While WHO provides these materials across most product streams, inconsistencies in the content and depth of information for dossier preparation materials across the different product streams may create confusion in completing dossiers. Standardizing, as is feasible, and ensuring uniform access to comprehensive dossier preparation guidance could promote clarity and efficiency in the PQ process.

Dossier preparation guidance for the IMD product stream is available, comprehensive, and functional compared to other product streams. The WHO PQ site offers comprehensive information on submitting a dossier for IMD products, with clear details, functional hyperlinks, and relevant example dossiers. Manufacturers seeking to submit IMD dossiers have ample resources to do so via the WHO PQ site. PQ also introduced a new resource for the IMDs product stream that consolidates key policies and procedures to help manufacturers navigate the application process.

Dossier preparation guidance for the IVD product stream is available, comprehensive, and functional compared to other product streams. However, while example dossiers or templates are provided, there are some inconsistencies in PQ process terminology, which may confuse product developers. For example, the IVD dossier preparation information is posted under the “Pre-Submission Form” information rather than “product dossier.” Under the “Pre-Submission Form,” the IVD product stream lists a comprehensive guidance document. Notably, the IVD product stream also includes a detailed target PQ process timeline to guide applicants’ expectations; a feature other product streams could benefit from emulating.

The Medicines product stream offers substantial information about the PQ process through many guidance documents and templates, including example dossiers. This product stream has two types of products, and dossier preparation materials are available for both product types.* PQ also introduced a new resource for the Medicines product stream that consolidates key policies and procedures to help manufacturers navigate the application process. Additionally, PQ offers guidance to submit dossiers for Medicines through its electronic Common Technical Document (eCTD) facility, which offers a standard format for submitting regulatory information to health authorities, as part of its ePQS portal.

*The Medicines product stream comprises two forms of Medicines: Finished Pharmaceutical Products (FPPs) and Active Pharmaceutical Ingredients (APIs). An API can be used in the manufacturing of an FPP, for which dossier guidance documents are also provided. 

Dossier preparation guidance for the Vaccines product stream is available and functional, though less comprehensive compared to other product streams. The WHO PQ site offers some information on submitting a dossier for Vaccine products, steps to the dossier process, and deadlines for submission. However, this product stream lacks details, examples/templates, and some hyperlinks are inactive. PQ also offers guidance to submit dossiers for Vaccines through its eCTD facility, which offers a standard format for submitting regulatory information to health authorities as part of its ePQS portal.

Dossier preparation guidance for the VCP product stream is available, comprehensive, and functional compared to other product streams. The WHO PQ site offers comprehensive information on submitting a dossier for VCPs, with clear details and functional hyperlinks, but it lacks examples/templates. PQ also introduced a new resource for the VCPs product stream that consolidates key policies and procedures to help manufacturers navigate the application process.

Usually, inspections are carried out in connection with a prequalification application (e.g., product dossier) and do not require their own individual dossier.

The WHO PQ program provides complete lists of prequalified products across all product streams, including Immunization Devices, In Vitro Devices, Medicines, Vaccines, and Vector Control Products, as well as finalized inspection reports under the Inspection Services stream. This year, the PQ team has made several updates to the IMDs product stream, offering a one-stop-shop with the updated catalogue of IMDs, product selection tools, and procurement guidance.

The absence of dossier submission dates on the WHO PQ site hampers stakeholders’ ability to accurately gauge the timeline of the PQ process. These dates are crucial for manufacturers and researchers to plan resources and anticipate milestones, ensuring transparency and efficiency in the PQ process.

Launched in September 2025, the ePQS portal aims to enhance transparency and functionality to help facilitate the PQ process for applicants. While the launch of ePQS was highly anticipated after delays last year, access to the portal’s operational details and functions has remained limited, creating uncertainty about whether WHO PQ has fulfilled its commitments for the platform, including establishing a single repository for applications, sharing process-related milestones with manufacturers, and improving the dossier submission process on the PQ website.