Key Performance Indicators for WHO Prequalification

In the interest of monitoring performance and increasing its capacity to report on that performance to its many stakeholders, the WHO Prequalification Team (PQT) has developed new key performance indicators (KPIs).

Taking into account the comments received during the consultation period, PQT has considered the following changes:

  • Adding a supporting indicator to measure the number of dossier review cycles needed for prequalification
  • Adding a supporting indicator to track the number of products withdrawn from the PQ list.

This version is now considered the final set of KPIs; however, the indicators, and proposed targets, will be reviewed in one year and may be modified following consideration of any implementation issues. A more detailed narrative and a Q&A to address all comments received will be published soon.

The documents available below include a summary table describing the PREQUALIFICATION TIMELINE KEY PERFORMANCE INDICATORS, with targets for each indicator. As mentioned in the narrative document, the targets for indicators have been set for 2018 and may be revised one year after implementation, to include new targets from 2019 onwards, once preliminary results have been collected and reviewed. The draft narrative document (to be revised soon) provides background information on terminology, calculation methodology and framework.

When reviewing the documents the following points should be taken into account:

  • Implementation of the new algorithm for PQ timeline calculation, and more specifically, for the split between WHO and manufacturer time, may affect prequalification timelines; i.e. “old” and “new” performance measures may not be directly comparable.
  • Reporting based on this new set of indicators will gradually start in 2018.
  • Due to delays in the PQT IT solution, PQT has allocated internal resources to ensure PQT reports on all indicators in 2019.
  • Implementation of the new algorithm and reporting under the new indicators will be greatly facilitated by the implementation of the new IT system for WHO prequalification. Although indicators have been developed with a view to applying them across all product types, the start of implementation of reporting with these indicators across the product types will probably be staggered.

The following products are considered:

  • API: active pharmaceutical ingredient
  • FPP: finished pharmaceutical product
  • FVP: finished vaccine product
  • IMD: immunization device
  • IVD: in vitro diagnostic
  • MCD: male circumcision device
  • VCAI: vector control active ingredient
  • VCP: vector control product