In the interest of monitoring performance and increasing its capacity to report on that performance to its many stakeholders, the WHO Prequalification Team has developed new key performance indicators. These are now available for review and comment.
The attached documents — a narrative and summary table describing PREQUALIFICATION TIMELINE KEY PERFORMANCE INDICATORS — are draft documents that are being circulated for comments. The narrative provides background information on terminology, calculation methodology and framework while the summary table includes the targets for each proposed indicator.
When reviewing the documents the following points should be taken into account:
- The proposed algorithm for 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.
- Implementation of the proposed algorithm and of reporting under the new indicators is dependent on implementation of the proposed new IT system for WHO prequalification. Currently, the go-live of the new IT system is planned for October 2018. Reporting based on the new indicators cannot be delivered before that date.
- The proposed set of indicators may be modified following receipt and review of comments as well as consideration of any implementation issues.
- Although indicators have been developed with a view to applying them across all product types[1], start of implementation of reporting with these indicators across the product types will probably be staggered.
- Prequalification of male circumcision devices and immunization devices are currently not subject to performance measurement with respect to prequalification timeline. Putting the new performance metrics in place for these product types might therefore require additional time.
Finally, 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.
Comments on the key performance indicators can be submitted by email to prequal@who.int until 26 August 2017.
[1] 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