Guidance Document

 WHO/PQT

01 December 2017

Prequalification Timeline Key Performance Indicators (KPIs)— Summary Table —This document is a summary table of PREQUALIFICATION TIMELINE KPIs, containing details of indicatorsand targets. Targets 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. This should beread in conjunction with the full background information relating to prequalification (PQ) timeline indicators.
APPLICATION-BASED PERFORMANCE INDICATORS#Indicator% Target

Target time

Annual PQ cohort (products prequalified in a calendar year)
Products prequalified  for applications accepted after 1 January 2015, 2016 for APIs (i.e. the annual PQ cohort)
100 Number of products prequalified
101 Median number of dossier review cycles% of products prequalified for which the number
10270%
Target number of dossier review cycles: 3of dossier review cycles is at or below target
Time to prequalification (from acceptance for assessment to prequalification)  for applications accepted after 1 January 2015, 2016 for APIs
110 Median WHO PQ time
N/A
111 Median manufacturer PQ time
N/A
112 Median total PQ time
N/A
Full assessment:
270 calendar days, 350 calendar days for IVDs prequalified
70%% of products prequalified at or below target WHO
without the alternative laboratory mechanism
KPI 1(30% forPQ timeAbridged assessment:APIs)
100 calendar days, 180 calendar days for IVDs prequalified
without the alternative laboratory mechanism
Submission cohort (PQ applications submitted for PQ assessment in a calendar year)
PQ applications submitted for PQ assessment (i.e. the submission cohort)Number of PQ applications submitted for PQ
200
assessment
Time to screening first action
210 Number of screening first actions% of screening first actions taken at or below
KPI 2target time---80%

30 calendar days

Assessment cohort (PQ applications accepted for PQ assessment in a calendar year)
PQ applications accepted for PQ assessment (i.e. the assessment cohort)
Number of PQ applications accepted for PQ
300
assessment
Time to dossier first action
310 Number of dossier first actions% of dossier first actions taken at or below target
KPI 3.1
timeTime to inspection first action
320 Number of inspection first actions% of inspection first actions taken at or below
KPI 3.2
target time
Time to laboratory first action
330 Number of laboratory first actions% of laboratory first actions taken at or below
KPI 3.3
target time

Prequalification Timeline Key Performance Indicators (KPIs)--

90 calendar days, 120 calendar days for FPPs & APIs(due to fixed assessment sessions)

80%

--

80%

210 days--80%

180 days1

Guidance Document

 WHO/PQT#01 December 2017Indicator

Products prequalified
340 Number of products prequalified
341 Median number of dossier review cycles% of products prequalified for which the number342
of dossier review cycles is at or below target% TargetTarget time--70%

Target number of dossier review cycles: 3

Change assessment cohort (post-PQ change applications accepted for change assessment in a calendar year)
Post-PQ change applications accepted for change assessment (i.e. the change assessment cohort)
Number of post-PQ change applications accepted
400
for post-PQ change assessment
Time to post-PQ change first action
410 Number of post-PQ change first actions

KPI 4% of post-PQ change first actions taken at orbelow target time

-APIMF|major amendment: 90 days
APIMF|minor amendment: 60 days
APIMF|immediate notification: 45 days
FPP|major variation: 90 days
FPP|minor variation: 60 days
FPP|immediate notification: 45 days
IVD|reportable change: 90 days
Vx|major variation, type A: 90 days

80%

PQ list cohort (all prequalified products on the PQ lists at the beginning of a calendar year)
Prequalified products on the PQ lists (i.e. PQ list cohort)
500 Number of products on the PQ list
Number of products withdrawn after
501
prequalification

Prequalification Timeline Key Performance Indicators (KPIs)----2