Timelines
Each step of the prequalification assessment and change assessment process should be completed by defined deadlines which have been set with the aim of ensuring that prequalification assessment is completed according to a defined timeline, thereby facilitating access to quality in vitro diagnostics (IVDs).
Although WHO can commit to respecting WHO deadlines, manufacturer time is outside of WHO's control. Nevertheless, WHO offers a number of mechanisms for assisting the manufacturers in understanding prequalification requirements and meeting prescribed deadlines. Contact diagnostics@who.int for further information.
Deadlines are applied to all applications for WHO prequalification assessment and applications for change assessment to a prequalified IVD (received on and after 1 August 2017).
Full prequalification assessment timelines
The WHO target timelines for full assessment are:
- 270 WHO calendar days, if the alternative performance evaluation pathway is selected by the manufacturer
- 350 WHO calendar days, if WHO coordinates the performance evaluation.
The pre-submission form review and dossier screening stages are used to confirm that the application is valid and complete and hence are not part of the prequalification assessment. The above timelines include WHO time to perform the dossier review, manufacturing site(s) inspection, performance evaluation (if coordinated by WHO), labelling review and to inform the manufacturer of the decision on listing.
The individual target response times for WHO, and the maximum allowable times for the manufacturer for each stage of the application and review process for full prequalification assessment, are given in Table 1. Dossier review, manufacturing site(s) inspections and performance evaluation occur in parallel.
Assessment stage | Maximum time allowed (calendar days) in which to provide a response | |
---|---|---|
WHO | Manufacturer | |
Pre-submission stage1 | ||
Pre-submission review | 30 | N/A |
Additional information submission | N/A | 30 |
Additional information review | 30 | N/A |
Dossier screening2 | ||
Dossier submission | N/A | 30 |
Dossier screening | 30 | N/A |
1st supplement submission | N/A | 30 |
1st supplement screening | 30 | N/A |
2nd supplement submission | N/A | 30 |
2nd supplement screening | 30 | N/A |
Prequalification assessment stage (Note: these stages are conducted in parallel) |
||
Dossier review3 | ||
Dossier review | 90 | N/A |
CAP 1 submission | DEFINE CAP N/A | 30 |
CAP 1 review | 30 | N/A |
CAP 2 submission | N/A | 30 |
CAP 2 review | 30 | N/A |
Dossier amendment submission | N/A | As per agreement with WHO |
Dossier amendment review | 60 | N/A |
Performance evaluation4 | ||
Evaluation scheduling | 90 | |
Evaluation and draft final report preparation | Analyte dependent (90–180 days) | N/A |
Review of evaluation report | N/A | 30 |
Finalization of evaluation report | 30 | N/A |
Manufacturing site inspection5 | ||
Stage 1 inspection | 30 | N/A |
Stage 1 additional information submitted | N/A | 30 |
Additional information review | 30 | N/A |
Scheduling of Stage 2 inspection | Up to 6 months from acceptance by WHO for assessment | Up to 6 months depending on availability of the manufacturer |
Stage 2 inspection | 3–4 | 3–4 |
Inspections report | 30 | N/A |
CAP 1 submission | N/A | 30 |
CAP 1 review | 30 | N/A |
CAP 2 submission | N/A | 30 |
CAP 2 review | 30 | N/A |
Labelling review6 | ||
Labelling review | 30 | N/A |
Revised labelling submission | N/A | 30 |
Revised labelling review | 30 | N/A |
Prequalification decision7 | ||
Public report draft | 30 | N/A |
Public report and labelling comments review | N/A | 30 |
Public report finalization and listing | 30 | N/A |
1 Initiated after receipt of the pre-submission form.
2 Initiated at time of request to submit product dossier.
3 Initiated following receipt of assessment fee.
4 Initiated with request from evaluating site to submit kits.
5 Initiated following receipt of quality management system documents in the dossier.
6 Initiated as soon as dossier review, site inspection and performance evaluation have been finalized.
7 Initiated after all assessment elements have been carried out.
Abridged prequalification assessment timelines
WHO timelines for abridged assessment are:
- 100 WHO calendar days, if the alternative performance evaluation pathway is selected by the manufacturer
- 180 WHO calendar days, if WHO coordinates the performance evaluation.
These include WHO time to perform the manufacturing site(s) inspection, performance evaluation (if coordinated by WHO) and labelling review.
The individual target response times for WHO and the maximum allowable times for the manufacturer for each stage of the application and review process are given below. The manufacturing site(s) inspections and performance evaluation occur in parallel.
Assessment stage | Maximum time allowed (calendar days) in which to provide a response | |
---|---|---|
WHO | Manufacturer | |
Pre-submission stage1 | ||
Pre-submission review | 30 | N/A |
Additional information submission | N/A | 30 |
Additional information review | 30 | N/A |
Prequalification assessment stage | ||
Performance evaluation2 | ||
Evaluation scheduling | 90 | |
Evaluation and draft final report preparation | Analyte dependent (90–180 days) | N/A |
Review of evaluation report | N/A | 30 |
Manufacturing site inspection3 | ||
Information package submission | N/A | 30 |
Information package review | 30 | N/A |
Additional information submitted | N/A | 30 |
Additional information review | 30 | N/A |
Scheduling of Stage 2 inspection | Up to 6 months from acceptance by WHO for assessment | Up to 6 months depending on availability of the manufacturer |
Stage 2 inspection | 3–4 | 3–4 |
Inspections report | 30 | N/A |
CAP 1 submission | N/A | 30 |
CAP 1 review | 30 | N/A |
CAP 2 submission | N/A | 30 |
CAP 2 review | 30 | N/A |
Labelling review4 | ||
Labelling review | 30 | N/A |
Revised labelling submission | N/A | 30 |
Revised labelling review | 30 | N/A |
Prequalification decision5 | ||
Public report draft | 30 | N/A |
Public report and labelling comments review | N/A | 30 |
Public report finalization and listing | 30 | N/A |
1 Initiated after receipt of the pre-submission form.
2 Initiated with request from evaluating site to submit kits.
3 Initiated following receipt of information pacakge.
4 Initiated as soon as dossier review, site inspection and performance evaluation have been finalized.
5 Initiated after all assessment elements have been carried out.
Change assessment target timelines
The timeline for each step of change assessment are indicated in the table below.
Assessment stage | Maximum time allowed (calendar days) in which to provide a response | |
---|---|---|
WHO | Manufacturer | |
Change notification screening | 30 | N/A |
Submission of additional data | N/A | 30 |
Screening of additional information | 30 | N/A |
Change assessment | 60 | N/A |
Submission of additioanal information | N/A | Up to 6 months |
Review of additional information and acceptance decision | N/A |
Process for requesting time extension
During prequalification, manufacturers may request extensions to any deadline set by WHO. The table below describes the maximum time extensions granted, in principle, by WHO.
Request for time extensions must be made in writing in advance of the submission deadline by the authorized contact with a justification for the need for a time extension. See In Vitro Diagnostics Key Contacts for relevant person(s) to contact.
If a more substantial time extension than is indicated in the table below is needed in order to respond to WHO requests for information, the manufacturer will be encouraged to withdraw from prequalification assessment and reapply when the requested information becomes available.
Assessment stage | Overall time extension |
Dossier screening and review phase (including screening, full review, corrective action plan and amendments requests) |
6 months |
Performance evaluation | N/A |
On-site inspection (inspections scheduling, stage 1 inspection, stage 2 inspection) | 6 months |
Prequalification decision (Public Report and labelling comments review) | 3 months |
Change assessment for prequalified IVDs (change screening, change review, amendments) | 6 months |
Failure to comply with deadlines
Failure to comply with deadlines without justification or forewarning from the manufacturer will result in cancellation of the application.
If WHO as result of the assessment considers that the amendments and actions required to fulfil WHO requirements cannot be submitted or completed within the maximum allowable timelines, WHO will recommend to the manufacturer to withdraw the application from the assessment process.