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. 

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. 

Change assessment target timelines

The timeline for each step of change assessment are indicated in the table below.

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.

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.