PREQUALIFICATION ASSESSMENT AND CHANGE ASSESSMENT TARGET DEADLINES Prequalification of In Vitro Diagnostics

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PQDx_300 v1 21 July 2017

PREQUALIFICATION ASSESSMENT AND CHANGE ASSESSMENT TARGET

DEADLINES

Prequalification of In Vitro Diagnostics

P r e q u a l i f i c a t i o n T e a m - D i a g n o s t i c s

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WHO/EMP/RHT/PQT/2017.05

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PQDx_300 v1 21 July 2017 Page 1

1. Introduction

WHO Prequalification of In Vitro Diagnostics (IVDs) undertakes a comprehensive quality assessment of individual IVDs through a standardized procedure aimed at determining if the product meets WHO prequalification requirements¹. Once a product is prequalified, WHO undertakes an assessment of all reportable changes that are made to the product to ensure that they continue to meet WHO prequalification requirements.

Each step of the prequalification assessment and change assessment process should be completed within defined target deadlines which have been set with the aim of expediting the prequalification assessment and facilitating access to quality IVDs.

This document outlines the:

• target deadlines and deadline extensions for the abridged and full assessment pathways for an IVD under WHO prequalification assessment;

• target deadlines and deadline extensions for assessment of changes to prequalified IVDs; and

• process for requesting deadline extensions.

2. Intended audience

This document provides manufacturers with detailed information on target deadlines for the WHO prequalification assessment and change assessment.

3. Full prequalification assessment target deadlines

The WHO target deadlines for full assessment are:

 270 WHO calendar days, if the alternative performance evaluation pathway is selected by the manufacturer; and

 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 aforementioned target deadlines 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.

Figure 1 and Table 1 describe deadlines for all the different steps of the full prequalification assessment.

1 For further information see WHO document PQDx_007 Overview of the WHO Prequalification of In Vitro Diagnostics assessment

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Table 1 describes the individual target response times for WHO and the maximum allowable times for the manufacturer for each stage of the application and review process. The dossier review, manufacturing site(s) inspections and performance evaluation occur in parallel. Review is dependent on payment of the required fees.

Stage of assessment Maximum time allowed (calendar days) to provide a response

WHO Manufacturer

Pre-submission stage²

Pre-submission form review 30 N/A

Additional information submission N/A 30

Additional information review 30 N/A

Dossier screening³

Dossier submission N/A 30

Dossier screening 30 N/A

1^st supplement submission N/A 30

1^st supplement screening 30 N/A

2^nd supplement submission N/A 30

2^nd supplement screening 30 N/A

2 commences after receipt of the pre-submission form

3 Commences with the request to submit the product dossier

270/350 WHO calendar

days 60 WHO calendar days Maximum WHO time

Labelling review

Performance evaluation

Assessment Phase Dossier screening Pre-submission form

Site inspection

Prequalification decision Dossier review

90 WHO calendar days

Figure 1 Full prequalification assessment deadlines

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Prequalification assessment stage (Note: these stages are conducted in parallel) Dossier review⁴

Dossier review 90 N/A

CAP 1 submission N/A 30

CAP 1 review 30 N/A

CAP 2 review 30 N/A

Dossier amendment submission N/A As per agreement

with WHO

Dossier amendments review 60 N/A

Performance evaluation⁵

Evaluation scheduling 90

Evaluation and draft final report preparation

Analyte dependent (90 – 180 days)

N/A

Review of evaluation report N/A 30

Finalisation of evaluation report 30 N/A

Manufacturing site(s) inspection⁶

Stage 1 inspection 30 N/A

Stage 1 additional information submitted

N/A 30

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 review 30 N/A

CAP 2 review 30 N/A

Labelling review⁷

Labelling review 30 N/A

Revised labelling submission N/A 30

Revised labelling review 30 N/A

Prequalification decision⁸

4 Commences with the receipt of the assessment fee

5 Commences with the evaluating site request to submit kits

6 Commences with the receipt of QMS documents in the dossier

7 Commences when dossier review, site inspection and performance evaluation have been finalized

8 Commences after all assessment elements have been carried out

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Public report draft 30 N/A

Public report and labelling comments review

N/A 30

Public report finalisation and listing 30 N/A Table 1: Full prequalification assessment

Note: 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 PQ requirements and meeting the prescribed timeframes.

4. Abridged prequalification assessment target deadlines

The WHO target deadlines for abridged assessment are:

• 100 WHO calendar days, if the alternative performance evaluation pathway is selected by the manufacturer; and

• 180 WHO calendar days, if WHO coordinates the performance evaluation.

This includes WHO time to perform the manufacturing site(s) inspection, performance evaluation (if coordinated by WHO) and labelling review.

Figure 2 and Table 2 describe deadlines for all the different steps of the abridged prequalification assessment.

100/180 WHO calendar

days 60 WHO calendar days Maximum WHO time

Labelling review Performance evaluation

Assessment Phase Pre-submission form

Site inspection

Prequalification decision

Figure 2 Abridged prequalification assessment deadlines

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Table 2 describes the individual target response times for WHO and the maximum allowable times for the manufacturer for each stage of the application and review process. The manufacturing site(s) inspections and performance evaluation occur in parallel. Review is dependent on payment of the required fees.

Stage of assessment Maximum time allowed (calendar days) to provide a response

Pre-submission stage⁹

Pre-submission form review 30 N/A

Additional information submission N/A 30

Prequalification assessment stage Performance evaluation ¹⁰

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(s) inspection¹¹

Information package submission N/A 30

Information package review 30 N/A

Additional information submitted N/A 30

Scheduling of Stage 2 inspection Up to 6 months from

acceptance 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 review 30 N/A

CAP 2 review 30 N/A

Labelling review¹²

Labelling review 30 N/A

Revised labelling submission N/A 30

9 commences after receipt of the pre-submission form

10 Commences with the evaluating site request to submit kits

11 Commences with the receipt of the information package

12 Commences when dossier review, site inspection and performance evaluation have been finalized

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Revised labelling review 30 N/A

Prequalification decision¹³

Public report draft 30 N/A

Public report and labelling comments review

N/A 30

Public report finalisation and listing 30 N/A Table 2: Abridged prequalification assessment

Note: 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 PQ requirements and meeting the prescribed timeframes.

5. Change assessment target deadlines

Table 3 describes deadlines for all the different steps of the change assessment.

Stage of assessment Maximum time allowed (calendar days) to provide a response

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 additional information N/A up to 6 months Review of additional information and

acceptance decision

30 N/A

Table 3: Changes assessment deadlines

6. Process for requesting time extension

During prequalification, manufacturers may request extensions to a deadline set by WHO. Table 4 describes the maximum time extensions accepted, in principle, by WHO:

Stage of assessment Overall time

extension¹⁴ 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 3 months

13 Commences after all assessment elements have been carried out

14 Can be one extension or the sum of several extensions

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review)

Changes assessment for prequalified IVDs (change screening, change review, amendments)

6 months Table 4: Time extensions

Request for time extensions must be made in writing in advance of the submission deadline by the authorised contract with a justification for the need for a time extension.

NOTE: If a more substantial time extension is necessary to address WHO requests for information the manufacturer will be encouraged to withdraw from prequalification assessment and reapply when the requested information becomes available.

7. Failing to comply with target deadlines

Failure by manufacturers to comply with specified deadlines without justification or forewarning will result in a cancellation of the application.

Moreover, 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 deadlines, WHO will recommend to the manufacturer to withdraw the application from the assessment process.

8. Date of effect

These target deadlines apply to all applications for WHO prequalification assessment and applications for change assessment to a prequalified IVD received on and after 1 August 2017.

9. Contact information

Any inquiries regarding WHO Prequalification of IVDs should be addressed to:

diagnostics@who.int

PREQUALIFICATION ASSESSMENT AND CHANGE ASSESSMENT TARGET DEADLINES Prequalification of In Vitro Diagnostics