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A streamlined approach to the

WHO Prequalification of

In Vitro Diagnostics Programme: Overview

Copenhagen, Denmark 22-25 September 2014

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Dept of Essential Medicines & Health Products: structure


2

Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers

Essential Medicines and

Health Product [EMP]

Essential Medicines and

Health Product [EMP]

Policy, Access and Use

[PAU]

Policy, Access and Use

[PAU]

Regulation of Medicines

and other Health

Technologies

[RHT]

Regulation of Medicines

and other Health

Technologies

[RHT]

Technologies Standards

and Norms

[TSN]

Technologies Standards

and Norms

[TSN]

Regulatory Systems

Strengthening

[RSS]

Regulatory Systems

Strengthening

[RSS]

Prequalification Team

[PQT]


[PQT]

Safety and Vigilance

[SAV]


[SAV]

Public Health,

Innovation and

Intellectual Property

[PHI]

Public Health,

Innovation and


[PHI]

WHO Prequalification Team: structure


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Essential Medicines

and Health Product

[EMP]

Essential Medicines

and Health Product

[EMP]

Policy, Access and

Use

[PAU]

Policy, Access and

Use

[PAU]

Regulation of

Medicines and other

Health Technologies

[RHT]

Regulation of

Medicines and other

Health Technologies

[RHT]

Technologies

Standards and

Norms

[TSN]

Technologies

Standards and

Norms

[TSN]

Regulatory Systems

Strengthening

[RSS]

Regulatory Systems

Strengthening

[RSS]

Prequalification

Team

[PQT]

Prequalification

Team

[PQT]


[SAV]


[SAV]

Public Health,

Innovation and


[PHI]

Public Health,

Innovation and


[PHI]

Vaccines Assessment

Vaccines Assessment

Medicines AssessmentMedicines

AssessmentDiagnostics Assessment

Administrative teamAdministrative team

InspectionsTechnical

Assistance

Coordinator’s office


> Consolidated prequalification team aiming at

> Cross-product stream learning

> e.g. extension of ERP process to new product categories

> e.g. bigger pool of external experts and testing laboratories

> e.g. PQDx benefit from medicines and vaccines experience to improve efficiency

EMP reorganization: single PQ programme for further impact & restructured regulatory units


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> Enhanced management & operations

> e.g. quality management system

> e.g. administrative efficiencies, incl. financial management

> Better relationship with stakeholders

> e.g. single voice when dealing with national regulatory authorities

> e.g. increased transparency around processes and outcomes

> PQDx weaknesses

PQDx streamlining: Review of PQDx experience and analysis of gaps and challenges


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> Timelines

> Transparency (pass/fail criteria, fast tracking, post-PQ)

> Guidance and specific information to Mx

> Communications with stakeholders

> Overloaded pipeline

> Jan-Jun 2014: PQDx Programme underwent streamlining to:

Prequalification of IVDs streamlining


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> Increase efficiency (timelines, focus on active applications)

> Improve transparency (requirements, process)

> Strengthen work with key partners (NRAs, manufacturers, procurement and other agencies)

Prequalification of IVDs streamlining


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ProcessProcess

Product

dossier

Product

dossier

Site

inspections

Site

inspections

Lab.

evaluation

Lab.

evaluation

stepssteps

roundsrounds decisiondecision

feesfees

Critical sectionsCritical sections

NC gradingNC grading

planningplanning

IMDRFIMDRF

Cap. buildingCap. building

Working with partnersWorking with partners

efficiencyefficiency transparencytransparency

> PQDx assessment:

What are the changes to the process?


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> Full assessment (see flowchart)

> Abbreviated assessment (see flowchart)

Full prequalification assessment: process


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Dossier review Site inspection

Dossier incomplete

Laboratory evaluation

Prequalification decision

Dossier complete

Dossier screening

Priority product

Yes

No

Pre-submission form Updated PSF asks for more detailed

information on regulatory versions of

the product submitted to determine if

eligible for abbreviated PQ assessment

Abbreviated prequalification assessment


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Pre-submission form

Abbreviated site inspection

Laboratory evaluation


Yes

Full PQ assessment

No

Yes

Priority product

No

Decision on abbreviated PQ

assessment

> Final prequalification outcome depends on:



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> Results of dossier assessment and acceptance of action plan

> Results of inspection(s) and acceptance of action plan

> No level 5 nonconformities outstanding for either dossier or for inspection

> Meeting the acceptance criteria for the laboratory evaluation

> WHO PQDx Public Report is posted on WHO website and product is added to the list of WHO prequalified products

> Product is then eligible for WHO and UN procurement

> Efficient and timely prequalification of quality-assured diagnostics

Results of streamlined WHO PQDx assessment


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> Fewer steps

> Defined timelines

> Defined number of rounds

> Improved scheduling

> More interactions with Mx including more teleconferences at critical steps

> Division between PQDx assessment and assistance to Mx

> More transparent PQDx assessment process in place

> Additional guidance to assist Mx, WebEx briefings, sample dossiers, training plan for priority topics

> Robust capacity building programme in place through TA group:

> advisory visits to tackle specific gaps

> training programme to address most common PQ issues

Cleared pipeline

> Updated Overview of the Prequalification of IVDs assessment

PQ overarching documents published


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> Abbreviated prequalification assessment for IVDs (previously FT)

> A risk based approach for the assessment of IVDs (based on GHTF/SG1/N046:2008 Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices)

> Risk based classification of diagnostics for WHO Prequalification" (based on GHTF/SG1/Principles of In Vitro Diagnostic (IVD) Medical Devices Classification)

> WHO procedure for changes to a WHO prequalified in vitro diagnostic" and Changes notification form

> Updated Pre-submission form and Instructions

> Communications - Information for manufacturers and other stakeholders

Prequalification of IVDs streamlining: working towards


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> Improved guidance

> WebEx

> Website

PQDx streamlining completed but additional guidance to be published

Working with Mx and NRAs

> WHO website updates the status of each product undergoing PQDx assessment monthly

PQDx assessment status for all products


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http://www.who.int/diagnostics_laboratory/pq_status/en/index.html

> Onus on manufacturer and NRA, but often poorly executed

Post-market surveillance of WHO PQed IVDs


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> http://www.who.int/diagnostics_laboratory/procurement/complaints/en/index.html

> WHO coordinates complaints through the "WHO PQDx IVD complaint form" for end users to report issues

> WHO guidance on post-market surveillance is forthcoming

> GHTF/SG2-N54R8:2006

> GHTF/SG2-N57R8:2006

> Medical Devices Post Market Surveillance: Global Guidance for Adverse Event

Reporting for Medical Devices

> Medical Devices Post Market Surveillance: Content of Field Safety Notices

> Contact us by email

Contact us


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[email protected]

> Sign up to our mailing list

By emailing [email protected]

http://www.who.int/diagnostics_laboratory/evaluations/en/

> Check our website

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