WHO Prequalification of In Vitro Diagnostics Programme–Results of dossier assessment and acceptance of action plan •Not applicable for abbreviated PQ assessment –Results of inspection

WHO Prequalification of In Vitro

Diagnostics Programme

AMDS Annual Stakeholders and Partners Meeting

29-30 September 2014

Anita Sands Prequalification Team – Diagnostics Assessment

Department of Essential Medicines & Health Products

2

AMDS Annual Partners Meeting | 29-30 September 2014

WHO prequalification prioritization criteria

Current prioritization criteria Rationale

Already listed on WHO/UN procurement scheme

and procured by UN organizations in significant

levels

Ensure continuity of supply and quality of

products procured

Assist diagnosis of infection with HIV-1/HIV-2,

malaria and hepatitis C

Focus on priority disease areas – highest

historical procurement

Rapid test format Bringing testing closer to the community

Original product manufacturers Ensure known supply chain; no duplication of

effort, best possible prices

Few other prequalified products exist in the

product category such as CD4, viral load

Focus on unmet market / procurement needs

Adult male circumcision devices Focus on the needs of WHO disease

programmes

Other criteria dependent on changing global health needs, the particular needs of WHO Member States,

and the emergence of new and relevant diagnostic technologies.

3


WHO full prequalification assessment

Pre-submission form

Dossier review Site inspection Laboratory

evaluation

Dossier incomplete

Prequalification decision

Dossier complete

Dossier screening

Priority product

Yes

No

4


Abbreviated WHO prequalification assessment

Pre-submission form

Abbreviated

site inspection

Laboratory

evaluation

Prequalification decision

Yes

Full PQ

assessment

No

Yes

Priority product

No

Decision on

abbreviated PQ

assessment

5


Abbreviated prequalification assessment procedure

(previously known as fast-track)

Categories of products submitted to PQDx:

– Scenario 1

• Version submitted for PQ has been stringently assessed

– Scenario 2

• Version submitted for PQ has not been stringently assessed but a

regulatory version exists that has been

– Scenario 3

• Version submitted to PQ has not been stringently assessed

Where stringent assessment has been conducted by

founding member of GHTF

• CE (List A, Annex II), FDA (PMA or BLA), Health Canada (Class IV), TGA

(Class 4), Japan (Minister's approval)

6


Prequalification: decision

Final prequalification outcome depends on:

– Results of dossier assessment and acceptance of action plan

• Not applicable for abbreviated PQ assessment

– Results of inspection and acceptance of action plan

– No level 5 nonconformities outstanding for either dossier or 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

Change notification for WHO prequalified IVDs is obligatory

7


List of WHO Prequalified Products

List of diagnostics eligible for WHO procurement

http://www.who.int/diagnostics_laboratory/procurement/purchase/en/

WHO list of prequalified product updated as required

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

8


Current status for HIV RDTs

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

9


Current status for HIV EIAs and other formats


10


Current status for HIV/Syphilis RDTs


11


Current status HCV IVDs


12


Current status HBsAg IVDs


13


Current status CD4 IVDs


14


Current status HIV Virological IVDs


15


WHO post-market surveillance for IVDs

WHO is developing

guidance for reactive and

proactive post-market

activities

Post-market surveillance

continually monitors the

safety, quality and

performance of an IVD once

it is placed on the market

WHO will launch normative

guidance in December 2014

WHO prequalified product

Reactive PMS

Field Safety Notice

Complaints Lot verification testing

Proactive PMS

Field Safety

Corrective Action

16


Reactive PMS: complaint reporting

In settings where regulation for IVDs is poor or an NRA for

IVDs doesn't exist, WHO coordinates IVD complaint

reporting from users to manufacturers

WHO receives complaints for WHO prequalified products

– Using the WHO IVD complaint form

– http://www.who.int/diagnostics_laboratory/procurement/complaints

/en/index.html

WHO will ensure that the manufacturer undertakes the

appropriate investigation and Field Safety Corrective Action

(FSCA), if required

– Field Safety Notices may need to be issued to the field

17


Proactive PMS: lot testing

QC lot release testing should be carried out by the

manufacturer prior to shipment from the manufacturing site

WHO will develop guidance on lot verification testing for

– Sampling of test kits from central medical stores, prior to

distribution to testing sites

– Sampling of test kits from the field

Guidance to be developed

– Sampling frame (systematically or random)

– Specimen panels required

– Acceptance criteria

18


Contact us

Contact us by email

– [email protected]

Sign up to our mailing list

– By emailing

[email protected]

Check our website

– http://www.who.int/diagn

ostics_laboratory/evaluati

ons/en/

Documents

WHO Prequalification of In Vitro Diagnostics Programme–Results of dossier assessment and acceptance of action plan •Not applicable for abbreviated PQ assessment –Results of inspection