Access to good quality IVDs WHO Prequalification and ......Global Access to Hepatitis Drugs and Diagnostics WHO Consultation with Industry 16 June 2014 Why we need PQDx Assuring the

Access to good quality IVDs

WHO Prequalification and Procurement

Robyn Meurant Department of Essential Medicines & Health Products

WHO Workshop on Global Access to Hepatitis Drugs and Diagnostics

16 June 2014

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Global Access to Hepatitis Drugs and Diagnostics

WHO Consultation with Industry 16 June 2014

Coordination – Department of Essential Medicines and Health Products.

Aim – promote and facilitate access to safe, appropriate and affordable IVDs of good quality in an equitable

manner.

Focus – IVDs for priority diseases

– suitability for use in resource-limited settings.

Methodology – Assessment of safety, quality, performance and programmatic suitability

– Advocacy for quality focused procurement

– Regulatory strengthening

Outputs – independent comparative data on the performance and operational characteristics of IVDs

– PQ assessment forms the basis of recommendations for WHO procurement.

Customers – WHO Member States

– UN agencies

– Funding and procurement agencies

What is the WHO Prequalification of Diagnostics Programme?

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Diagnostic Landscape

There are many diagnostic and monitoring assays

(IVDs) of high quality for Hepatitis B and C

Most have been developed and verified for use in

resource rich countries

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Challenges for LMICs

High number of tests and resources required

Physical distance between patients and clinic

Percent of population where testing not accessible

LIC 96%

MIC 84%

HCV diagnosis rate <10% (c.f. 50% HIC)

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Resource rich….

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Resource limited…

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It is not a level playing field….

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Why we need PQDx

Assuring the quality, safety and performance of a

diagnostic test in a pre-market setting is usually the role of

the regulator

Only 1/3rd of WHO Member States regulate IVDs

Of those that do, not all regulate effectively

– Poor understanding of regulation

– Poor enforcement

– Lack of capacity

– Long approval times

– No transparency in decisions

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Why we need PQDx

In the last decade, a significant amount of IVD

manufacturing has moved to countries with no or little

regulation

– A consequence has been a general reduction in quality

Companies with quality products do not/cannot compete in

bids against those without quality. Quality comes with a

cost!!

This creates an unlevel playing field when it comes to

procurement ….

– Quality often not considered (c.f. cost)

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Why we need PQDx

Different regulatory versions of the same product

Relates to the information associated with a

submission for approval by a regulatory

authority.

The submitted version is defined by all of the

documentation related to development,

manufacture, and intended use, labelling and

post market surveillance of the product and all

the documented evidence supporting the

safety and performance claims associated with

that submission.

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Why we need PQDx

Different regulatory versions of the same product

If any aspect of this documentation is different in any

way between the submissions to different regulatory

authorities or assessment bodies (US FDA, Health

Canada, a Notified Body for CE marking, etc.) it is

considered to be a different regulatory version.

A programme may not

be purchasing an

identical twin!

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WHO evaluation of IVDs

HIV assays since 1988

HIV assays - 1988

Hepatitis B assays - 2000

Hepatitis C assays - 2000

Syphilis assays - 2001

Chagas assays - 2002

Malaria assays - 2002

CD4 technologies ad-hoc in 1996 & 2003

The assessment of in vitro diagnostic (IVD) performance and operational characteristics commenced in 1988

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PQDx Launch – 2008

Shift from test kit evaluations to Prequalification of IVDs:

• More comprehensive assessment approach • Review of a product dossier;

• Laboratory evaluation of performance and operational characteristics; and

• Manufacturing site(s) inspection

• Alignment with global standards for assuring quality of diagnostics

Identify IVDs that meet the quality standards through a risk based assessment process

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Prequalification of In Vitro Diagnostics Programme

Pre-submission form

Dossier review Site inspection Laboratory

evaluation

Dossier incomplete

Prequalification decision

Dossier complete

Dossier screening

Priority product

Yes

No

Pre-submission form

Abbreviated

site inspection

Laboratory

evaluation

Prequalification decision

Yes

Full PQ

assessment

No

Yes

Priority product

No

Decision on

abbreviated PQ

assessment

Full prequalification assessment Abbreviated prequalification

assessment

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Prioritization of PQDx applications

Comment

Current prioritization criterion

Ensure continuity of supply and quality of

products procured

Already listed on WHO/UN procurement

scheme and procured by UN organizations in

significant quantities

Focus on priority disease areas – highest

historical procurement

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

malaria and Hepatitis B and C

Bringing testing closer to the community Rapid test format

Ensure known supply chain; no duplication of

effort, best possible prices

Original product manufacturers

Focus on unmet market / procurement needs Few other prequalified products exist in the

product category such as CD4, VL

Focus on the needs of WHO disease

programmes

Adult Male Circumcision Devices

New priorities: Emphasis on hepatitis C serology and molecular assays and TB assays

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How we assess IVDs for PQ

Risk based assessment

approach based on

GHTF/IMDRF guidance

Currently, all IVDs accepted

into the programme are

those that pose a high

personal risk and often a

high public health risk

IMDRF Classes C and D

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Who sets international standards?

Organization

International Organization for

Standardization (ISO)

ISO standards are recognised as means of

demonstrating conformity to the essential principles of

safety, quality and performance.

Global Harmonization Task Force (GHTF)

Comprised on national regulators & industry.

Issues guidance on specific topics related to medical

devices including IVDs.

International Medical Device Regulators

Forum (IMDRF) - replaced GHTF

Comprised of national regulatory agencies.

Maintains GHTF guidance documents.

Clinical and Laboratory Standards Institute

(CLSI)

Issues guidance documents specific for IVDs e.g. testing

processes, IVD manufacturing standards

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Prequalification: decision

Final prequalification outcome depends on:

– Results of dossier assessment and acceptance of action plan

– Results of inspection and acceptance of action plan

• no level 5 nonconformities outstanding

– 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

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Prequalification of In Vitro Diagnostics Assessment

Application by Manufacturer

Meets

Requirements

Dossier

Review

Manufacturing

Site Inspection

Laboratory

Evaluation

Product Prequalified

Post Market Surveillance

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Post-market surveillance

Proactive surveillance and reactive responses are the onus of the

manufacturer, but often poorly executed

WHO PQDx complaint form for end users to report issues

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

en/index.html

– GHTF/SG2-N54R8:2006

• Medical Devices Post Market Surveillance: Global Guidance for Adverse

Event Reporting for Medical Devices

– GHTF/SG2-N57R8:2006

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

Pilot project on PMS

– Regulatory capacity building

– Capacity building at the NRL level

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



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PQDx assessment status for all products

WHO website updates the status of each product

undergoing PQDx assessment monthly

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

.html

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UNITAID Diagnostic Landscape

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Role of WHO

To provide normative guidance to Member States on when

and how to use IVDs to guide clinical decision-making

To provide recommendations on quality and performance

of IVDs through the WHO Prequalification of Diagnostics

programme according to international standards

To increase in-country capacity to effectively regulate & to

monitor quality of diagnostics in their market

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Contact us

Contact us by email

[email protected]

WHO Prequalification of In

Vitro Diagnostics programme

website

http://www.who.int/diagnostics

_laboratory/evaluations/en/

Documents

Access to good quality IVDs WHO Prequalification and ......Global Access to Hepatitis Drugs and Diagnostics WHO Consultation with Industry 16 June 2014 Why we need PQDx Assuring the