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3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008. Update and Future Directions of Prequalification of Diagnostics Dr Gaby Vercauteren Coordinator, Diagnostics and Laboratory Technology Essential Health Technologies Health Systems and Services .

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3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008

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3rd stakeholders meeting on prequalification geneva 4th february 2008

3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008

Update and Future Directions of Prequalification of Diagnostics

Dr Gaby Vercauteren

Coordinator, Diagnostics and Laboratory Technology

Essential Health Technologies

Health Systems and Services

the aim of prequalification of diagnostics
The aim of prequalification of diagnostics
  • To promote and facilitate access to safe and appropriate diagnostic technologies of good quality in an equitable manner.

WHO's Diagnostics activities

  • Assessment of the performance and operational characteristics of test kits
    • HIV tests since 1988
    • Hepatitis B tests since 2000
    • Hepatitis C test kits since 2000
    • Chagas tests since 2002
    • Syphilis tests since 2001
    • Malaria tests since 2002.
    • CD4 technologies ad hoc in 1996 and 2003
    • Alternatives to viral load started 2005
  • Provide technical information on various


global market for diagnostics is changing
Global market for diagnostics is changing


  • Outsourcing of production
    • Move to countries with less stringent regulations
  • Confusion about licensing of products
    • Re-branding of test kits (OEM)
    • Same name, but different production site, different quality norms
  • Easy to operate tests/methods
    • Near patient testing, hard to reach populations, non lab environments, tasks shifting
  • Humanitarian projects- initiative from companies
  • Availability of funds for diagnostics
who s response
WHO's response
  • Review of the prequalification process for diagnostics
  • As a more comprehensive approach was required ...
  • Align with global standards for assuring quality of diagnostics
prequalification of diagnostics new approach
Prequalification of Diagnostics – New approach
  • Through a rigorous process identify diagnostics that meet the quality standards
  • Harmonize the WHO prequalification process
    • More stringent dossier assessment of diagnostics
    • Inspection of the QMS at production site (ISO 13485/GMP)
    • Laboratory assessment of performance characteristics
    • Building capacity at country level (NRA and NRLs) and establishing post-market surveillance for priority diagnostics
  • Partnering with well known regulatory authorities and with key technical partners
pq strategic plan
PQ strategic plan

Objective 1:

  • increase number of diagnostics reviewed each year by expanding technical managerial and administrative capacity, and by improving efficiency of the PQ process

Objective 2a :

  • Create and/or refine norms and standards for prequalifying diagnostics

Objective 2b:

  • Prequalify diagnostics
pq strategic plan8
PQ strategic plan

Objective 2c:

  • Increase country capacity to effectively regulate diagnostics and diagnostics manufacturers to submit products for prequalification

Objective 3 :

  • Ensure financial sustainability of UN Prequalfication programme after project completion
priority diagnostics
Priority Diagnostics
  • HIV
  • Malaria
  • TB
  • Ongoing and new diagnostic markers
who ensuring improved access quality appropriate use of diagnostics
WHO - ensuring improved access, quality & appropriate use of Diagnostics

WHO departments and teams

  • Essential Health Technologies, (EHT)
    • Diagnostics and Laboratory technology; (DLT)
  • HIV department (HIV)
  • Stop TB, (STB)
    • TB strategy and operations (TBS)
  • UNDP/World Bank/WHO special Programme for Research and Training in Tropical Diseases, (TDR)
    • Product Development and Evaluation, (PDE)
  • Global Malaria Programme,(GMP), SCM
  • WPRO : Malaria, other vector borne diseases; (MVP)

Key priority for 2007-2012

Prequalification of Diagnostics

achievements 2007
Achievements 2007
  • New team in place
  • Expanded procedures developed
    • Forms-instructions-protocols
  • Process documents developed
    • SOP – check lists- letters
  • Quality Management System applied
  • Communication strategy
achievements 2008 start new process
Achievements 2008 start new process
  • Applications and dossier assessments, inspections, lab evaluations, HIV, malaria diagnostics
  • Plan and organize field sites VL and CD4 tests
  • Increase communication to key stakeholders and industry about PQ
achievements 200713
Achievements 2007

Diagnostics and Laboratory Technology

  • New team established in January 2007



prequalification project management team
Prequalification project management team
  • Diagnostics-Medicines and Vaccines
    • Bi-monthly meetings
  • 1 day meeting reviewed the 3 PQ processes:
    • Similarities
    • Differences
    • Opportunities for efficiency (web-based applications, tracking, etc)
  • Malaria diagnostics working group
    • Regular meetings
    • Improved collaboration
the communication strategy
The communication strategy
  • Communications mapping and analysis
  • Annual stakeholders meeting
  • Annual prequalification report
  • Prequalification web pages (FAQs)
  • Communications specific for target audiences
    • Manufacturers
    • Donors
    • NRA - NRL
    • Users
    • Buyers
key messages
Key Messages

Different elements of the case will be emphasized according to the different target audiences.

Prequalification of diagnostics:

  • facilitates the procurement of appropriate, quality diagnostics at reasonable cost for resource limited countries by UN and other agencies involved in procurement
  • reduces expenditure of human and financial resources on poor-quality, ineffective diagnostic technologies
  • contributes to the scaling-up of prevention and treatment programs, slowing of drug resistance and treatment failures
  • Empowers people at risk and/or infected with HIV/AIDS or malaria by assuring that the patient receives an appropriate diagnosis and consequently optimal treatment.

To increase awareness and maintain manufacturers' interest in submitting products for PQ and to encourage manufacturers to prepare PQ submissions adequately.

To urge manufacturers to focus on producing priority diagnostics, appropriate for resource-limited settings and to cater to both paediatric and adult populations.

To encourage compliance with GMS.

To encourage manufacturers to ensure adequate product maintenance and customer service locally.


PQ enables product to be included in UN Bulk Purchasing Scheme and reinforces global image of quality diagnostic.

Adequate submissions result in timely PQ.

Products that are not appropriate for resource limited countries or that are not considered priority will not be eligible for PQ.

Compliance with GMS is necessary for PQ.

PQ, in addition to local customer service will help to establish the diagnostic product in the market.


To urge donors to contribute to the purchase of not only medicines, but also diagnostics.

To maintain and increase financial support for diagnostics PQ.


Prevention and treatment scale-up initiatives rely on access to quality, affordable diagnostics.

The purchase of prequalified diagnostics is cost efficient spending of public funds.

The purchase of prequalified diagnostics should be a requirement.

diagnostics procurement issues
Diagnostics Procurement Issues

Promote use of pre-qualified diagnostics

  • Advocate for selected tendering of pre-qualified products
  • Advocate for link buyers and users
  • Technical guidance on procurement issues
    • Generic specifications
    • Maintenance contracts
  • Post-market surveillance mechanisms
communication updates
Communication Updates
  • Update prequalification of diagnostics
    • Issue 1 (general)
    • Issues 2- 8 ( topics identified, issues in preparation)
  • AIDS conference; Mexico 3-8 August 2008
    • Organize briefing session
prequalification of diagnostics process
Prequalification of Diagnostics Process


Manufacturer submits application

Application is screened

Manufacurer pays fee and submits dossier



Dossier is reviewed


Laboratory Evaluation

Manufacturing Site Inspection

Meets WHO requirements

Meets WHO requirements

Does not meet WHO requirements

Does not meet WHO requirements

Review of all information

Product is prequalified (eligible to tender with UN)

challenges for the dossier review
Challenges for the dossier review
  • Web based application system (lower priority)
  • Lack of stability data
  • Insufficient performance data
  • Lack or rudimentory Quality Managment System ( ISO 13485)


  • Guidance document on stability testing (CLSI)
  • Guidance document on performance data
  • Instructions for compilation of a dossier address these issues (organize some sessions)

What is a Quality Management System?

  • 'The system should ensure consistency and improvement of working practices, which in turn should provide products and services that meet customer's requirements.
  • ISO 9000 series is the most commonly used international standard that provides a framework for an effective quality management system.'
international organization for standardization
International Organization for Standardization

who uses ISO 13485?

  • US FDA Quality System (FDA 21 CFR Part 820) regulation now 'harmonized' with ISO 9001 and ISO 13485 (minor variations)
  • European Union
  • Therapeutic Goods Administration (TGA ) Australia
  • Health Care Canada
  • Global Harminization Task Force (GHTF)
    • Australia-Canada-EU-Japan-USA
  • Asian Harmonization Working Party (AHWP)
    • 16 Asian countries, including China, Korea, …
    • Alliance with GHTF
quality management of the project
Quality Management of the project

Continual Improvement of

The Quality Management System

Management responsibility

Analysis of feedback

Resource management

Satisfaction Customers

Customer requirements

Prequalification Assessment

achievements 200730
Achievements 2007

Quality Management Explained

  • policies, processes and procedures required for planning and execution of the prequalification assessment
  • integrates WHO processes and appliesa process approach
  • enables DLT to identify, measure, control and improve the prequalification processes that will lead to improved performance
challenges for countries and for the pq dx programme
Challenges for Countries and for the PQ Dx programme

Procurement Issues

  • Malaria
    • Large variety of rapid malaria diagnostic tests available,

… but which test to choose ?

  • HIV
    • Procurement HIV tests more established
    • Gaps in availability of pediatric diagnostics
potential inspections in 2008
Potential inspections in 2008
  • Priority for diagnostics currently procured by UN (Web buy list)
    • 32 HIV tests (20 rapid, 7 EIA and 5 confirmatory)
    • 53 Malaria tests (53 rapid)
  • Additional 7 manufacturers are of interest
  • Rapid tests have priority
  • 40 sites manufacture rapid tests
inspections site visits only 2008
Inspections (site visits only) 2008
  • Time per inspection mission:
    • 3 days on site of manufacture +2 days travelling time per mission
    • 5 days:1 site – 1 product, 6 days: 1 site- 2 products, 9 days: 2 sites – 2 products
  • Inspection team consists of
    • One WHO DLT staff member
    • 2 externally sourced inspectors
    • Inspector/s from the National Regulatory Authority
priority setting for laboratory assessment of diagnostics
Priority setting for laboratory assessment of diagnostics
  • Serological tests
          • HIV rapid tests
          • Malaria rapid tests
          • TB rapid tests (2009 …)
          • HIV incidence tests
  • CD4 technologies
  • Viral load and early detection in infants
          • filter paper approach
          • Alternatives
conclusion a more efficient programme
Conclusion: A more efficient programme
  • Application process
    • Generates valuable information
    • formalizes procedure and screens out products which are not UN priority or substandard
    • streamlines scheduling
  • Dossier review
    • screens out applicants with poor quality management
  • Assessment of QMS of production of diagnostics through site inspection
    • ensures a consistent product each time
  • Laboratory evaluation
    • (operational characteristics and performance)
  • PQ Diagnostics Programme operates under an internal QMS
capacity building
Capacity building
  • Capacity building National Regulatory Authorites
    • Pilots South Africa, China
    • Generic regulations
    • Strengthened national capacity for inspections
  • Capacity building National Reference Laboratories
    • Performance assessments
    • Batch release testing
  • Pilot Post-market surveillance
    • QA programmes for users
    • Tools to record problems
  • Guidance on Procurement and supply management
    • Selection of diagnostics
    • Tendering processes GFATM, UN agencies, key players
update the business plan
Update the business plan
  • Review of the business plan for prequalfication of diagnostics based on real costs
  • Short term – next 2 years
  • Longer term
future directions
Future directions
  • Expand range of diagnostics
    • TB
    • STI's – HPV tests
    • HIV incidence tests
  • Capacity building
    • NRA
    • NRL
  • Guidance to address found weaknesses
  • Expand Post market surveillance
  • Guidance on Procurement and supply management
    • Selection of diagnostics
    • Tendering processes GFATM, UN agencies, key players