WHO Prequalification of Medical

Products (medicines, vaccines,

diagnostics and medical devices)

Dr Lembit Rägo
Regulation of Medicines and Other Health Technologies
Essential Medicines and Health Products
World Health Organization
Geneva
Switzerland
ragol@who.int

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 Content
• Why we do it and how we do it?
• Organizational context
• Snapshot of activities
• Prequalification of medicines
• Prequalification of vaccines
• Prequalification of in vitro diagnostics and devices
• Prequalification of APIs
• Opportunities for the new joint prequalification programme
• Future vision on prequalification
• Conclusions

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 What is special about medical
products?
• Advances in science and technology create new
increasingly sophisticated medical products
• Neither health professionals nor patients/customers are
able to assess the quality, safety and
efficacy/performance of these products without special
education and training
• Result - medical products belong to most regulated
products
• In national settings subject to marketing approval
registration by competent authorities/national (regional)
regulatory authorities

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 Why we do it?
Modern health systems depend a lot on
availability and ACCESS
to safe, effective quality medical products

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 How we do it?
• WHO uses the same scientific principles to assess the
products safety, quality and efficacy/performance as well-
resourced national regulators:
- scientific assessment of documentary evidence for quality,
safety and efficacy
- site inspections for GMP/QMS, GLP and GCP
- Independent laboratory evaluation for IVDs
- control of variations to products and their manufacturing
processes
- post-approval monitoring of quality and safety
- where possible cooperating and relying on other regulators
decisions avoiding duplication

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 Prequalification is NOT stand alone activity
Many other technical work areas support and link to
prequalification (medicines, vaccines, in vitro diagnostics and
medical devices)
• Outside EMP – Disease oriented
departments/programs, IVB Department,
Strategic Advisory Group of Experts
(SAGE) on Immunization; Regional and
Country Offices
• Inside EMP – Norms and standards
work/Quality Assurance, Safety/Vigilance,
Activities to combat SFFC medical
products, NRA strengthening, Policy,
Innovation and technology transfer

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Structure of the new WHO/HQ
regulatory unit

Medicines - Lembit Rägo

Vaccines – David Wood
In Vitro Diagnostics – Irena Prat
Medical devices – Adriana Velazquez

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New prequalification team: five functional
groups

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 Major activities
• Prequalification of PRODUCTS
– Medicines (HIV/AIDS, malaria, TB, antivirals, RH, NTD etc.)
– Vaccines
– In vitro diagnostics, medical devices
• Prequalification of Active Pharmaceutical Ingredients (APIs)
• Prequalification of Quality Control Laboratories (for
medicines)
• Training and capacity building (regulators/manufacturers)
• Scientific advice and technical assistance to manufacturers

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Vaccines: Different starting point for PQ

GMP

Clinical data
Consistency of final
product characteristics

Meeting WHO requirements

and tender specifications

Reliance on NRA
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Polio end-game strategy
 Revision of procedure:
Alignment with medicines procedure
Total Volume of HIV Test Procurement PQ vs non-PQ
(all assay types, all data)

% PQ 69 79 86 81 83
% Non
PQ 31 21 14 19 17

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 Prequalification of APIs

Progress has exceeded expectations, due in part to the willingness

of manufacturers previously involved with PQP to participate.

  1 Jan 2011 1 Jan 2012 1 Jan 2013 28 Feb 2014

Cumulative number of 2 36 74 113

applications received

Cumulative number of 0 8 28 56
APIs Prequalified

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Prequalified/interested QCLs
(31 December 2013)

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Trainings in medicines and QC labs area:
More than 1900 participants annually

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 First ever joint PQ progress report published

http://www.who.int/immunization_standards
/vaccine_quality/pq_system/en/

http://apps.who.int/prequal/

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

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 What WHO PQ can offer to the regulators and
industries in the regions?
• Regulators
– Capacity building/training – improved technical knowledge and
skills incl. rotational fellows from NRAs
– Practice and experience for collaboration and cooperation
– Offers a lot of practical tools and guidelines
– Helps to build more credible regulatory systems
– Save resources
• Industries
– Access to international funds
– Better quality production/products/regulatory knowledge – better
access to markets
– Better image, more trust from procurement and regulators

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 Several mechanisms to help national approval
of prequalified products launched
–Joint assessment of selected
products with interested national
regulators (so far two rounds with
EAC regulators). "Two in one" or
PQ and NRA assessment
together
–Collaborative Registration
Procedure (CRP) which enables
to exchange confidential
regulatory information about PQd
products. "Second built on the
first" – NRA decision making
based on PQ assessment

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Opportunities for the new joint prequalification
programme
• "One structure, one entry" – more clear for all internal
and external parties/partners
• Harmonization and alignment between product streams,
learning from best practices, streamlined PQ for IVDs
• Increase in efficiency and reach out
• Better coordinated and more efficient working within the
organization, with national/regional regulators and other
partners e.g. confidentiality arrangements for PQT with
EU EMA and TGA under way
• Potential efficiency savings (admin costs etc.) …

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 Future vision on prequalification
• Consolidating the programmes for better efficiencies,
communication and reach out
• Increasing collaboration with NRAs for better access to
safe and effective quality products through shorter
timelines for approvals
• Facilitating harmonization and regulatory convergence
• Building national and regional regulatory capacities using
both continuity and change
• Transferring PQ functions to individual and regional
NRAs/NRA networks – from pilots to step by step
transfer of certain functions/product categories

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 Conclusions

• PQP is a powerful and effective mechanism to promote

access to quality medical products
• PQP saves lives
• PQP is not a replacement for national regulatory systems
but a (time limited) mechanism to promote access to
quality medicines
• PQP is a major proactive contributor to capacity building
both for regulators and local manufacturers
• PQP promotes collaboration and cooperation among
regulators, including relying on each others work and
reducing duplications

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 Selected references
• Ellen F. M. ‘t Hoena, Hans V. Hogerzeil, Jonathan D. Quick, Hiiti B. Sillo. A
quiet revolution in global public health: The World Health Organization’s
Prequalification of Medicines Programme. Journal of Public Health Policy,
16 January 2014
• Isabel Ortega Diego, Antony Fake, Matthias Stahl, Lembit Rägo. Review of
Quality Deficiencies Found in Active Pharmaceutical Ingredient Master
Files Submitted to the WHO Prequalification ofn Medicines Programme.
Pharm Pharm Sci (www.cspsCanada.org) 17(2) 169 - 186, 2014
• Nora Dellepiane, David Wood. Twenty-five years of the WHO vaccines
prequalification programme (1987–2012): Lessons learned and future
perspectives. Vaccine, 2014 (in press)
• Wondiyfraw Z Worku, John Gordon, Matthias MS Stahl, Lembit Rägo.
Deficiencies in generic product dossiers as submitted to the WHO
prequalification of Medicines Programme. Journal of Generic Medicines
9(2) 63–74, 2012

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