Update on WHO Prequalification of In Vitro Diagnostics Robyn Meurant and Mercedes Perez Gonzalez Prequalification Team – Diagnostics Assessment Essential Medicines and Health Products World Health Organization Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in vitro diagnostics, vaccines, finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control products Copenhagen, Denmark 18 to 21 September 2017 1 Copenhagen, Denmark 18-21 September 2017
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Update on WHO Prequalification of In Vitro Diagnostics Update 2 Improved aspect Impact Outstanding challenges Solutions for challenges Progress Streamlined process Focus on active
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Update on WHO Prequalification of In Vitro Diagnostics
Robyn Meurant and Mercedes Perez Gonzalez
Prequalification Team – Diagnostics Assessment
Essential Medicines and Health Products
World Health Organization
Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in vitro diagnostics, vaccines,
finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control
products
Copenhagen, Denmark
18 to 21 September 2017
1Copenhagen, Denmark 18-21 September 2017
2015 Update
2
Improved aspect Impact Outstanding challenges
Solutions for challenges
Progress
Streamlinedprocess
Focus on active applications, minimize effort into immature applications, assess more products, expanded programme scope
High priority products with immature applications / impact on overall timelines
Guidance, sample dossiers, technical assistance and training, TCs, WebEx
Expanded network for performance evaluations
Less burden for WHO CCs, wider utilisation of PQ outcomes through USAID
Timelines for specific technologies still challenging
Future laboratory evaluation pathway
Adoption of IMDRF principles
Alignment with best internationalpractice and reliance
MDSAP still in pilot, industry concerns over ToC/RPS
Further collaboration with IMDRF and other harmonization WPs
Implementedchanges assessment and PMS reporting
Better insight in post-PQ phase
Underreporting on vigilance, variable compliance for changes notifications
Updated changes assessmentprocedure, PMS WebEx, PMS training
2017 Progress Report
3
Improved aspect Impact Outstanding challenges
Solutions for challenges
Progress
Streamlinedprocess
Focus on active applications, minimize effort into immature applications, assess more products, expanded programme scope
High priority products with immature applications / impact on overall timelines
Guidance, sample dossiers, technical assistance and training, TCs, WebEx
Expanded network for performance evaluations
Less burden for WHO CCs, wider utilisation of PQ outcomes through USAID
Timelines for specific technologies still challenging
Future laboratory evaluation pathway
Adoption of IMDRF principles
Alignment with best internationalpractice and reliance
MDSAP still in pilot, industry concerns over ToC/RPS
Further collaboration with IMDRF and other harmonization WPs
Implementedchanges assessment and PMS reporting
Better insight in post-PQ phase
Underreporting on vigilance, variable compliance for changes notifications
Updated changes assessmentprocedure, PMS WebEx, PMS training
Streamlined process
Improvedaspect
Impact Outstanding challenges
Solutions for challenges
Progress
Streamlinedprocess
Focus on active applications, minimize effort intoimmature applications, assess more products, expanded programme scope
High priority products with immature applications / impact on overall timelines
Guidance, sample dossiers, technical assistance and training, TCs, WebEx
Streamlined processPre-submission form Pre-submission form
Dossier review Site inspection
Laboratory evaluation
Dossier incompleteDossier incomplete
PREQUALIFICATION DECISION
Dossier completeDossier complete
Dossier screeningDossier screening
Eligible productEligible product
YesYes
NoNo
Maintenance of PQ Status
Pre-submission form Pre-submission form
Site inspection Laboratory evaluation
Eligible productEligible product
YesYes
NoNo
Maintenance of PQ Status
PREQUALIFICATION DECISION
Abridged Procedure
Pre-submission form Pre-submission form
Site inspection Laboratory evaluation
Eligible productEligible product
YesYes
NoNo
Maintenance of PQ Status
PREQUALIFICATION DECISION
Abridged Procedure
Dossier AspectsDossier Aspects
Updates
• Increase in the number of malaria manufacturers
applying for WHO PQ
• Increase in the number of abridged PQ assessments
� Assessment of dossier aspects as part of the site
inspection
• Innovative products and new manufacturers continue to
apply to PQ
• Addition of new diseases requiring full PQ assessment
WHO Prequalified IVDs
• Overall
Prequalified
products: 67 IVDs
Products currently prequalified
HIV RDTs 16
HIV NAT Quantitative and qualitative 15
HIV Confirmatory Assays 3
HIV EIAs 13
HCV RDT 2
HCV NAT 1
HCV EIAs 3
HBsAg EIA 4
HIV/syphilis 1
CD4 Technologies 5
Malaria 12
Highlights
Prequalification:
•Prequalification of two HIV EID technologies:
–Performance evaluation conducted as a
collaboration between WHO, NHLS and CDC
under USAID/PEPFAR-WHO common quality
assurance mechanism.
•Prequalification of the first two HCV rapid diagnostic tests
•Prequalification of a HCV viral load assay
•Prequalification of the first HIV Self Test
Highlights
PQ scope expanded to include
• In 2016:HIV assays intended for self-testing
G6PD assays (for administration of primaquine
and tafenoquine for radical cure of P. vivax)
• In 2017 (applications to be accepted 1 January 2018):
Cholera RDTs
Highlights
New set of PQ documents
• Overview of the WHO PQ of IVDs Assessment
• PQ Assessment and Change Assessment Target Deadlines
• PQ Assessment and Changes Assessment Fees
• Eligibility Criteria for WHO PQ of IVDs
• Presubmission form IVDs
Purpose of the dossier – unique characteristics
13
Demonstrate that the manufacturer has considered the quality, safety and performance of in the countries where WHO PQ IVDs are procured
• Programmatic suitability: specific emphasis on issues of particular relevance to
resource-limited settings, such as:
� Stability of products (heat conditions)
� Adapted specimen type
� Labelling of products
� Ease of use (in terms of training
– and material)
• Performance evaluated in the global population
• Life cycle management of products
14
Update on dossier assessment – WHO perspective
• PQ working to increase transparency for manufacturers: through publication of WHO requirements, revision of WHO documents and alignment with other organizations, for example:
� Technical Specification Series
� Technical Guidance series
� Consultation with international experts on requirements for new eligible IVDs
� Influence on the development of new International Standards and reference panels
� Plans to update current “Instructions for compilation of a product dossier”
Highlights cont’d
Technical Guidance Series:• Standards applicable to the WHO Prequalification of IVDs
• Establishing stability of an IVD for the WHO Prequalification
• Principles of performance studies
• Test method validation of IVDs
• DRAFT Designing Instructions for use for IVDs
• DRAFT Panels for quality assurance and quality control of IVDs
Sample dossiers:• Sample Product Dossier for a CD4 IVD
• Sample Product Dossier for an IVD intended for HIV self-testing
• Sample Product Dossier for a Qualitative NAT to detect HIV-1 and HIV-2
• Sample Product Dossier for a Quantitative NAT to detect HIV-1 RNA
Technical Specifications Series:• HIV rapid diagnostic tests for professional use and/or self-testing