TITLE from VIEW and SLIDE MASTER | 16 June 2016 1 |
Transition to WHO-PQ Vector control product evaluation
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Key PQ activities to achieve transformation have been defined in the recently awarded grant
Improve quality and efficiency of vector control assessment
Assist NRAs to optimize national registration times
Develop a sustainable model for short- to mid-term future of PQT
Prequalify and maintain prequalification status of products
Communicate with stakeholders to build strong trust in WHO prequalification systems
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3
4
5
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Identify and engage NRA contacts and pilot collaborative registration1 procedure
Determine fee structure / funding model for vector control evaluation in PQT
Improve quality and efficiency of vector control assessment
Assist NRAs to optimize national registration times
Develop a sustainable PQT model
Conduct assessments of vector control products in PQT system as of 1/1/17, including quality, safety, and efficacy assessments
Conduct post marketing quality inspections of manufacturing sites and finished products based on risk assessment protocols
Prequalify and maintain prequalification status of vector
control products
Objectives Key activities
Engage with relevant stakeholders to communicate changes in WHO vector control evaluation system, and build strong trust is WHO prequalification systems
Communicate with stakeholders to build strong trust in WHO
prequalification systems
Create and staff vector control assessment group within PQT based on model of other PQT groups and WHOPES
Develop quality assessment systems for vector control products
Overview of the PQT grant
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1. Collaborative procedure with NRAs to facilitate the assessment and accelerated national registration of WHO-prequalified products
TITLE from VIEW and SLIDE MASTER | 16 June 2016 4 |
Transition from NTD (WHOPES) to PQ
TITLE from VIEW and SLIDE MASTER | 16 June 2016 5 |
What is WHO-PQ?
Vision – Good quality medicines for everyone.
Mission – In close cooperation with national regulatory agencies and
partner organizations, the Prequalification Team aims to make quality priority medicines available for the benefit of those in need.
– This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.
http://apps.who.int/prequal/
TITLE from VIEW and SLIDE MASTER | 16 June 2016 6 |
Who is WHO-PQ?
TITLE from VIEW and SLIDE MASTER | 16 June 2016 7 |
Application
New Paradigm
VCAG
Existing Paradigm
New Product Generic
Non-chemical/
Other
Variation
Major Minor Notification
Identifying Necessary Regulatory Pathways
TITLE from VIEW and SLIDE MASTER | 16 June 2016 8 |
Building Regulatory Pathways
KEY PRINCIPLES – Identify the customers – Identify actions and their responsible parties – Develop actions from a “customer benefit” mindset – Strive for the Minimum Viable Pathway (MVP) – Each action is a building block
– ADEQUACY – EFFICIENCY
– FLEXIBILITY
TITLE from VIEW and SLIDE MASTER | 16 June 2016 9 |
General PQ review process
Pre-submission
Applicant is encouraged to communicate any planned
submissions and request pre-sub
meeting(s) to ensure clarity of
dossier requirements and timelines
Screening
PQ conducts a screen of the application to ensure that all
dossier requirements are satisfied
Assessment
Experts are convened to conduct an
assessment of the submitted
application (ASVCP)
Manufacturing facilities are inspected
Listing Decision
PQ Group determines the suitability for
prequalification listing based on the Assessment
session evaluation
Post-PQ
Collaborative Registration with
National Regulatory Authorities
Ongoing inspection of products and manufacturing
facilities to provide quality
control
TITLE from VIEW and SLIDE MASTER | 16 June 2016 10 |
WHO-PQ Vector Control Functions
WHO Action Item
Duration (mos)
WHO Groups Notes/Outcome
Pre-submission Meeting
1 PQ, NTD, GMP
Applicant requests meeting which will be scheduled within ~4 weeks. The desired outcome is that the applicant has a clear understanding of path to submission and dossier requirements.
Protocol Review 4 PQ, NTD, GMP, ASVCP
Applicant may request that PQ conduct a review of proposed protocol for any of the required scientific disciplines. PQ will provide documentation of the review to the applicant.
New Product Review
12 PQ, ASVCP Includes screen, PQ/ASVCP assessment of the dossier and decision for listing.
Generic Product Review
7 PQ, ASVCP Includes screen, PQ/ASVCP assessment of the dossier (including product and AI equivalency determination) and decision for listing.
Variation Review Major
7 PQ Includes label and/or formulation changes which require the review of new data by any part of the science or inspections team
Variation Review Minor
2 PQ Includes label and/or formulation changes which do not require review of new studies or data.
TITLE from VIEW and SLIDE MASTER | 16 June 2016 11 |
Pre-submission Meeting Types
New Product
Variation
New Paradigm
Existing Paradigm
TITLE from VIEW and SLIDE MASTER | 16 June 2016 12 |
Pre-submission Meeting Type
WHO Groups Involved
Outcome
New Product, New Paradigm
PQ NTD GMP
• Determination of Regulatory Pathway, existing or ad hoc
• VCAG review of proposed paradigm • Address questions regarding dossier requirements
specific to the proposed submission New Product, Existing Paradigm
PQ NTD* GMP*
• Determination of Regulatory Pathway • Address questions regarding dossier requirements
specific to the proposed submission
Variation PQ NTD* GMP*
• Determination of Variation track (Minor/Major) • Address questions regarding dossier requirements
specific to the proposed submission
*Included for Utilization Guidance Consultation
Appl
ican
t – N
EW P
RODU
CT
NTD/GMP Data Expectations
Assessment of Efficacy, Safety, and Quality
Development of Recommendation – comparative effect/cost/suitability based
on alternatives
Procurer Consumer
NRA
Join
t Pre
-sub
miss
ion
Mee
ting
for P
rodu
ct D
evel
opm
ent
Guid
ance
Pla
n
Utilization Guidance updated iteratively based on new data, expanded
use and changes in disease pressure
Pre-submission Product Development PQ Assessment/Listing Post-PQ Listing
Large Scale Field Study Submitted
TBD
Appl
icat
ion
PQ Expectations Toxicology Data
Prod. Chem Data
Risk Assessment
Small Scale Field Study
Entomology Data
Post-Market Quality Inspections
Shar
ing
of in
form
atio
n fo
r U
tiliza
tion
Guid
ance
Potential de-listing List
ing
Deci
sion
Draft Label
TITLE from VIEW and SLIDE MASTER | 16 June 2016 14 |
New Product
Appl
ican
t - G
ENER
IC
Utilization Guidance already exists for predicate product
Assessment of Quality and Equivalency to
determine Efficacy and Safety
Procurer Consumer
NRA
Pre-
subm
issio
n M
eetin
g fo
r Pr
oduc
t Dev
elop
men
t Gu
idan
ce P
lan
Pre-submission Product Development PQ Assessment/Listing Post-PQ Listing
Appl
icat
ion
PQ Discussion ?’s
Equivalency?
Data usage concerns for NRA registration?
Predicate Product?
Post-Market Quality Inspections
Efficacy? Potential de-listing Li
stin
g De
cisio
n
TITLE from VIEW and SLIDE MASTER | 16 June 2016 16 |
Generic Product
Appl
ican
t - V
ARIA
TIO
N
NTD/GMP Data Expectations
Assessment of Efficacy, Safety, and Quality as required by proposed
variation
Procurer Consumer
NRA
Join
t Pre
-sub
miss
ion
Mee
ting
for P
rodu
ct D
evel
opm
ent
Guid
ance
Pla
n
Utilization Guidance updated iteratively based on new data, expanded
use and changes in disease pressure
Post-PQ Listing
Pre-submission PQ Variation Assessment Communication of Variation
TBD
Appl
icat
ion
PQ Discussion ?’s
Variation Major?
Data Req’s?
Planned Variation?
Quality Inspections Variation Minor?
Potential de-listing
Deci
sion
Draft Label?
TITLE from VIEW and SLIDE MASTER | 16 June 2016 18 |
Variations
Appl
ican
t – N
EW P
ARAD
IGM
Data Expectations
Join
t Pre
-sub
miss
ion
Mee
ting
for P
rodu
ct D
evel
opm
ent
Guid
ance
Pla
n Pre-submission Product
Development New Product Assessment Post-PQ Listing
TBD
VCAG: NTD-STAG/GMP-
MPAC/PQ
Data Expectations TBD
NEW PRODUCT Pathway
TITLE from VIEW and SLIDE MASTER | 16 June 2016 20 |
Next Steps for PQ Vector Control Staffing
– Group Lead, Case Manager, Entomologist and Inspector – Position postings closed June 2 – Formulation Chemist and Risk Assessor positions to be posted in the fall. – Assemble experts to serve on Assessment Session for Vector Control Products (ASVCP)
Refine pathways – Develop external guidance and internal SOPs – Review data requirements for product and site PQ listing
Develop transition plan with NTD for the transfer of product tracking responsibilities
Inform NRAs on the Collaborative Registration Procedure and find volunteer countries for future pilot
Utilize website to post communication plan regarding upcoming events, guidance, and point of contact references - http://apps.who.int/prequal/vcp.htm
Vector Control mailbox - [email protected]