transition to who-pq · 9 | title from view and slide master | 16 june 2016 general pq review...

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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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


Transition from NTD (WHOPES) to PQ


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/


Who is WHO-PQ?


Application

New Paradigm

VCAG

Existing Paradigm

New Product Generic

Non-chemical/

Other

Variation

Major Minor Notification

Identifying Necessary Regulatory Pathways


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


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


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.


Pre-submission Meeting Types

New Product

Variation

New Paradigm

Existing Paradigm


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


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


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?


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


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]

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

mailto:[email protected]

transition to who-pq · 9 | title from view and slide master | 16 june 2016 general pq review...

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