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WHO Prequalification of Diagnostics, Medicines and Vaccines - 3rd Consultative Stakeholders Meeting. WHO prequalification of vaccines and vaccine delivery devices Drs. Umit Kartoglu and Nora Dellepiane WHO HQ, Geneva- 4 February 2008. 3rd WHO Prequalification Stakeholders Meeting.

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who prequalification of diagnostics medicines and vaccines 3rd consultative stakeholders meeting

WHO Prequalification of Diagnostics, Medicines and Vaccines - 3rd Consultative Stakeholders Meeting

WHO prequalification of vaccines and vaccine delivery devices

Drs. Umit Kartoglu and Nora Dellepiane

WHO HQ, Geneva- 4 February 2008

3rd WHO Prequalification Stakeholders Meeting

vaccines prequalification purpose
Vaccines prequalification- Purpose
  • A service provided to UN purchasing agencies.
  • Provide Independent opinion/ advice on the quality, safety and efficacy of vaccines for purchase
  • Ensure that candidate vaccines are suitable for the target population and meet the needs of the programme
  • Ensure continuing compliance with specifications and established standards of quality

3rd WHO Prequalification Stakeholders Meeting

vaccines prequalification principles
Vaccines prequalification-Principles

GMP

Clinical data

Consistency of final

product characteristics

Meeting WHO requirements

and tender specs

Reliance on NRA

3rd WHO Prequalification Stakeholders Meeting

vaccines prequalification reliance on nra
Vaccines prequalification- Reliance on NRA
  • The responsible National Regulatory Authority (usually that of the producing country) is independent andfunctional:
  • Meets all the critical indicators required for prequalification purposes following a WHO independent assessment
  • The status of the NRA is reassessed at regular intervals

3rd WHO Prequalification Stakeholders Meeting

slide5

UN agency

Direct Procurement

Production

Regulation System

Licensing

AEFI monitoring

Lot release

Access to laboratory

Regulatory inspections

Regulatory functions depending on vaccine source

Vaccine source

Regulatory functions

Functions

assured

by NRA of

producing

country and

WHO PQ system

Fuctions assured

by NRA of

producing

country

Authorization of

clinical trials

vaccines prequalification required regulatory oversight
Vaccines prequalification- Required regulatory oversight

Critical for countries: allows to ensure quality of actual lots received

L

Inspections at regular

Intervals.

Inform WHO of serious

GMP deviations

Lot to lot release

Post-marketing surveillance

for safety and efficacy

Inform WHO in case of reports

of serious AEFI

Regulatory Actions:

Inform WHO in case of withdrawals

or recalls of lots and license

suspensions

3rd WHO Prequalification Stakeholders Meeting

vaccines prequalification evaluation procedure
Vaccines prequalification- Evaluation procedure
  • Review of quality data
  • Review of efficacy and safety data

with focus on data relevant for the target

population in the recommended schedules

  • Production consistency at commercial scale
  • Compliance with GMP
  • Compliance with WHO recommendations
  • Compliance with UN tender specifications
  • Programmatically suitable presentation

3rd WHO Prequalification Stakeholders Meeting

vaccines prequalification impact of the project
Vaccines Prequalification- Impact of the project

Assured Quality

Replacing country's

Regulatory oversight

NRA and

Manufacturer

strengthened

Seal of quality

Requirement for

procurement

3rd WHO Prequalification Stakeholders Meeting

vaccines prequalification features
Vaccines Prequalification- Features
  • Pre- evaluation meetings with mfgs and NRAs
  • 3 deadlines for submissions, joint reviews
  • 12 months evaluation (time taken by manufacturer excluded)
  • Clock stop system
  • Increased portfolio of vaccines
  • Prioritization system defined by UN agencies
  • PQ status valid for 2 to 5 years
  • Information published on WHO website (updated monthly)

3rd WHO Prequalification Stakeholders Meeting

vaccine pq evaluations and reassessments
Vaccine PQ- Evaluations and Reassessments

3rd WHO Prequalification Stakeholders Meeting

vaccines pq addressing the challenges
Vaccines PQ- Addressing the challenges
  • Provision for fast-track procedure in case of emergency vaccines (six months)
  • Addressing seasonal and pre-pandemic influenza vaccines (expedited procedure)
  • Provision for parallel evaluation with NRA for high priority vaccines
  • Increased human resources
  • Guidance documents produced
  • Strengthening quality assurance system
    • SOPs
    • Quality database
    • Testing database
    • Collaboration with EDM and EHT for development of common database for monitoring submissions
vaccines pq the way forward
Vaccines PQ- The way forward
  • Sustainability of the process: risk based approach:

Current procedure

curre

High risk: products from manufacturers with limited/no experience with the PQ process/ the product in question, and/or the NRA is borderline with respect to functionality

Medium risk: manufacturer with or more prequalified vaccines and experience with product in question, or manufacturer is new to the system but supported by a JV with a with a well established mfg and NRA is functional.

Low risk: Manufacturer is well established, more than one product prequalified, and may or may not have experience with product in question but has good research and development infrastructure. NRA is functional.

Lighter procedure*

lighter

* Strict compliance with post-marketing commitments and close FU of functionality of NRA

building on vaccine pq system to expedite maa process in receiving countries
Building on vaccine PQ system to expedite MAA process in receiving countries
  • Countries require that only licensed vaccines be used
  • Manufacturers are asked to submit dossiers and pay fees
  • Licensing timelines may be very long
  • Expertise for review not always available
  • Confidentiality not always guaranteed
  • Use of vaccine in country sometimes delayed pending evaluation

3rd WHO Prequalification Stakeholders Meeting

procedure for expedited approval of prequalified vaccines used in nip
Procedure for expedited approval of prequalified vaccines used in NIP

Intent of the procedure:

  • To comply with national regulations and international standards.
  • To continue to provide timely access to vaccines that meet standards of assured quality.
  • To enable countries to put more emphasis on post marketing surveillance system (AEFI).
  • Focuses on regulatory approval process and does not affect any post-approval activities in place.

3rd WHO Prequalification Stakeholders Meeting

procedure for expedited approval of prequalified vaccines used in nip1
Procedure for Expedited Approval of Prequalified Vaccines used in NIP

Scenario 1: Countries sourcing from UN agencies

For an expedited approval of WHO-prequalified vaccines that are sourced from UN procurement agency.

Scenario 2: Countries procuring directly

For an expedited approval of WHO-prequalified vaccines that are procured directly.

Provides guidance as to how NRAs of these countries

can build on the processes in place for the WHO prequalification

to expedite the granting of regulatory approval for such products

3rd WHO Prequalification Stakeholders Meeting

proposed implementation plan searo 2008
Proposed implementation plan- SEARO 2008
  • Review national regulations, procurement process, vaccine import procedures, and any other processes as required.
  • Adapt and adopt guidelines as part of national regulatory process applied to vaccines for use in NIP.
  • Ensure smooth transition period.
  • Encourage manufacturers to start the process.
  • Receive applications from manufacturers
  • Review applications and notify WHO & the manufacturer (with copy to UN procurement agency if relevant).
  • Add product information to national approved drug list.
  • Encourage other manufacturers and repeat the process until all pre-qualified vaccines (suppliers) receive expedited regulatory approval.

3rd WHO Prequalification Stakeholders Meeting

who website link to pq and expedited approval procedures
WHO website link to PQ and expedited approval procedures

http://www.who.int/immunizationstandards/vaccine_quality/pq_suppliers/en/index.html

3rd WHO Prequalification Stakeholders Meeting

performance quality and safety pqs background the interested parties
Performance, Quality and Safety (PQS)Background- The interested parties
  • WHO: takes the duty to specify and verify cold chain and other products for immunization.
  • UN procurement agencies: are products fit for purpose?
  • Client countries:what’s the performance of the product, and where should it be used?
  • Industry:a fair basis for tendering and investing in development.

3rd WHO Prequalification Stakeholders Meeting

pqs background product information sheets pis
PQS Background- Product Information Sheets (PIS)

-Collaboration between UNICEF

Supply Division and WHO

-Performance specifications and

test procedures for

immunization-related products,

including cold chain equipment.

- Main information for buyers of

products used in NIP

- Conform products listed

- Last PIS eddition 2000

3rd WHO Prequalification Stakeholders Meeting

pqs product categories
PQS- Product categories
  • E01 > Cold rooms, freezer rooms and related equipment.
  • E02 > Transport (guidance only – includes refrigerated vehicles)
  • E03 > Refrigerators and freezers, including solar (PV) systems.
  • E04 and E11 > Cold boxes, vaccine carriers and biological specimen carriers.
  • E05 > Ice packs
  • E06 > Temperature monitoring devices.
  • E08 and E13 > Single-use injection devices (AD syringes for immunization and curative services).
  • E10 > Waste management equipment.

3rd WHO Prequalification Stakeholders Meeting

pqs procedures
PQS- Procedures
  • PQS works on a cost-recovery basis.
  • SOPs that detail the procedure

(writing/amending specs, product review and disqualification, test laboratory accreditation)

  • Product evaluation: Compliance with an ISO standard.
  • All pre-qualified products subject to annual review.
  • All product data sheets and guidelines web-based.

http://www.who.int/immunization_standards/vaccine_quality/pqs/en/index.html

3rd WHO Prequalification Stakeholders Meeting