The role of National Regulatory

Authorities in technology transfer

The role of National Regulatory

Authorities in technology transfer

A. A. Khadem

B. FCH/IVB/QSS

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TopicsTopics

� Vaccine development and NRA role

� NRA functions according to source of vaccine

� Vaccine regulatory process

� WHO prequalification principals

� WHO NRA strengthening, 5 step capacity building

� Tentative roadmap for NRA strengthening

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Vaccine Development and NRA roleVaccine Development and NRA role

Product development

Product development

LicensingLicensing

Characterization of

candidate vaccine

Characterization of

candidate vaccine

Preclinical/Nonclinicaltesting

Preclinical/Nonclinicaltesting

Clinical trials

Clinical trials

PMSPMS

Manufacturer/Developer

National Regulatory Authority

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Source of vaccines

UN agencyUN agency ProcureProcure ProduceProduce

FunctionsUndertakenby WHO onBehalf of

UN agencies or producingcountries

FunctionsUndertakenby WHO onBehalf of

UN agencies or producingcountries

Functionsundertaken

By theproducing country

Functionsundertaken

By theproducing country

National Regulatory Functions

depend on vaccine source

Marketing Autorization & Licensing activities

Laboratory access

Regulatory inspections

Lot release

Authorization & monitoring of CTs

Postmarketing: AEFI

Regulatory system

Regulatory functions

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Regulatory functions

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Clinical trials (Ethical review process, GLP,GMP,GCP)

Clinical trials (Ethical review process, GLP,GMP,GCP)

Pre-marketing phasePre-marketing phase Post Marketing phasePost Marketing phase

AEFIsurveillance

AEFIsurveillance

Lot releaseLot release

Regulatoryinspections

Regulatoryinspections

Market distribution

QualityQuality

SafetySafety

EfficacyEfficacy

ProductEvaluation

ProductEvaluation

GMP

compliance

GMP

compliance

Licensingfacility

Licensingfacility

Laboratory testing

Laboratory testing

DossierDossier

Licensing/Registration= evaluation process

Applicants

Dossier(manufacturer or

distributor)

Applicants

Dossier(manufacturer or

distributor)

Marketing Authorization (M.A.)Marketing Authorization (M.A.)

Vaccine regulatory processVaccine regulatory process

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Supervision of clinical trialsSupervision of clinical trials

Vaccine regulatory processVaccine regulatory process

Pre-marketing phasePre-marketing phase Post Marketing phasePost Marketing phase

AEFIsAEFIsLot releaseLot release

GMP inspections

GMP inspections

GMP

assessment

GMP

assessment

Applicants

Dossier

Applicants

Dossier

Clinical EvaluationClinical Evaluation

Product

evaluation

Product

evaluationQuality Control Quality Control

Function 1Marketing Autorization &

Activities licensing

Function 3Lot release

Function 4Laboratory

access

Function 2Postmarketing

AEFI

Function 5Regulatoryinspections

Function 6:Supervision of clinical trials

Marketing Authorization (M.A.)Marketing Authorization (M.A.)

Applicants

Dossier

Applicants

Dossier

Supervision of clinical trialsSupervision of clinical trials

Pre-marketing phasePre-marketing phase Post Marketing phasePost Marketing phase

AEFIsAEFIsLot releaseLot release

GMP

inspections

GMP

inspections

GMP assessment

GMP assessment

Clinical EvaluationClinical Evaluation

Product

evaluation

Product

evaluation Quality Control Quality Control

Function 1Marketing Autorization &

Activities licensing

Function 3Lot release

Function 4Laboratory

access

Function 2Postmarketing

AEFI

Function 5Regulatoryinspections

Function 6:Supervision of clinical trials

Marketing Authorization (M.A.)Marketing Authorization (M.A.)

Pre QualificationPre Qualification

Vaccine regulatory processVaccine regulatory process

Product

evaluation

Product

evaluationPre-

qualification

Approved

Pre-

qualification

Approved

UN Tender/

Decision to buy

UN Tender/

Decision to buyGMP

inspections

GMP inspections

NRA assessment

NRA assessment

WHO/HQ WHO/HQ

No

rm

al P

ro

cess

No

rm

al P

ro

cess

UN

ag

en

cie

sU

N a

gen

cie

s

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PQ PRINCIPLESPQ PRINCIPLES

Reliance on functional NRA in the country of manufacture

General understanding of production and control to ensure compliance with WHO

recommendations and UN tender specifications

Insurance of consistency of final Product characteristics (GMP

and testing)

AAAAppropriate for target populationAnd needs of the programme

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Possible scenarios for Technology Transfer

regarding NRA status

Possible scenarios for Technology Transfer

regarding NRA status

Fully functional NRA

NRA is not functional

1

2

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WHO NRA strengthening activitiesWHO NRA strengthening activities

5 steps capacity building

111 222 333 444 555

Ou

tpu

tF

ull

y f

un

cti

on

al N

RA

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Co

nsis

tent P

roductio

n

Step 1

Step 2

Step 3

Step n

NRA capacity building

Targ

et: P

requa

lified v

accin

eFully functionalNRA

Prequalificationprocess

Time NR

A a

ssessm

ent

Tentative roadmap for NRA strengthening

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The boundaries and names shown and the designations used on this map do not imply

the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or

concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

NRA assessment completed

NRA assessment conducted

& planned

Not yet conducted

Country Status: 103 assessment of vaccine

regulatory systems conducted, 1997-2010

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STRENGTHENING NATIONAL REGULATORY AUTHORITIES (NRA)NRA STATUS AS OF 2010 :

59 countries have a functional NRA to regulate vaccines

The boundaries and names shown and the designations used on this map do not imply

the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or

concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

NRA functional

NRA not functional or no data available

Countries where AEFI system have documented progress or and is functionnal

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What can be the role of NRAs in

Technology transfer

What can be the role of NRAs in

Technology transfer

�THANK YOU