04 The role of NRA in technology transfer ver 3 · 2| Topics Vaccine development and NRA role NRA...
Transcript of 04 The role of NRA in technology transfer ver 3 · 2| Topics Vaccine development and NRA role NRA...
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
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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