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Linking Regulatory Decisions and PublicHealth Decisions for Vaccines:
the Indonesian Experience
Lucky S. SlametNational Agency of Drug and Food Control (NADFC),Rep.of Indonesia
Workshop D “Vaccines and Biological”14th International Conference of Drug Regulatory Authorities (ICDRA)
Singapore, 30 November 2010
Key Points
IntroductionMandate of NADFC as NRA in Indonesia with regards to Pre-Post Market of VaccinesNational Indonesian Technical Advisory Group (NITAG) mandate Model of Interaction among NITAG, NADFC as NRA and CDC - MOHCase studyConclusion
Introduction REGULATORY CHALLENGES ON AVAILABILITY OF
VACCINES IN INDONESIA
Demand for greater access to new vaccines which are affordable to support the Indonesian Immunization Program as to reduce mortality and morbidity caused by communicable diseases
Ensuring vaccine of assured safety, efficacy and quality as well as appropriateness of its use based on the real need of majority of population.
Ensuring consistency in Pre to Post Market Risk Assessment of vaccines by implementation of Good Regulatory Practices from development, production, importation, exportation and distribution to end-user (patient/consumer).
Mandate of NADFC as NRA in Indonesiawith regards to Pre-Post Market Control of
Vaccines
5
law enforcement with a high deterrent effect
Investigation and pro-justicia
Good Laboratory Practice (GLP)
Good Clinical Practice (GCP)
GDRP
Comprehensive Audit
Good Manufacturing Practices
(cGMP)
Specification and quality of substance, product, packaging (Pharmacopeia and non-compendial)
Good Manufacturing Practices (cGMP)
Good Distribution Practice(GDP)
Good Sampling Practice(GSmP)
Good Laboratory Practice(GLP)
Inspection
FUNCTION OF NADFC BASED ON 3 MAIN PILLARS OF GOOD DRUG REGULATORY PRACTICES (GDRP)
The Role of NADFC-Indonesia at Different Stages of Vaccine Development, Production and Evaluation
Research and Development of vaccines
Research and Development of vaccines
National regulatory systemClinical trial approvalReview of dossier/ Site Master File (SMF) as a part of MA procedureLot releaseLaboratory AccessSurveillance of vaccine field performance (AEFI)Regular inspections for GMP
The role of NRA in Vaccine Seven Regulatory Functions
Production and control of vaccines
Production and control of vaccines
Clinical trials Clinical trials
Licensing/Marketing Author Licensing/Marketing Author
Post marketing surveillance Post marketing surveillance
Preclinical testing Preclinical testing
7
Vaccine Regulatory PathwaysPre-Post Market
Registration-Pre Marketing Post Marketing
Product evaluation
Marketing Authorization
AEFIsLot release
GMP inspections
Market distribution
Lab.access
Lab.access
GMP inspections
Dossier
Overall Regulatory Frameworkin Vaccine Development, Production
and Evaluation in INDONESIA
Vaccine of Assured Q,S,E
Manufacturer
Pre- IND
Manufacturing process
development(batch trial)
Preclinical trial
IND
IND Regulatory
process
Regulatory consultation
GMPPhase 1
Safety
Immuno-genicity
Phase 2
Immuno-genicity
Safety
Dose ranging
Phase 3
Efficacy
Safety
Immuno-genicity
InspectionLot release
Pre-market Evaluation
MA Granted
PreRegistration
Preliminary review of full dossier
Process of Registration
Production
GMP
GMP
PMS / AEFI Monitoring
Communication with Sponsor / Manufacturer
during CTGCP
Inspection
• Global concern• Regional related data• Local data: incidence, prevalence, death rate, age
vulnerable group, sequelae Burden of disease
• Guideline : SAGE & WHO position paper • Pilot project • TAG’s recommendation
Guideline Recommendation
• Release/ registered to NRA• Cost benefit analysis • Vaccine sustainability
Vaccine availability
• MOH policy • Socialization /training• Operational cost GOI & local government• AEFI surveillance
Planning
New Vaccine Introduction into EPI Program in Indonesia
by NRA, CDC-MOH and NITAG
The National Indonesian Technical Advisory Group on Immunization (NITAG) mandate
to advise the national government on the formulation of strategies for the control of
vaccine preventable diseases through immunization
to guide national government on issue of vaccine quality and safety, immunization
choices and strategies, new vaccines and new delivery technologies
to assist the national authorities in evidence-based decision making
Mandate of NITAGA technical independent advisory group
MOH Decree, December 15th 2006 No.1418/Menkes/SK/XII/2006,revised in 2008&2010
To provide on immunization schedules, public & private sector
Review articles & recommendation on new vaccines
Standardize of AEFI reporting through the AEFI National Committee
Provide technical advise to help the government make decisions on immunization issues
The Role of NITAG
Sub committees of NITAG(Working group)
HepatitisMeaslesPolio eradicationAEFI National Committee
InfluenzaRotavirusPneumococcusHPV
Member of Working Group is also member of Regional CommitteeAPACHI, ASAP, ARSN, & other regional vaccine advisory
committee
Model of Interaction among NITAG, NADFC as NRA and CDC - MOH
CDC - MOH
NITAGNRA
CDC MOH ‐ TAG ‐ NRA Interaction
Decree of Ministry of Health
Liaison members
Recommendation*Immunization schedules,*AEFI reporting*Technical advised fordecisions on immunization issues
*Pre‐market evaluation on clinical data of new vaccines* Introduction & evaluation of new vaccines*AEFI reporting
NADFC as NRA
NRA seeks scientific advice from NITAG’s with regards to• Decision making for vaccine’s Marketing Authorization• IND process for new vaccine• Post marketing surveillance
Involvement in NITAG’s meetings or discussions for developing guidance and scientific opinions
NRA advise on Marketing Authorization process and approval for vaccines used as EPI program
NADFC’s Role in the Networking of NRA – NITAG – CDC-MOH
Involvement in the stage of IND (investigational new drug/vaccine): • Evaluation of CT protocol• Advise for immunization schedule for CT and target population
Pre-market evaluation on clinical data of new vaccines
Introduction & evaluation of new vaccines
AEFI reporting
NITAG’s Role in the Networking of NRA – NITAG – CDC-MOH
Example of Case Study(Model of Interaction among NITAG,NADFC as NRA and CDC-MOH)
Replacement Tetanus Toxoid (TT) to Tetanus Diphteriae (adult type,Td) vaccination into School Children Immunisation Program
Year Diphteria Outbreak TotalcasesCases Freq Death CFR (&)
2003 5 5 - -2004 15 13 4 26.72005 52 42 4 7.7 13002006 44 38 4 9.1 1622007 86 66 6 6.9 1832008 77 73 11 14.3 2182009 140 135 8 5.7 121
Age(years)
Percent(%)
< I 41-4 315-9 36
10-14 16>14 13
6
5 25 140
1
77 (27 cases, 50 carriers)
6
64 2
Diph
teria
Out
brea
k20
03-2
009
20092010
Data : Sub-Directorate Surveilance, CDC, 2010
Age (years)
N Seroprotection(%)
> 1 1564 801-4 281 705-9 551 75
10-14 584 80
Data: National Institute Health Research Development, MOH, 2007
Protective titer of anti diphteria antibody ≥ 0,1 IU/ml
Year Coverage (%)2005 83.12006 90.62007 90.6*2008 93.52009 95.4
*Basic Health Research 2007 : 67.7%
DTP3 immunization coverage• High coverage of DTP-3• Not spread equally in all areas• No booster at 18-24 months
Seroprotection• 20%-30% children below 14
years of age did not reach protective level
CDCProblem:Diphteria
outbreak
NITAG*Review data
*Vaccine production capacity (BF)
NITAG Recommendation• Td use in school children• Outbreak response strategies
Bio Farma• Increase production
capacity of Td vaccine• Vaccine registration to
NRA
NRATd vaccine registration for
National Programme
Letter to NITAG
August 2008
November 2008
Registration November 2008
Registration Approval November 2009
Ask the capacity of vaccine production
Update
RecommendationApril 2010
Introduction of Td Vaccine in theNational Immunization Program
Lot Release & Lab Access
System on MA
CO
NT
RO
L B
Y N
AD
FC
IND
ON
ESI
A
Component ofNRA Function
CONCLUSION Linking Regulatory Decisions & Public Health Decisions for Vaccines
Clinical Trial
Monitoring PMS incl AEFI
Regulatory Inspection
VACCINE of assured
QUALITY, SAFETY &
EFFICACY, andaccording to the
actual need of the population
Model of Interaction among NITAG, NADFC as NRA & CDC- MOH
Borobudur-Budha’s Temple-Central Java Prambanan-Hindu’s Temple-Central Java
VISIT INDONESIA
Bali
Mt. Bromo-East Java
Bunaken –North
Sulawesi
Thank You