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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 Biological14th 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

    lawenforcementwithahighdeterrenteffect

    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 TAGs 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

    NewVaccineIntroductionintoEPIProgram inIndonesia

    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

    CDCMOH TAG NRAInteraction

    DecreeofMinistryofHealth

    Liaisonmembers

    Recommendation*Immunizationschedules,*AEFIreporting*Technicaladvisedfordecisionsonimmunization issues

    *Premarketevaluationonclinicaldataofnewvaccines*Introduction&evaluationofnewvaccines*AEFIreporting

    NADFC as NRA

  • NRA seeks scientific advice from NITAGs with regards to Decision making for vaccines Marketing Authorization IND process for new vaccine Post marketing surveillance

    Involvement in NITAGs meetings or discussions for developing guidance and scientific opinions

    NRA advise on Marketing Authorization process and approval for vaccines used as EPI program

    NADFCs 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

    NITAGs 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-Budhas Temple-Central Java Prambanan-Hindus Temple-Central Java

    VISIT INDONESIA

    Bali

    Mt. Bromo-East Java

    Bunaken North

    Sulawesi

    Thank You