23. Prof. Shynar Baidullayeva - National Center for Medicines, Medical Devices and Medical Equipment Expertise (Republic of Kazakhstan)


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“Pharmacovigilance in the Republic of Kazakhstan -Peculiarities. Biological medicinal products safety monitoring”

Shows the current pharmacovigilance system and practices in Kazakhstan, with a focus on biotherapeutic medicines

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  • 06/20/13
  • 06/20/13
  • 06/20/13
  • 23. Prof. Shynar Baidullayeva - National Center for Medicines, Medical Devices and Medical Equipment Expertise (Republic of Kazakhstan)

    1. 1. Pharmacovigilance in the Republic of KazakhstanPeculiarities Biological medicinal products safety monitoringThe National Center for Drug Expertise, Medical items and EquipmentMinistry of Public HealthRepublic of KazakhstanSh. BaidullayevaHead of Department for Pharmacological Assessment15-16 мая 2013, МоскваБиотерапевтические препараты. Современные вызовы и регуляторные практики. Подходы кгармонизации.
    2. 2. Kazakhstan Pharmacovigilancelegislationthe Kazakhstan Health Code (18.09.2009)the MoH Orders under №735 (18.11.2009)the MoH Orders under №647 (03.11.2009)“Relating to the ADRs monitoring”
    3. 3. 3MPhACC*Department forPharmacologicalassessmentADRs monitoring groupMinistry of HealthcareNational Centre forDrug expertiseThe structure of Pharmacovigilance in Kazakhstan*MPhACC - the Medical and Pharmaceutical activitycontrol Committee
    4. 4. MPhACC’s** as a regulatorybody Kazakhstan Ministry ofPublic healthMPhACC’s** as a regulatorybody Kazakhstan Ministry ofPublic healthThe National Center for DrugExpertise, Medical items andEquipment’s on expert body inmedicinal products regulationLocal ADRs reports, CIOMS reports,PSURs, pharmacovigilance data fromother countriesMinistryofPublicHealthPharmacovigilancedata assessment tomakerecommendations fortaking regulatorymeasuresRegulatory measures to SuspendMA, Withdraw MA or Variationsfor MA based on recommendationNCDE**NCDE - The National center for drug expertise, medicalitems and equipment**MPhACC - the Medical and Pharmaceutical activitycontrol CommitteeThe structure of Pharmacovigilance inKazakhstan
    5. 5. 5Medical workersMedical workersPharmaceuticalPharmaceuticalworkersworkersCustomersCustomersTerritorial branches ofTerritorial branches ofMPhACC and NCDEand NCDE,,Departments of PublicDepartments of PublicHealth servicesHealth servicesMPhACCMPhACCNCDENCDEGranting theinformationInformationcollectionInformation analysisand decision-makingInformationaccumulationInformationDistributionInformationaboutadverseeffectsInforming system of drug adverse reactionsWEB -SITEWEB -SITECDCDData baseData basePrintingPrintingpublicationspublicationsPharmaceuticalPharmaceuticalmanufacturersmanufacturersNCDENCDEADRs monitoring groupADRs monitoring groupUppsala WHOUppsala WHOVigiFlowVigiFlow
    6. 6. • “Yellow card-message” is the maininstrument to monitor ADRs• In case of any ADRs or the lack of effectthe medical professionals, pharmaceuticalcompanies, patients and pharmacists willfill in this card-message6
    7. 7. 7
    8. 8. • It is required to report to the NCDE on emergencybasis on all suspected serious anticipated andunexpected ADRs within 24 hours• The reporting term for non-serious ADRs is 15calendar days, or they can be included into nextPSUR.Reporting termsOrder of the ADRs monitoring rules
    9. 9. • The MAHneeds to report CIOMS Iconcerning serious ADRs that havebeen detected outside Kazakhstanand which have not been listed inSmPC oranothercompany Core DataSafetyCIOMS IOrder of the ADRS monitoring rules
    10. 10. 10Terms for PSUR submitting• For new registered products PSUR will besubmitted every 6 months over the first 2years and once a year over 3 years• For reregistered products PSUR will besubmitted over re-registration processever 5 yearsOrder of the ADRS monitoring rules
    11. 11. PSURs form in Kazakhstan• has been approved for execution on theterritory of Kazakhstan by the StatePharmaceutical Control Committee Order№170/2008Order of the ADRS monitoring rules
    12. 12. RISK MANAGEMENT PLAN1) Applying for marketing authorization: New active substance medicinal product; Biosimilar, and also biological product manufacturing variation; Original medicinal product’s new form, administration, indicationextending, including variations for indication in pediatry and majorchanges for indications ; Generic product with additional risk minimization measures in caseinformation about risks related to original product;2) At MPhACC or NSDE’s requests during or after registrationprocedure
    13. 13. ADRs monitoring over 2005 to 2012: total 3938 reports
    14. 14. Name Year DecisionPolyvinylpyrrolidone with a molecular weight of 12600 2007 BannedGatifloxacin 2009 BannedBoric acid and its derivatives (eye / ear drops, solutionfor external use)2009 Restricted: not more than 3%Nimesulid 2009 Contraindicated in patients younger than 18 yearsCould and cough fixed combination formulationscontaining paracetamol with pseudoephedrine,caffeine, dextromethorphanС 2010 Contraindicated for children up to 12Could and cough fixed combination formulationscontaining paracetamol with ephedrine, codeineС 2010 Contraindicated for children up to 14Paracetamol more than 500 mg in single dosage С 2010 No longer registration/re-registrationCombinations of two or more NSAID С 2010 No longer registration/re-registrationPancreatin combination with other enzymes, bovinebileС 2010 No longer registration/re-registrationMetamizol combinations С 2010 No longer registration/re-registrationPioglitazone 2011 SuspendedSibutramin 2011 BannedRasilez 2012 SuspendedTredaptive 2013 Under withdrawingCalcitonin 2013 Under withdrawingKazakhstan regulatory measures
    15. 15. Biological medicinal product ADRs monitoring (by ATC Code)
    16. 16. Biological medicinal product ADRs monitoring(by WHO-ART)
    17. 17. Risk management plan• Implementation started from 2012 for the following productsName CompanyLusentis (ranibizumab) Novartis PharmaEnpleyt (romiplostim) Pateon SpA ItalySebivo (Telbivudine) Novartis PharmaTasigna (Nilotinib) Novartis PharmaStelara ® (ustekinumab) Cilag AG
    18. 18. ADRs monitoring improvement measures• 1. Joined plan with the Public health service departments and MPhACC’sbranch-departments in 14 regions• 2. Working group on proposal development in Pharmacovigilancelegislation: NCDE, pharmaceutical companies• 3. Collaboration with the Drug information center, Scientific-researchInstitutes• 4. Postmarketing studies: non-interventions, safety studies• 5. Implementation of Risk management plan
    19. 19. http://www.dari.kz
    20. 20. Thank you for attention!