submission of marketing authorization application …edu.tcfst.org.tw/edm/gsp/speaker/session...
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RepublicofthePhilippinesDepartmentofHealth
FoodandDrugAdministration
SUBMISSIONOFMARKETINGAUTHORIZATIONAPPLICATIONFORPHARMACEUTICALPRODUCT:THEPHILIPPINEEXPERIENCE
ESTRELLITAB.PASTOLEROOfficer‐In‐Charge
PublicAssistance,InformationandReceiving(PAIR)UnitFoodandDrugAdministration
A. OverviewoftheFoodandDrugAdministration
B. FilingandReceivingofApplicationsC. QualifiedPersoninRegulatoryAffairs
(QPIRA)
PresentationOutline
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RepublicofthePhilippinesDepartmentofHealth
FoodandDrugAdministration
A.OverviewofFDA
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RepublicAct9711
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OrganizationalStructure
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• Regulatethemanufacture,importation,exportation,distribution,sale,offerforsale,transfer,promotion,advertisement,sponsorshipof,and/or,whereapplicable,theuseandtestingofhealthproducts;
• ToevaluateandissueappropriateauthorizationsforallhealthproductsandhealthproductestablishmentsregulatedbytheCenter
Center forDrugRegulationandResearch
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CDRRManpowerComplement
Total CDRRpersonnel
TechnicalPersonnel
NontechnicalPersonnel
78 54OIC:3
Licensing:7Registration:27
PRSDD:8PV:6CTU:3
24OIC:1
Licensing:7Registration:4PRSDD:1PV:1CTU:1
DataMgmt:8Aux:1
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CY2014 CY2015*
Initial 2727 Initial 1333
Renewal 3456 Renewal 2142
Variation 5714 Variation 4488
CDRRApplicationsReceived
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*January‐August2015
RepublicofthePhilippinesDepartmentofHealth
FoodandDrugAdministration
B.FilingandReceivingofApplications
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FDAwebsite(www.fda.gov.ph)
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FDAwebsite
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DrugRegistrationRequirements
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DrugRegistrationRequirements
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ApplicationProcessGuide
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AutomatedPAIRDocumentReceivingAssistant(APDRA)
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•
AutomatedPAIRDocumentReceivingAssistant(APDRA)
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TrackingofApplication
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RepublicofthePhilippinesDepartmentofHealth
FoodandDrugAdministration
C.QPIRATrainingandAccreditation
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QPIRACoursesCalendar
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CourseRegistrationForm
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ProcessofApplication
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1. Downloadandfill‐outtheCOURSEREGISTRATIONFORMattheFDAwebsite(www.fda.gov.ph)
2. Emailtoe‐[email protected] followingtheGUIDELINESONE‐COURSEREGISTRATION.Theapplicantwillreceiveasystemgeneratedreply.
3. VerificationProcess3.1Ifdisapproved,applicantreceivesresponse
indicatingthereasonforthedisapproval.Applicantneedstosubmitanewapplicationform
3.2Ifapproved,applicantreceivesanASSESSMENTFORM
4. PaytheregistrationfeeeitherattheFDACashieroratanyDBPbranches
5. Emailthescannedcopyofthereceipt/proofofpaymenttoe‐[email protected],applicantreceivesasystem‐
generatedCONFIRMATIONSLIP5.2Ifnotsentwithin5days,applicantmaybe
rescheduledonthenextavailableschedule/date6. BringtheCONFIRMATIONSLIPonthedayofthe
TrainingWorkshop
TIME ACTIVITY FACILITATOR/SPEAKER7:30–8:30am Registration FDAAcademy8:31‐ 8:35am Opening Ceremony
Prayer National Anthem
8:36‐ 9:00am PreliminaryAssessment/AMSnack9:01–9:30am Opening Remarks Melody M. Zamudio, RPh, MGM‐ESP
OIC, CDRR
CDRR Updates and Overview of ACTD Juan Paolo M. TonoleteHPO II, Product Research StandardDevelopment Division (PRSDD)
Module1:CDRRProcess9:30–10:45am Session 1: Process of Filing an Application
and Releasing*Follow‐up Process
Estrellita B. PastoleroOIC, Public Assistance Informationand Receiving Unit (PAIR)
Module2:AdministrativeRequirements10:46‐11:00am Session 1: Certifications Jeannerey Arien G. Macabebe
Pharmacist II, PRSDD11:01‐11:45am Session 2: Labeling
12:01‐1:00pm LunchBreakModule3:Quality
1:01‐1:45pm Session 1: API and FPP Assessment Willison John E. De LunaFDRO III, Licensing and RegistrationDivision (LRD)
2:01‐2:45pm Session 2: ACTRs: Stability Study Khristie MichelleD.VenturaFDROII,PRSDD
3:01‐3:15pm Break3:16‐4:15pm Session3:ACTRs:ProductInterchangeability
(BioequivalenceStudies)Willison John E. De LunaFDRO III, LRD
4:26‐4:30pm Summary
QPIRATraining Program‐ Drugs
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Day1
TIME ACTIVITY FACILITATOR/SPEAKER7:45–8:30am Registration FDAAcademy
Module3:Quality (Continuation)8:31:9:25 Session4:ACTRs:
AnalyticalMethodValidationRochelleR.delMundoFDROIII,PRSDD
9:36–9:45am Break9:46‐10:30 Session5:ACTRs:
ManufacturingProcessValidationRichard Simon R. BinosFDRO III, PRSDD
10:46‐11:45am Session 6: ACTRs:ASEAN Variation Guidelines
Mary Joie R. JardineroFDRO II, LRD
12:01‐1:00pm LunchBreakModule4:SafetyandEfficacy
1:01‐1:30pm Session 1: PSUR and PMS Juan Paolo M. TonoleteHPO II, PRSDD1:31‐2:00 Session 2: Advertising and
Promotions2:16‐2:30pm Break2:31‐3:00pm Session 3: Counterfeit Monitoring Jeannerey Arien G. Macabebe
Pharmacist II, PRSDD3:16‐3:45pm Session 4: Product Recall Kayla Veron G. Catolico
Pharmacist II, PRSDD4:01‐4:30pm PostAssessment,SummativeEvaluationandSummary4:31‐5:00pm ClosingRemarks ATTY. RONALD R. DE VEYRA
OIC, Deputy Director GeneralAdministrationandFinanceOffice
QPIRATrainingProgram– Drugs
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Day2
QPIRACertificateandID
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