submission of marketing authorization application …edu.tcfst.org.tw/edm/gsp/speaker/session...

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‐nroll@fda.gov.ph followingtheGUIDELINESONE‐COURSEREGISTRATION.Theapplicantwillreceiveasystemgeneratedreply.

3. VerificationProcess3.1Ifdisapproved,applicantreceivesresponse

indicatingthereasonforthedisapproval.Applicantneedstosubmitanewapplicationform

3.2Ifapproved,applicantreceivesanASSESSMENTFORM

4. PaytheregistrationfeeeitherattheFDACashieroratanyDBPbranches

5. Emailthescannedcopyofthereceipt/proofofpaymenttoe‐nroll@fda.gov.ph5.1Ifsentwithin5days,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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