Preparation of Documents For New Drug Application And Export Registration.pdf

The New Drug Application is an application submitted to FDA for permission to market a new drug.
To obtain this permission a company submits preclinical and clinical test data to FDA for analyzing the drug information, description of manufacturing procedures.
The Investigational New Drug Application is an application submitted to FDA to obtain permission to begin clinical trails of a new drug in humans.
The IND application includes data on the drug’s composition, manufacturing, and preclinical studies, as well as the proposed clinical trial protocols.

1. DEPARTMENT OF PHARMACEUTICAL SCIENCES,
DR.HARISINGH GOUR VISHWAVIDHYALAYA
(A CENTRAL UNIVERSITY)
SAGAR (M.P) 470003
Presented By:
Amit PratapSingh
Preparation of Documents For New Drug Application
And Export Registration

2. NEW DRUG APPLICATION
TheNewDrugApplicationisanapplicationsubmittedtoFDAforpermissiontomarketa
newdrug.
ToobtainthispermissionacompanysubmitspreclinicalandclinicaltestdatatoFDAfor
analyzingthedruginformation,descriptionofmanufacturingprocedures.
GoverningAuthoritieslike:
A).FoodandDrugAdministration(FDA)–U.S
B).CentralDrugsStandardControlOrganization(CDSCO)-INDIA
C).MedicinesandHealthcareproductsRegulatoryAgency(MHRA)-U.K
D).PharmaceuticalsandMedicalDevicesAgency(PMDA)-JAPAN

3. Thedrugissafeandeffective
initsproposeduse
Theproposedlabellingis
appropriate,andwhatshouldit
contain.
Thedrug’smanufacturing
processisadequatetoensure
itsquality,strength,andpurity.
GOALS OF NDA

4. ThedocumentationrequiredinanNDAissupposedtotellthedrug’swholestory,
including:
Whathappenedduringtheclinicaltests,
Whattheingredientsofthedrugformulationare,
Theresultsoftheanimalstudies,
Howthedrugbehavesinthebody,and
Howitismanufactured,processedandpackaged.
OnceapprovalofanNDAisobtained,thenewdrugcanbelegallymarketed.
DOCUMENTATION REQUIRED IN AN NDA

5. Form FDA-356h. Application to market a new drug, biological or an
antibiotic drug for human use.
Form FDA 3397. User fee cover sheet
Form FDA 3331. New drug application field report.
Required specification for FDAs, IND, and ANDA drug master file
binders.
Impurity in drug substances
Refusal to file.
NDA FORM

6. WHEN TO GO FOR NDA

7. PHASES OF CLINICAL TRIAL

8. PRECLINICAL STUDIES

9. INDA SUBMISSION
The Investigational New Drug Application is an application submitted to FDA to
obtain permission to begin clinical trails of a new drug in humans.
The IND application includes data on the drug’s composition, manufacturing, and
preclinical studies, as well as the proposed clinical trial protocols.

10. PHASE 1 CLINICAL TRIALS
•Phase1trailsarethefirststageoftestinginhuman
subjects.
•ConductonsmallnumberofhealthyHumanVolunteers
(20to100).
•Phase1mainlydeterminetheSafetyandtoxicityofdrug.
•Duration–6to12months
•About70%ofexperimentaldrugspassthisphaseof
testing.

11. PHASE 2 CLINICAL TRIALS
•Conductonpatients
•Determinetheefficacyandtherapeuticeffect
ofdrug.
•Alsodeterminesthesafetyandtoxicity.
•100to1000patientsarethere
•Duration-6monthstoseveralyears

12. PHASE 3 CLINICAL TRIALS
•Involvetestinginseveralhundredtoseveral
thousandpatients.
•Itisalsocalledtherapeuticevolutionary
phase.
•70%to90%ofdrugsthatenterPhaseIII
studiessuccessfullycompletethisphaseof
testing.
•OncePhaseIIIiscomplete,apharmaceutical
companycanrequestFDAapprovalfor
marketingthedrug.

13. PHASE 4 CLINICAL TRIALS
•AlsocalledPostMarketingSurveillanceTrials,areconductedafteradrughasbeenapprovedfor
consumersale.
•Recollectthedrugsampleaftersometimeandagainperformclinicaltrialstofindoutthesafety
andtoxicityofthedrug,
•Pharmaceuticalcompanieshaveseveralobjectivesatthisstage:
1.tocompareadrugwithotherdrugsalreadyinthemarket.
2.tomonitoradrug'slong-termeffectivenessandimpactonapatient'squalityoflife.
3.todeterminethecost-effectivenessofadrugtherapyrelatedtoothertraditionalandnew
therapies.

14. DOCUMENTS FOR REGISTRATION
1.LegalDocuments
A.Form40-Itshouldbesignedandstampedbyindianagent.
B.Powerofattorney-POAShouldbeverifyandaffilatedbyindianambessyandshouldbeco-jointlyseal
signedbyboththepartiesi.e.ManufacturerandindianagentandthensubmittotheCDSCO.
C.ScheduleDIandDII–Theyshouldbesignedandstampedbymanufacturer.
2.TechnicalDocument
A.PlantMasterfile
•Sketchofplantprofile
•CompanyOrganogram(MembersandBoard)
•CompanyPlant
•Machinery
•Hygienic and sanitary measure details
•Heating, ventilation and air condition system
•Men material movement

15. B. Drug Master File
•Manufacturing Process/Flow Chart
•Quality Assurance procedures
•The provision to control contamination
and cross contamination in the final product
C. Labels and inserts
•Product labels should show the address of manufacturer.
•Product inserts should describe the brief description of the product and intenteduse.
•Container closure system
•Stability data
•Biocompatibility data and toxicology data
•Clinical Study report
3. Regulatory Documents
•Notarized Plant registration certificate
•Notarized Manufacturing and Marketing License
•Notarized Free Sale Certificate
•Notarized GMP Certificate

16. PROCESSING OF NDA
•WhenanNDAissubmitted,FDAhas60daystodecidewhethertofileitforrevieworrejectit
ifsomeinformationismissing
•IftheFDAfindstheNDAinsufficientlycomplete,thentheFDArejectstheapplicationby
sendingtheapplicantaRefusetoFileletter,whichexplainswheretheapplicationfailedto
meetrequirements.Iftherearemajorreasonsfornotapprovingtheapplication,theFDAsendsa
CompleteResponseLetter.
•AssumingtheFDAfindseverythingacceptable,a74-dayletterispublished.
•Inastandardreview,theFDAaimstomakeadecisioninaround10months,whereasa
priorityreviewisexpectedtotakeabout6months

17. APPROVAL OF NEW DRUG IN INDIA

18. PREPARATION OF DOCUMENTS FOR EXPORT REGISTRATION
Exportissellingofgoodstotheothercountriescrossingthegeographicalfrontiers
ofthecountry.
GuidelinesfortheexportofdrugissuedbyMinistryOfHealthAndFamilyWelfare.
Theseproceduresalsoinvolveconsiderabledocumentationrequirements.
AmanufacturerholdingvalidlicensecopyinForm-25&Form-28canobtainNo
ObjectionCertificatefromZonal/SubZonalofficesofCentralDrugsStandard
ControlOrganization(CDSCO)forexportpurposeonlyforapproved/unapproved
newDrugsfromIndia.

19. REQUIRED DOCUMENTS
Thefollowingdocumentsarerequiredtobesubmittedinthefollowingmannerandorderforissueof
theNoObjectionCertificateforexportofdrugsfromindia.

20. •Itincludesdetailsoftheexporterandimporter,purposeofthe
shipment,Adescriptionoftheproductsbeingshipped.
Covering letter
•Itincludesorderdetailslikequantities,deliverytime,payment
terms
Purchase order
•Itincludesmanufacturingentity,includingnameandaddress,
typesofdrugsthatcanbemanufacturedunderthelicense
Manufacturing licence

21. •AcopyofthePerformainvoicefromtheimportingcountryshould
accompanywiththeapplicationforimportofunapprovedActive
PharmaceuticalIngredients,usedinthedrugformulation,itshould
bedulysignedbythecompetentauthority.
Performa invoice
•Aregistrationcertificateisanofficialdocumentthatconfirmsthat
adrughasbeenregisteredwiththerelevanthealthauthorities.
•Itincludesproductdetails,manufacturerinformation,regulatory
approval,validity.
Registration certificate

22. RULES
RULE 94
•Packingandlabelingofdrugsotherthan
HomeopathicMedicines
•Labelsonpackagesorcontainersofdrugsforexport
shouldbeadaptedtomeetthesollicrequirementsof
thelawofthecountrytowhichthedrug
istobeexported
Nameofthedrug
Name&addressofthemanufacturerandthenumber
ofthelicenseunderwhich,thedrughasbeen
manufactured
Batchorlotnumber
Dateofexpiry,ifany
RULE 95
•Prohibitionofsaleordistributionunlesslabelled.
•Subjecttotheotherprovisionsoftheserules,nopersonshouldsellordistibuteany
drug(includingapatentorproprietarymedicine)unlessitislabelled.
RULE 96
•Manneroflabelling
•Printedorwritteninindelibleink&shouldappearinaconspicuousmanneronthe
labeloftheinnermostcontainerofanydrugandoneveryothercoveringinwhich,
thecontainerispacked,namely
Nameofthedrug
FordrugsincludedinthePharmacopoeias,
ScheduleForScheduleF(1),NationalFormularyofIndia.

23. Ensure the drug meets the regulations of both the exporting and import
countries.
Makesure the drug is made according to quality standards.
Identify the premises where, the drug will be manufactured for export
Batch to be exported has undergone Quality control testing.
Getall necessary documents ready, like export licenses, certificates
showing the drug’s quality and shipping paperwork
Keep the drugs stored correctly during transport to maintain their
effectiveness.
GUIDELINES FOR EXPORT DRUG

24. REFERENCES
•LeeK,BacchettiP,SimI.Publicationofclinicaltrialssupportingsuccessfulnewdrugapplications:a
literatureanalysis.PLoSmedicine.2008Sep;5(9):e191.
•LipskyMS,SharpLK.Fromideatomarket:thedrugapprovalprocess.TheJournaloftheAmerican
BoardofFamilyPractice.2001Sep1;14(5):362-7.
•TheNewDrugApprovalProcess.AccessedonAUG19,2011.
•Clinicaltrialregistration:astatementfromtheInternationalCommitteeofMedicalJournalEditors.Med.J.
Aust.181,2004,293-94.

25. Thank you
for
listening