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7/29/2019 02_Basics of Application Filing
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All Rights Reserved 2008 Health Sciences Authority | 2
Basics of ApplicationFiling
Ms Jalene Poh
Senior Regulatory Specialist
Pharmaceuticals & Biologics BranchTherapeutics Products Division
Health Products Regulation Group
Health Sciences Authority
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Agenda
• Introduction
• Pre-submission Preparations• New Drug/Generic Drug Applications
– PRISM Application
– Dossier Requirements
– Submission Requirements– Documentary Requirements
• Post-Approval Variation Applications– PRISM Application
– Dossier & Submission Requirements
– Documentary Requirements
• Final Note
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Introduction
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Medicinal Product Registration
HSA’s commitment:Make quality, safe and effective medicines
available in Singapore in a timely manner
Need Pharma’s cooperation and support
Help Us Help You !
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Screening Process
Application Submission
Screening
Issue Deficiency Letter
YOUR Stop-Clock
Screen Response
Acceptance
Join Evaluation Queue
Non-Acceptance
MajorDeficiencies
25 w.d.
Receipt of Complete Dossier
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Importance of a Proper Submission
• Importance of getting the application
submission right the first time– Prevent non-acceptance
– Reduce YOUR screening deficiencies
– Reduce YOUR stop-clock time
¨ Reduce overall processing timeline for YOUR application
Familiarise yourself with the requirements
Consult HSA
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Pre-SubmissionPreparations
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Pre-Submission Preparations
• Compiling all necessary documents
• Organise in CTD format
• Discuss with HSA:– Clarifications/questions
– Difficulties in meeting requirements
– Alternative proposals
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Pre-Submission Preparations
• Pre-submission inquiry:
HSA_MedProd_Registration@hsa.gov.sg• For issues on MIV submissions
– MIV Filing and Submission Inquiry Form (App 13)
– Include a copy of the Inquiry form in the MIVsubmission
• Pre-submission consultation
– For more complex issues
– Prior to a full dossier submission– Request via email to
HSA_MedProd_Registration@hsa.gov.sg
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New Drug Application
Generic Drug Application
- PRISM Application
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PRISM Application
• Online applications via PRISM
(Pharmaceutical Regulatory and InformationSystem)
• Separate application form required for:
– Each pharmaceutical dosage form and strength
– Powder for injections containing different amountsof drug substance per container
– Concentrates for reconstitution labelled with theactual amount of drug substance before
reconstitution
– Pre-filled syringes
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PRISM Application
400 iu/4 ml
Submit as 2 separate applications:One as NDA-1/GDA-1 and the other as NDA-3/GDA-2
100 iu/mlPre-filledsyringe
5
Submit as a single application with two pack
sizes (i.e., 5ml and 10ml)
2mg/ml: presented
in 5ml vial and 10mlvial
Concentrate4
20mg/10ml
Submit as 2 separate applications:One as NDA-1/GDA-1 and the other as NDA-3/GDA-2
10mg/5mlConcentrate3
2mg/ml pre-filled
syringe
Submit as 2 separate applications:One as NDA-1/GDA-1 and the other as NDA-2/GDA-1
2mg/ml in a vialSolution forInjection
2
50mg/vial
Submit as 2 separate applications:One as NDA-1/GDA-1 and the other as NDA-3/GDA-2
25mg/vialPowder forInjection
1
Application typeLabelled strengthbefore
reconstitution
Examples
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Section 1: Company particulars
Section 2: Applicant particulars
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Company address
may be entered
Direct telephone and faxnumbers in companymay be entered
PRISM Application
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Section 3: Application details
PRISM ApplicationPg15
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Section 3: Application details (cont’d)
• Type of application (3.1):– Change within same application type (e.g. NDA-2 to
NDA-3)
¨ Input request to amend
– Change to a different application type (e.g. NDA-1to GDA-1)
¨ Application to be withdrawn and submit newapplication
PRISM Application
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PRISM Application
Section 3: Application details (cont’d)
• Reference Product (3.3):– NDA-3 application not submitted at the same time
as the NDA-1/2 application
¨ state NDA-1/2 product’s SIN no.
– All GDA applications¨ state Singapore Reference Product’s SIN no.
– GDA-2 application not submitted at the same timeas the GDA-1 application
¨ state both Singapore Reference Product andGDA-1 product’s SIN nos
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Section 4: Product Information
Section 4.1: Product Name
• Product’s trade name shown on product labelling
ABC Injection 5mg/ml USP
ProductStandard(optional)
ProductStrength
PharmaceuticalDosage Form
Product Name
PRISM Application
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Trans-Patch® 24mg/24 hrsState the amount of activeingredient released in 2 4
h o u r s
Transdermal patches
Ingredient® 300mg per vialState the amount of activeingredient b e f o r e
reconstitution or dilution
Powder forreconstitution, injectionor infusion
Antibiotic® 200mg/5mLState the concentration a f t e r
reconstitutionPowder forreconstitution, oral
per mL, per puff, per drop,per kg, per m2, etc.
State the concentrationMulti-dose preparation
Ingredient® 300mg per vialState the amount of activeingredient per unit dose
Single-dose preparation,total use
Multi-Tab® Tablet
100mg/25mg
Strength of each active
ingredient separated by a ‘/’
Fixed-combination
ExampleFormatProduct
PRISM Application
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Section 4.2: Product Formula
PRISM ApplicationPg18
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Section 4.2: Product Formula (cont’d)
• Ingredients related to pharmaceutical dosage form
Film coating ingredient
Printing ink
PRISM Application
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Section 4.2: Product Formula (cont’d)
• Active substance present in the form of a salt
Enter the strengthof the a c t i v e
s u b s t a n c e b a s e
here.
PRISM Application
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This strengthwill actually beentered here
Section 4.2: Product Formula (cont’d)
• Information on residual amounts of certain materials,such as antibiotics, thiomersal and materials of biological origin (e.g. human serum albumin), added orpresent in the drug product must be declared
PRISM Application
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• Refer to Appendix 10 & 11 for details on datarequirements
PRISM Application
Section 4.3: Ingredients derived from Human
Blood/Animal Sources
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• Section 4.4: Pharmacotherapeutic group
• Section 4.5: Dosage form
• Section 4.6: Route of administration
PRISM ApplicationPg21
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PRISM Application
Section 4.7: Packaging, Shelf-life & StorageConditions
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PRISM Application
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Section 4.8: Forensic Classification
• Prescription Only Medicine (POM)
• Pharmacy only medicine (P)
• General Sales List medicine (GSL)
PRISM ApplicationPg24
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PRISM Application Pg25
Section 4.9: Registration Status in Other Countries
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State the expectedsubmission date
-PENDINGSUBMISSION
State the expected
regulatory decision date,if applicable
State the submission
date
PENDING
EVALUATION
For allreferenceagencies andcountry of origin (if
applicable)
State the approvedindication(s) and dosingregimen(s)
State the approvaldate
APPROVAL
State the reason(s)State the date of
deferment
DEFERRAL
State the reason(s)State the date of rejection/withdrawal
REJECTION orWITHDRAWAL
-State the approvaldateAPPROVALFor ALLcountries
Application DetailsStatus DateApplicationStatus
Country
PRISM Application
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PRISM Application
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Section 4.9: Registration Status in OtherCountries (cont’d)
• In the event that the PRISM text space does not allowinput of full details of the indication(s), dosingregimen(s), and/or reason(s), a brief description maybe entered
• The full details should be attached in softcopy (PDF) inPRISM section 7 (Supporting Attachments) and inhardcopy in section 1.16 of the CTD Module 1/Part 1
PRISM Application
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POMAdjuvant treatment of colorectal cancer stage III(Dukes C) following complete removal of primary
tumour.Notice of Compliance with Conditions issued on 16April 2003 based on promising efficacy results withcondition to furnish confirmatory efficacy data
21 Nov 2004ApprovedCountry 4
POMAdjuvant treatment of colorectal cancer stage III(Dukes C) following surgery.
Submitted:15 Jun 2005
PendingCountry 5
POMIndication submitted ‘Adjuvant treatment of colorectalcancer’. Withdrawn due to insufficient long-term
efficacy data (only phase II data submitted). Re-submitted on 16 June 2005 with completed phase IIIdata for ‘Adjuvant treatment of colorectal cancerfollowing surgery’.
14 April 2002Withdrawnby applicant
Country 3
POMAdjuvant treatment of colorectal cancer followingsurgery
2 Feb 2006ApprovedCountry 2
POMAdjuvant treatment of colorectal cancer stage III
(Dukes C) following complete resection of primarytumour.
12 Jan 2005ApprovedCountry 1
Approvedforensic
classification
Approved application indication/dosing regimendetails
Status DateApplicationStatus
Country
PRISM Application
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Section 4.10: Product Owner Information
– Input the full name and address of the legallyregistered owner of the product formulation, i.e.the drug product
PRISM ApplicationPg28
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PRISM Application
Section 5: Manufacturers’ Particulars
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Section 5: Manufacturers’ Particulars (cont’d)
• Enter information on all manufacturers of activesubstance(s), drug product and diluent used toreconstitute the product (if packed and sold togetherwith the drug product)
• For secondary packagers, enter ‘(Secondary packager)’
after the name of the manufacturer
• All manufacturers’ names and addresses should beconsistent throughout all of the documents submittedin the application, such as GMP certificates, CPP’s,
Letters of Authorisation, Module 3/Part II of the CTDand so forth
PRISM Application
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Section 6: Batch Release Details
PRISM ApplicationPg29
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Section 7: Supporting Documents
• Before completion of the application, applicants mustattach all Module 1/Part 1 documents into this PRISMsection
• Notes:
– Use Portable Document Format (PDF) whenever possible
– Do not combine documents if the content is unrelated
– Ensure that the documents are appropriately named foreasier recognition to facilitate screening
– During scanning of documents, applicants are advised
not to break seals of authenticated documents as this willrender them invalid
PRISM ApplicationPg30
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PRISM Application
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New Drug Application
Generic Drug Application
- Dossier Requirements
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• The submission of the complete dossiershould take place within 2 working days afterthe PRISM application submission to preventdelays in processing of the application
• The date of submission will be defined as the
date when HSA receives the complete datasetfor the application
• Dossier requirements for each applicationtype & dossier type
– Main guidance document
– Application Checklists (Appendix 2/3)
Dossier RequirementsPg31
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Dossier Requirements
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Dossier Requirements
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New Drug Application
Generic Drug Application
- Submission Requirements
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Submission Requirements
Requirement of both hard and soft copiesof submission dossier
Default: Electronic Copy Only
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• An electronic copy of the complete CTDdossier is to be submitted with the application
– Module 1/Part 1 in PRISM section 7
– Remaining Modules/Parts in PRISM or CD
Don’t combine PRISM attachments with a CDsubmission
• Hardcopy submission of all admin documentsin CTD Module 1/Part 1 still required
• When applicable, upon acceptance, additional
copy(ies) of clinical documents (in CD) maybe requested
Submission RequirementsPg37
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• Do’s
– Ensure that e-copies for scanned documents are
legible
– For CD submission, organise the dossier in the CTDformat, using folders and subfolders and includebookmarks
– Ensure access to CD is not restricted (or providepassword for access)
– Electronic copies are identical to the hardcopydocuments (for admin documents)
Submission Requirements
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New Drug Application
Generic Drug Application
- Documentary Requirements
D t R i t
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1.1: Comprehensive Table of Contents
1.2: Introduction
1.3: Application form
1.4: Labelling, PI, PIL
– Separate drafts for each different pack size
– Must be in English; If not, provide an officialstatement to declare that the non-English text iscomplete, accurate and unbiased information and isconsistent with the English text
– Refer Appendix 6 for specific details of labellingrequirements
Documentary Requirements
- Administrative DocumentsPg40
D t R i t
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1.5: Approved SmPC/PI/PIL
– Country of Origin
– Agency that issued proof of approval (if not COO)
– Each of HSA’s reference agencies (if approved)
1.6: Assessment report from Reference Agency
1.7: Description of Batch Numbering System1.8, 1.9: Proof of Approval
1.10: Authorisation Letters
1.11: GMP Certification– Must not expire within 6 months from the time of
submission
Documentary Requirements
- Administrative DocumentsPg41
Documentary Requirements
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1.12: Patent Declaration Form
– Section 1: Applicant Particulars
Name & address of local applicant firm– Section 2: Product Particulars
Product name is stated and it should be consistent with thatstated in PRISM, all product labelling and all other relevantdocuments in the dossier
– Section 8: Declaration
Signed by person authorised to make the declaration onbehalf of the applicant ,e.g. the Company Director,Company Secretary as registered with ACRA, or equivalent
Evidence of authorisation to be submitted, e.g. resolution of board of directors, resolution of a general meeting of thecompany, or an extract of the relevant portion of thecompany’s articles of association
Documentary Requirements
- Administrative DocumentsPg43
Documentary Requirements
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1.13: Declaration on rejection, withdrawal and
deferral
1.14: Declaration for NDA verification
– Only for NDA verification dossiers
1.15: Registration status in other countries
Documentary Requirements
- Administrative Documents Pg44
Documentary Requirements
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• CTD Overview and Summaries
– Module 2 of the ICH CTD
– Relevant sections in Part 2, 3 and 4 of the ACTD
• Quality Documents
– Complete Module 3/Part 2
• Non-clinical Documents (NDAs only)
– Full dossier: Complete set of Module 4/Part 3
– Other dossier types: Non-clinical overview
Documentary Requirements
- Technical DocumentsPg44
Pg48
Documentary Requirements
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• Clinical (NDAs only)
– Full dossier: Complete Module 5/Part 4
– Other dossier types: Study reports of pivotal clinicalstudies
Studies should be conducted using the proposedcommercial formulation, and in the appropriate
patient population for the proposed indication(s) anddosing regimen
Biopharmaceutic study reports are required if thecommercial formulation differ from the clinical trialformulation used in the pivotal clinical studies
Documentary Requirements
- Technical DocumentsPg49
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Post-ApprovalVariation Application
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PRISM Application• Similar to NDA/GDA application
• Some fields would not be editable dependingon the application type
• Detail all proposed change(s) in theAmendment Summary section
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PRISM Application• Section 3.1: Type of Application
– Change from MIV to MAV-1, MIV-2 to MIV-1, or
vice versa
¨ Application to be withdrawn and submit newapplication
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Submission Requirements• The submission of the complete dossier should take
place within 2 working days after the PRISM application
submission to prevent delays in processing of theapplication
• The date of submission will be defined as the datewhen HSA receives the complete dataset for the
application• An electronic copy of the CTD dossier is to be
submitted with the application
– Module 1/Part 1 in PRISM section 7
– Remaining Modules/Parts in PRISM or CD• Hardcopy submission of all admin documents in CTD
Module 1/Part 1 still required
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Documentary Requirements• MAV-1
– Detailed in the Application Checklists (Appendix
2/3)
• MAV-2
– Detailed in Section 10.3.2 (page 59-60)
• MIV-1/MIV-2
– Detailed in Minor Variation Guidelines (Appendix
14/15)
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Final Note
Screening Process
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Screening Process
Application Submission
Screening
Issue Deficiency Letter
YOUR Stop-Clock
Screen Response
Acceptance
Join Evaluation Queue
Non-Acceptance
MajorDeficiencies
25 w.d.
Receipt of Complete Dossier
Screening Process
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Sc ee g ocess
Application Submission
Screening
Acceptance
Join Evaluation Queue
25 w.d.
Receipt of Complete Dossier
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Thank You
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