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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

APPENDIX 2

APPLICATION CHECKLIST (ICH CTD)

This Application Checklist should be used to ensure submission of a complete dataset in the ICH CTD format. To use this Checklist, check against the dossier and application type for your submission. For NDA and MAV-1 applications, the document shown in the second column has to be submitted if the symbol representing the dossier type viz. full dossier represented by , abridged dossier by and verification dossier by , and * (under application type) appear on the same row. For GDA and MAV-2 applications, the Dossier Type column does not apply.

Application Type Dossier Type

NDA Full dossier

GDA Abridged dossier

MAV-1 Verification dossier

MAV-2

Note: without the asterisk * indicates that the document shown in the second column of the same row may be optional depending on the application type/product/change concerned. Please refer to the Guidance on Medicinal Product Registration in Singapore and the ICH technical guidance for explanatory notes on the preparation of documents for a submission in ICH CTD format.

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Module 1 Administrative Documentation


Application Type Section Documents Dossier Type NDA 1.1 Comprehensive Table of Contents MAV-1 * GDA * MAV-2 * ICH CTD Vol/Page (Vol __ Page __ to __)


1.2

Include a complete list of all documents provided in the application dossier by Module The location of each document should be identified by the Module number

For hardcopy submissions, the location of each document should be identified by the volume number and tab identifiers (name of document or section heading according to ICH CTD format) Introduction

Provide a concise and precise summary of the application Justify the lack of certain documents and deviation(s) from guidelines
1.3 PRISM Application Form 1.3.1 1.3.2 Section 1: Company Particulars

* * *

* *

Company shall be based and registered in Singapore


Section 2: Applicant particulars * * *

Applicant must be a permanent staff of the company and is residing in


Singapore. If the person making the application / correspondence person is an external party (consultant) engaged by the applicant company, an original letter of authorization from the applicant company must be submitted.

Company address and contact details can be entered instead of personal


1.3.3 residential address and contact details Section 3: Application Details 3.1 3.2 3.3 Type of Application Type of Product Reference Product

* *

* * *

All GDA applications Specify Singapore Reference Products SIN number

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA MAV-1 GDA MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)


3.4 3.5 3.6 1.3.4 4.1

If GDA-2 application not submitted at the same time as GDA-1 application Specify both the Singapore Reference Products and the GDA-1 products SIN numbers

If NDA-3 applications not submitted at the same time as NDA-1/2 application Specify the NDA-1/2s SIN number Product intended for export Type of Dossier Type of Format Product name

* * * *

* * * *

Section 4: Product Information


4.2

Enter in the following format: Product Name - Dosage Form Product Strength Refer to Guidance document section 6.1.4 for additional pointers

Product Formula

Include the full composition of all active substances and excipients (including water) that are present in the final pharmaceutical dosage form Ingredients related to the pharmaceutical dosage form, such as tablet film coating or capsule shell, should be indicated within parentheses before the ingredient name, e.g. (Film coating) Ingredient Z For active ingredients presented in the form of salts and chelate, the quantity should be clearly stated, e.g., XX phosphate 32 mg (equivalent to XX)

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA MAV-1 GDA MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)

Information on residual amounts of certain materials, such as


antibiotics, thiomersal and materials of biological origin (e.g. human serum albumin), added or present in the drug product must be declared. Information to declare includes the following: o the materials name enter (Residual), followed by the materials name in the Name of Substance field; o the materials grade, if applicable; o the materials limit in the product enter , followed by the limit in the Strength field. Ingredients derived from human blood or animal sources

4.3

4.4 4.5 4.6 4.7

Information to be provided in the following format: (Species & product) (In manufacturing/drug substance/excipient) (Country) ATC Code Dosage Form Route of Administration

* * * *

* * * *

Include all routes of administration proposed for the product

Packaging, Shelf Life & Storage Condition Where more than one drug component is included in a drug product (e.g., powder for injection with solvent as composite pack) and each component has a different shelf life, the shorter shelf life is to be used as the shelf life of the composite pack Forensic Classification Registration Status in Other Countries

4.8 4.9

* * *

* *

For each country - State the application status and status date For country of origin and all reference agencies - State the application status, status date, application details and forensic classification

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA MAV-1 GDA MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)

For products approved via an appeal process, following either a negative opinion/rejection/non-approvable decision or an approvable/conditional approvable decision Provide reasons for the initial regulatory decision along with the subsequent approval of application i.e. centralised, decentralised, mutual recognition or national, should be identified; For decentralised and mutual recognition applications, the reference member state should be indicated

For applications submitted to the European Union agencies, the type

For applications approved by the UK MHRA Indicate whether


approval was granted through national procedure or whether MHRA acted as RMS or CMS for decentralised and mutual recognition procedures in European Union

For NDA & GDA, the registration status of the product in other
countries should be entered into PRISM

In the event that the PRISM text space does not allow input of full
details of the indication(s), dosing regimen(s), and/or reason(s), a brief description may be entered; The full details should be attached in softcopy (PDF) in PRISM section 7 (Supporting Attachments) and in hardcopy in section 1.16 of the CTD Module 1

For MAV-1, the registration status should be attached in softcopy


4.10 1.3.5 (PDF) in PRISM section 7 (Supporting Attachments) and in hardcopy in section 1.16 of the CTD Module 1 Product Owner

Section 5: Manufacturers Particulars

* *

* *

All manufacturers of active substance(s), drug product and diluent used to


reconstitute the product (if packed and sold together with the drug product) must be declared

For secondary packagers, enter (Secondary packager) after the name of the
manufacturer

All manufacturers names and addresses should be consistent throughout all


of the documents submitted in the application, such as GMP certificates, CPPs, Letters of authorisation, Module 3 of the CTD and so forth

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA 1.3.6 Section 6: Batch Release Details MAV-1 GDA * MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)

If there are multiple companies responsible for batch release, the applicant
1.3.7 must declare all of the sites Supporting Documents

Attach all documents relating to Module 1 of the CTD Other Modules Either attach in full in this PRISM section or submit soft
1.4 copies in CD Labelling and PI/PIL proposed & currently approved in Singapore. For NDA and GDA only proposed labelling and PI/PIL need to be submitted

Labelling must be in English; If non-English text is included in the labelling, applicants must provide an official statement to declare that the non-English text is complete, accurate and unbiased information and is consistent with the English text

Highlight any non-English country-specific labelling requirements on the artwork/drafts if the labelling is shared with other countries 1.4.1 Outer/Carton Labels 1.4.2 1.4.3 1.4.4 1.5 1.5.1 Inner/Blister Labels Package Insert (PI) Patient Information Leaflet (PIL) SmPC/PI/PIL approved by HSAs reference regulatory agencies

* *

* *

* *

Approved SmPC/PI/PIL

The approved SmPC / PI / PIL currently approved by each of HSAs reference


1.5.2 1.5.3 agencies should be submitted, where applicable SmPC/PI/PIL approved by Country of Origin/Country of Manufacture PI / SmPC / PIL approved by other regulatory agency

The approved SmPC / PI / PIL from the drug regulatory agency that issued
1.5.4 the proof of approval, if different from the Country of Origin If applicable: declaration that the translation of the SmPC/PI/PIL conforms to the SmPC/PI/PIL currently approved

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA 1.6 1.7 1.8 Assessment report issued by HSAs reference regulatory agency: Description of batch numbering system Proof of Approval from: Country of Origin Reference Agency Others: __________________________________________________ Proof of Approval from at least 2 of HSAs reference regulatory agencies Please specify issuing agencies: __________________________________________________ Authorisation Letters
(Please specify)

MAV-1 *

GDA

MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)

* * *

* * *

1.9 1.10

All submitted authorisation letters shall be hardcopy originals on the authorising


companys (i.e. Product Owners) letterhead, dated and signed by the designated authorised person in the company

The names and addresses stated in the letters should be consistent with the
information provided in application form and dossier 1.10.1 Authorisation Letter from Product Owner to the Applicant firm

This letter authorises the local applicant firm to apply for and be the Product
1.10.2 Licence Holder for a specific medicinal product Authorisation Letter from Product Owner to the Manufacturer(s)

This letter authorises the specified manufacturer to produce, pack and/or label
the drug product intended for Singapore

If there are multiple drug product manufacturers, the applicant may opt to
submit one authorisation letter which clearly states all of the manufacturers (names and addresses) and their responsibilities related to the drug product

For biologic drug products, an additional authorisation letter from the Product
Owner to the Drug Substance Manufacturer is required 1.10.3 Authorisation Letter from Product Owner to the Batch Releaser

This letter authorises the specified company to test and batch release the
drug product

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA 1.11 GMP certification/proof of GMP compliance for each finished product manufacturer inclusive secondary packer(s) MAV-1 GDA * MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)

For biologics: GMP certification/proof of GMP compliance for each drug substance manufacturer must be provided to HSA

Proof of GMP compliance must not expire within 6 months from the time of submission Diluents used for reconstituting the drug product and are packaged together with the
drug product will be considered as part of the final drug product; Manufacturer(s) of the supplied diluent(s) will follow the same requirements applicable to the drug product e.g. proof of GMP compliance

The names and addresses of manufacturer(s) / repacker(s) should be consistent with


1.12 information provided in application form Patent declaration form

The Patent Declaration form is required for each NDA and GDA Under Applicant Particulars, name & address of the local applicant firm to be stated Under Product Particulars, the product name is stated and it should be consistent with
that stated in PRISM, the application form, all product labelling and all other relevant documents in the dossier

Under Declaration, the patent declaration must be signed by the Company Director,
1.13 1.14 Company Secretary as registered with ACRA, or equivalent Declaration on rejection, withdrawal and deferral Declaration that Singapore product is identical to current approved product by reference agency

* *

Applies only to NDA verification dossier


1.15 Registration Status in Other Countries as separate attachment in PRISM under [7] Supporting Attachments *

For NDA & GDA, registration status should be entered into PRISM section 4.9; In the
event that the PRISM text space does not allow input of the full details of the indication(s) and/or reason(s), a brief description may be entered; The full details should then be attached in softcopy (PDF) in this PRISM section (supporting attachments) and in hardcopy in section 1.15 of the CTD Module 1

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Documents Dossier Type NDA MAV-1 GDA MAV-2

ICH CTD Vol/Page (Vol __ Page __ to __)

FOR MAV-1, registration status should be attached in this PRISM section (supporting
attachments) and in hardcopy in section 1.15 of the CTD Module 1

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Module 2 Common Technical Document Summaries


Application Type Section Document Dossier Type NDA 2.1 2.2 2.3 2.4 2.5 2.6 Overall CTD Table of Contents of Modules 2, 3, 4 and 5 Introduction Singapore Quality Overall Summary (QOS) & QOS in other format, if available Non-clinical Overview Clinical Overview Non-clinical Summary 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6 2.6.7 2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5 Introduction Pharmacology Written Summary Pharmacology Tabulated Summary Pharmacokinetics Written Summary Pharmacokinetics Tabulated Summary Toxicology Written Summary Toxicology Tabulated Summary Summary of Biopharmaceutics and Associated Analytical Methods Summary of Clinical Pharmacology Studies Summary of Clinical Efficacy Summary of Clinical Safety Synopses of Individual Studies MAV-1 * * GDA * * * * MAV-2 ICH CTD Vol/Page (Vol __ Page __ to __)

* * * * * * * * * * * * * * * * *

Clinical Summary

* * *

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Appendix 2 - Page 10 of 17

GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Module 3 Quality
ICH CTD Vol/Page GDA
(Vol __ Page __ to __)

Application Type Section Document Dossier Type NDA MAV-1

For verification dossier The submission should include Module 3 dossier as originally submitted to the
reference agency, and any documentations submitted to the same reference agency in subsequent variations to the quality aspects of the product. 3.1 Module 3 Table of Contents 3.2 Body of Data 3.2.S Drug Substance (Active Substance) 3.2.S.1 General Information 3.2.S.1.1 3.2.S.1.2 3.2.S.1.3 3.2.S.2 Manufacture 3.2.S.2.1 3.2.S.2.2 3.2.S.2.3 3.2.S.2.4 3.2.S.2.5 3.2.S.2.6 3.2.S.3 Manufacturer(s) Description of Manufacturing Process and Process Controls Control of Materials Controls of Critical Steps and Intermediates Process Validation and/or Evaluation Manufacturing Process Development Nomenclature Structure General Properties

* * *

* * *

* * * * * *

* * * * * *

Characterisation 3.2.S.3.1 3.2.S.3.2 Elucidation of Structure and other Characteristics Impurities Specification of Drug Substance * * * * * *

3.2.S.4

Control of Drug Substance 3.2.S.4.1

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Document Dossier Type NDA 3.2.S.4.2 3.2.S.4.3 3.2.S.4.4 3.2.S.4.5 3.2.S.5 3.2.S.6 3.2.S.7 Analytical Procedures Validation of Analytical Procedures Batch Analyses Justification of Specification MAV-1 GDA * * * * * * * * * *

ICH CTD Vol/Page


(Vol __ Page __ to __)

Reference Standards or Materials Container Closure System Stability 3.2.S.7.1 3.2.S.7.2 3.2.S.7.3 Stability Summary and Conclusions Post-approval Stability Protocol and Stability Commitment Stability Data

* * * * * * * * * *

3.2.P

Drug Product 3.2.P.1 3.2.P.2 Description and Composition of the Drug Product Pharmaceutical Development 3.2.P.2.1 3.2.P.2.1.1 3.2.P.2.1.2 3.2.P.2.2 3.2.P.2.2.1 3.2.P.2.2.2 3.2.P.2.2.3 3.2.P.2.3 3.2.P.2.4 3.2.P.2.5 Components of the Drug Product Drug Substance Excipients Drug Product Formulation Development Overages Physicochemical and Biological Properties Manufacturing Process Development Container Closure System Microbiological Attributes

* *

* *

* * * * * *

* * * * * *

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Document Dossier Type NDA 3.2.P.2.6 3.2.P.3 Manufacture 3.2.P.3.1 3.2.P.3.2 3.2.P.3.3 3.2.P.3.4 3.2.P.3.5 3.2.P.4 3.2.P.4.1 3.2.P.4.2 3.2.P.4.3 3.2.P.4.4 3.2.P.4.5 3.2.P.4.6 3.2.P.5 3.2.P.5.1 3.2.P.5.2 3.2.P.5.3 3.2.P.5.4 3.2.P.5.5 3.2.P.5.6 3.2.P.6 3.2.P.7 Manufacturer(s) Batch Formula Description of Manufacturing Process And Process Controls Controls of Critical Steps and Intermediates Process Validation and/or Evaluation Specifications Analytical Procedures Validation of Analytical Procedures Justification of Specifications Excipients of Human or Animal Origin Novel Excipients Specification(s) of Drug Product Analytical Procedures Validation of Analytical Procedures Batch Analyses Characterisation of Impurities Justification of Specification(s) Compatibility MAV-1 GDA * * * * * * * * * * * * * * * * * * * *

ICH CTD Vol/Page


(Vol __ Page __ to __)

* * * * * * * * * * * * * * * * * * * *

Control of Excipients

Control of Drug Product

Reference Standards or Materials Container Closure System

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Document Dossier Type NDA 3.2.P.8 Stability 3.2.P.8.1 3.2.P.8.2 3.2.P.8.3 3.2.A Appendices 3.2.A.1 3.2.A.2 3.2.A.3 3.2.R 3.2.R.1 3.2.R.2 3.2.R.3 3.2.R.4 3.3 Facilities and Equipment Adventitious Agents Safety Evaluation Novel Excipients Checklist for Human Blood Product with required supporting documents TSE Checklist with required supporting documents Product Interchangeability (Bioequivalence Study Reports) Blank Production Batch Record Stability Summary and Conclusions Post-approval Stability Protocol and Stability Commitment Stability Data MAV-1 GDA

ICH CTD Vol/Page


(Vol __ Page __ to __)

* * *

* * *

Regional Information/Requirements

* *

List of Literature References

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Module 4 Non-clinical Study Reports


Application Type Section Document Dossier Type NDA 4.1 4.2 Module 4 Table of Contents Study Reports 4.2.1 Pharmacology 4.2.1.1 4.2.1.2 4.2.1.3 4.2.1.4 4.2.2 4.2.2.1 4.2.2.2 4.2.2.3 4.2.2.4 4.2.2.5 4.2.2.6 4.2.2.7 4.2.3 Toxicology 4.2.3.1 4.2.3.2 4.2.3.3 4.2.3.4 4.2.3.5 4.2.3.6 4.2.3.7 Single-Dose Toxicity Repeat-Dose Toxicity Genotoxicity Carcinogenicity Reproductive and Developmental Toxicity Local Tolerance Other Toxicity Studies Primary Pharmacodynamics Secondary Pharmacodynamics Safety Pharmacology Pharmacodynamic Drug Interactions Analytical Methods and Validation Reports Absorption Distribution Metabolism Excretion Pharmacokinetic Drug Interactions (non-clinical) Other Pharmacokinetic Studies MAV-1 GDA ICH CTD Vol/Page (Vol
__ Page __ to __)

* * * * * * * * * * * * * * * * * *

Pharmacokinetics

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Application Type Section Document Dossier Type NDA 4.3 List of Literature References MAV-1 GDA

ICH CTD Vol/Page (Vol


__ Page __ to __)

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ICH CTD)

JANUARY 2009

Module 5 Clinical Study Reports


Application Type Section Document Dossier Type NDA 5.1 5.2 5.3 Module 5 Table of Contents Tabular Listings of All Clinical Studies Clinical Study Reports 5.3.1 Reports of Biopharmaceutic Studies MAV-1 * * GDA MAV-2 ICH CTD Vol/Page (Vol __ Page __ to __)

* *

For Abridged and Verification Dossiers: only final study report(s) of


biopharmaceutic studies to establish bioequivalence between commercial product formulation and clinical trial formulation used in pivotal studies should be submitted, if applicable

For Full Dossier, all biopharmaceutic study reports are required


5.3.2 5.3.3 5.3.4 5.3.5 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials Reports of Pharmacokinetic (PK) Studies Reports of Pharmacodynamic (PD) Studies Reports of Efficacy and Safety Studies

* * * * *

For Full Dossier, reports of all clinical trials should be submitted, including the
appendices & tables

For Abridged and Verification Dossiers, only study reports of pivotal or


relevant clinical trials should be submitted (appendices & tables are required upon request by HSA) 5.3.6 Reports of Post-marketing Experience Case Report Forms and Individual Patient Listings (required upon request by 5.3.7 HSA) List of Key Literature References Other Supporting Documents

5.4 5.5

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Appendix 2 - Page 17 of 17