Appendix 3 Application Checklist ACTD

GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ACTD)
JANUARY 2009
APPENDIX 3 APPLICATION CHECKLIST (ACTD)

This Application Checklist should be used to ensure submission of a complete dataset in the ASEAN 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 ASEAN guidance on ACTD for explanatory notes on the preparation of documents for a submission in ACTD format.
HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP
Appendix 3 - Page 1 of 17
JANUARY 2009
Part I Administrative Documentation

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

1.2
Include a complete list of all documents provided in the application dossier by Part The location of each document should be identified by the Part 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 ACTD 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
JANUARY 2009
Application Type Section Documents Dossier Type NDA MAV-1 GDA MAV-2
ACTD 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)
JANUARY 2009
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
JANUARY 2009
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 type 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
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 Part 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 Part 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, Part II of the CTD and so forth
JANUARY 2009
Application Type Section Documents Dossier Type NDA 1.3.6 Section 6: Batch Release Details MAV-1 GDA * MAV-2
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 Part I of the CTD Other Parts Either attach in full in this PRISM section or submit soft copies
1.4 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

1.5.2 1.5.3 reference 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
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
* * *
* * *
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
1.10.3 Owner to the Drug Substance Manufacturer is required Authorisation Letter from Product Owner to the Batch Releaser
This letter authorises the specified company to test and batch release the
drug product
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
For biologics: GMP certification/proof of GMP compliance for each drug substance manufacturer must be provided submission to HSA
Proof of GMP compliance must not expire within 6 months from the time of 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 Part 1
JANUARY 2009
FOR MAV-1, registration status should be attached in this PRISM section (supporting
attachments) and in hardcopy in section 1.15 of the CTD Part 1
JANUARY 2009
Part II Quality
Application Type Section Document Dossier Type NDA MAV-1 GDA ACTD Vol / Page (Vol __ Page __ to __)
For verification dossier The submission should include Part II 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. A Table of Contents of Part II B C Singapore Quality Overall Summary (QOS) & QOS in other format, if available Body of Data Drug Substance (Active substance) S1 General Information S1.1 S1.2 S1.3 S2 Nomenclature Structure General Properties * * * * * *
* *
* *
Manufacture S2.1 S2.2 S2.3 S2.4 S2.5 S2.6 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 * * * * * * * * * * * *
S3
Characterisation S3.1 S3.2 Elucidation of Structure and other Characteristics Impurities Specification of Drug Substance * * * * * *
S4
Control of Drug Substance S4.1

Application Type Section S4.2 S4.3 S4.4 S4.5 S5 S6 S7 Analytical Procedures Validation of Analytical Procedures Batch Analyses Justification of Specification Document Dossier Type NDA * * * * * * * * * * * MAV-1 GDA * * * * * * * * * * *
JANUARY 2009
ACTD Vol / Page (Vol __ Page __ to __)
Reference Standards or Materials Container Closure System Stability S7.1 S7.2 S7.3 Stability Summary and Conclusions Post-approval Stability Protocol and Stability Commitment Stability Data
Drug Product P1 P2 Description and Composition of the Drug Product Pharmaceutical Development P2.1 P2.2 P2.2.1 P2.2.2 P2.3 P2.3.1 P2.3.2 P2.3.3 P2.4 P2.5 P2.6 Information on Development Studies Components of the Drug Product Active Ingredients Excipients Finished Product Formulation Development Overages Physicochemical and Biological Properties Manufacturing Process Development Container Closure System Microbiological Attributes * * * * * * * * * * * * * *

Application Type Section Document Dossier Type NDA * * * * * * * * * MAV-1 GDA * * * * * * * * *
JANUARY 2009
P2.7 P3 P3.1 P3.2 P3.3 P3.4 P4 P4.1 P4.2 P4.3 P4.4 P5
Compatibility Batch Formula Description of Manufacturing Process And Process Controls Controls of Critical Steps and Intermediates Process Validation and/or Evaluation Specifications Analytical Procedures Excipients of Human and Animal Origin Novel Excipients
Manufacture
Control of Excipients
Control of Drug Product (Finished Product) P5.1 P5.2 P5.3 P5.4 P5.5 P5.6 Specification of Drug Product Analytical Procedures Validation of Analytical Procedures Batch Analyses Characterisation of Impurities Justification of Specifications * * * * * * * * * * * * * * * * * * * * * *
P6 P7 P8
Reference Standards or Materials Container Closure System Stability P8.1 P8.2 P8.3 Stability Summary and Conclusions Post-approval Stability Protocol and Stability Commitment Stability Data

Application Type Section P9 D Q Product Interchangeability Document Dossier Type NDA MAV-1 GDA * *
JANUARY 2009
Key Literature References Country-specific Quality Requirements Q1 Q2 Q3 Q4 Checklist for Human Blood Product with the required supporting documents TSE Checklist with the required supporting documents Blank Production Batch Record Appendices A.1 A.2 A.3 Facilities and Equipment Adventitious Agents Safety Evaluation Novel Excipients
JANUARY 2009
Part III Non-clinical Data

Application Type Section Document Dossier Type NDA * * * * MAV-1 GDA ACTD Vol / Page (Vol __ Page __ to __)
A B
Table of Content of Part III Non-clinical Overview B1 B2 General Aspect Content and Structural Format Non-clinical Written Summary C1.1 C1.2 C1.3 C2 Pharmacology Pharmacokinetics Toxicology
Non-clinical Summary (Written and Tabulated) C1
Non-clinical Tabulated Summaries Table of Content Pharmacology D2.1 D2.2 D2.3 D2.4 Primary Pharmacodynamics Secondary Pharmacodynamics Safety Pharmacology Pharmacodynamics Drug Interactions Analytical Methods and Validation Reports Absorption Distribution Metabolism Excretion
* * * * * * * * * * * * * *
Non-clinical Study Report D1 D2
D3
Pharmacokinetics D3.1 D3.2 D3.3 D3.4 D3.5

Application Type Section Document Dossier Type NDA * * * * * * * * * * MAV-1 GDA
JANUARY 2009
D3.6 D3.7 D4 Toxicology D4.1 D4.2 D4.3 D4.4 D4.5 D4.6 D4.7 E
Pharmacokinetics Drug Interaction (non-clinical) Other Pharmacokinetics Studies Single-Dose Toxicity Multiple-Dose Toxicity Genotoxicity Carcinogenicity Reproductive and Developmental Toxicity Local Tolerance Other Toxicity Studies
List of Key Literature References
JANUARY 2009
Part IV Clinical Data

Application Type Section Document Dossier Type NDA * * * * * * * * * * * * * MAV-1 * * GDA MAV-2 ACTD Vol / Page (Vol __ Page __ to __)
A B C
Table of Content of Part IV Clinical Overview Clinical Summary C1 C2 C3 C4 C5 Summary of Biopharmaceutic Studies and Associated Analytical Methods Summary of Clinical Pharmacology Studies Summary of Clinical Efficacy Summary of Clinical Safety Synopses of Individual Studies
D E
Tabular Listing of All Clinical Studies Clinical Study Reports E1 Reports of Biopharmaceutic Studies
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

E2 E3 E4 E5 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials Reports of Human Pharmacokinetic (PK) Studies Reports of Human Pharmacodynamic (PD) Studies Reports of Clinical 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
E6 clinical trials should be submitted (appendices & tables are required upon request by HSA) Reports of Post-marketing Experience

Application Type Section E7 F G Document Case Reports Forms and Individual Patient Listing (required upon request by HSA) Dossier Type NDA MAV-1 GDA MAV-2
JANUARY 2009
List of Key Literature References Other Supporting Documents

Appendix 3 Application Checklist ACTD

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE APPLICATION CHECKLIST (ACTD)