Table Of Contents (TOC) for SINGAPORE

SINGAPORE

Authority

HSA: Health sciences authority singapore

website

www.hsa.gov.sg/publish/hsaportal/en/healthproductsregulation/clinicaltrails.html

if any

REQUIREMENT FOR PRODUCT REGISTRATION

PART - I

Administrative data and product information

1.1

Comprehensive Table  of contents

1.2

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

Section 1: Company Particulars

Section 2: Applicant particulars

Section 3: Applicant details

3.1

Type of application

3.2

Type of product

3.3

Reference product

3.4

Product intended for export

3.5

Type of dossier

3.6

Type of format

Section 4: Product information

4.1

Product Name

4.2

Product formula

4.3

Ingredients  derived  from  human  blood  or animal  sources

4.4

ATC code

4.5

Dosage form

4.6

Route of administration

4.7

Packaging, shelf life and storage condition

4.8

Forensic classification

4.9

Registration status in other countries

4.10

Product owner

Section 5: Manufacturer’s particulars

Section 6: Batch released details

Section 7: Supporting documents

1.4

Labelling and PI/PIL

1.4.1

Outer/Carton Labels

1.4.2

Inner/Blister Labels

1.4.3

Package Insert (PI)

1.4.4

Patient Information Leaflet (PIL)

1.5

Approved SmPC/PI/PIL

1.7

Description of batch numbering system

1.10

Authorisation Letters

1.10.1

Authorisation Letter from Product Owner to the Applicant firm

1.10.2

Authorisation Letter from Product Owner to the Manufacturer(s)

1.10.3

Authorisation Letter from Product Owner to the Batch Releaser

1.11

GMP Certification

1.12

Patent declaration form

1.13

Declaration on rejection, withdrawal and deferral

1.15

Registration  status  in  other  countries  as  separate attachment in PRISM under “supporting attachments”

PART - II

QUALITY

Section A: Table of contents

Section B: Quality overall Summary (QOS) & QOS in other format, if available

Section C: Body of data

DRUG SUBSTANCE

S1

General Information

S1.1

Nomenclature

S1.2

Structural Formula

S1.3

General Properties

S2

Manufacturer

S2.1

Manufacturer (s)

S2.2

Description  of  Manufacturing  Process  and

Process Controls

S2.3

Control of Materials

S2.4

Controls of critical steps on intermediates

S2.5

Process validation and/or evaluation

S2.6

Manufacturing process development

S3

Characterization

S3.1

Elucidation      of         structure          and            other characteristics

S3.2

Impurities

S4

Control of Drug  Substance

S4.1

Specification

S4.2

Analytical procedures

S4.3

Validation of analytical procedures

S4.4

Batch analysis

S4.5

Justification of specification

S5

Reference standards or Materials

S6

Container Closure System

S7

Stability

S7.1

Stability summary and conclusions

S7.2

Post-approval stability protocol and stability commitment

S7.3

Stability indicating nature of test method

S7.4

Stability data

PART - II

Quality

P. DRUG PRODUCT

P1

Description and composition

P2

Pharmaceutical development

P2.1

Information on development studies

P2.2

Components of the drug

P.2.2.1  Active ingredients

P.2.2.2  Excipients

P.2.3

Finished product

P.2.3.1 Formulation Development

P.2.3.2 Overages

P.2.3.3 Physicochemical          and      Biological

Properties

P.2.4

Manufacturing process development

P2.5

Container closer system

P2.6

Microbiological attributes

P2.7

Compatibility

P3

Manufacturer

P3.1

Batch manufacturing formula

P3.2

Manufacturing process and process control

P3.2.1 Manufacturing process flowchart

P3.3

Control of Critical steps and intermediates

P3.4

Process validation and/or evaluation

P4

Control of excipients

P4.1

Specifications

P4.2

Analytical procedures

P4.3

Excipients of Human and Animal Origin

P4.4

Novel Excipients

P5

Control of finished product

P5.1

Specifications

P5.2

Analytical procedures

P5.3

Validations of analytical procedures

P5.4

Batch analysis

P5.5

Characterisation of impurities

P5.6

Justification of specifications

P6

Refference standard of material

P7

Container closer system

P8

Stability

P8.1

Stability summary and conclusions

P8.2

Post approval Stability protocol and stability

Commitment

P.8.3

Stability data

P9

Product interchargeability/equivalence evidence

Section- D Key Literature reference

PART III:

Non clinical data

IIIA

Table of contents

IIIB

Non clinical over view

1.

Over  view  of  non  clinical  testing  strategy

(Product development rational)

2.

Pharmacology

3.

Pharmacokinetics

4.

Toxicology

5.

Integrated overview and conclusion

6.

Literature reference

7.

Information about non – clinical expert

IIIC

Non clinical summary

C1

Non clinical Written summary

C1.1

Pharmacology

C1.2

Pharmacokinetics

C1.3

Toxicology

IIID:   Non clinical study report

PART IV:

Clinical data

IVA

Table of content

IVB

Clinical over view

1.

Product development rational

2.

Overview of biopharmaceutics

3.

Overview of clinical pharmacology

4.

Overview of efficacy

5.

Overview of safety

6.

Benefits and risks conclusions

7.

Literature reference

8.

Information about clinical expert

IVC

Clinical summary

IVD

Tabulated list of all clinical studies

IVE

Clinical study report