THERAPEUTIC PRODUCTS GUIDANCE
嚜澤ugust 2024
THERAPEUTIC PRODUCTS GUIDANCE
GUIDANCE ON THERAPEUTIC PRODUCT
REGISTRATION IN SINGAPORE
TPB-GN-005-013
Please visit HSA＊s Guidelines on Therapeutic Product Registration
webpage for the latest updates
GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE
AUGUST 2024
REVISION HISTORY
Guidance Version (Publish Date)
TPB-GN-005-013 (Version 13; Updated 31 July 2024)
HEALTH SCIENCES AUTHORITY 每 HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE
AUGUST 2024
TABLE OF CONTENTS
CHAPTER A
GENERAL OVERVIEW ............................................................................. 11
1
FOREWORD .............................................................................................................. 11
1.1 Scope of This Guidance Document .............................................................. 11
1.2 Therapeutic Product Registration.................................................................. 13
2
APPLICANT AND REGISTRANT RESPONSIBILITIES .............................................. 15
3
WHETHER A THERAPEUTIC PRODUCT IS SUBJECT TO PATENT ....................... 16
4
PROTECTION OF CONFIDENTIAL SUPPORTING INFORMATION AND
REGISTRATION EXCLUSIVITY ................................................................................ 18
CHAPTER B
REGISTRATION PROCESS ..................................................................... 19
5
PRE-SUBMISSION PREPARATION .......................................................................... 20
5.1 Product Types .............................................................................................. 20
5.2 Application Types ......................................................................................... 20
5.3 Evaluation Routes ........................................................................................ 23
5.4 Pre-Submission Consultation Mechanisms ................................................... 23
5.4.1
Pre-Submission Notification ............................................................ 24
5.4.2
Pre-Submission Meeting ................................................................. 24
6
APPLICATION SUBMISSION .................................................................................... 25
6.1 PRISM Application Form .............................................................................. 25
6.2 Application Dossier ....................................................................................... 26
6.2.1
Submission Requirements .............................................................. 27
6.2.2
Language and Translation............................................................... 29
6.2.3
Certifying Non-Original Documents ................................................. 31
7
APPLICATION SCREENING ..................................................................................... 32
8
APPLICATION EVALUATION .................................................................................... 33
8.1 Evaluation Stages ......................................................................................... 34
9
REGULATORY DECISION ........................................................................................ 36
10 POST-APPROVAL CHANGES................................................................................... 38
11 TARGET PROCESSING TIMELINES ........................................................................ 38
12 FEES.......................................................................................................................... 38
12.1 Screening Fee .............................................................................................. 38
12.2 Evaluation Fee.............................................................................................. 39
12.2.1 Changes to Application Types and Re-routing of Evaluation During
Screening........................................................................................ 40
CHAPTER C
NEW DRUG APPLICATION SUBMISSION ............................................... 42
13 APPLICATION TYPES ............................................................................................... 42
14 EVALUATION ROUTES ............................................................................................. 43
14.1 Full Evaluation Route.................................................................................... 43
14.2 Abridged Evaluation Route ........................................................................... 43
14.2.1 Priority Review ................................................................................ 44
14.3 Verification Evaluation Route ........................................................................ 45
14.3.1 NDA-3 Applications ......................................................................... 47
15 DOCUMENTARY REQUIREMENTS .......................................................................... 47
15.1 Administrative Documents ............................................................................ 48
15.2 CTD Overview and Summaries..................................................................... 65
15.3 Quality Documents ....................................................................................... 65
15.3.1 Body of Data 每 Drug Substance ...................................................... 65
15.3.2 Body of Data 每 Drug Product .......................................................... 69
15.4 Non-clinical Documents ................................................................................ 74
15.5 Clinical Documents ....................................................................................... 74
15.6 Documentary Requirements for Each Evaluation Route ............................... 75
15.6.1 Full Evaluation Route ...................................................................... 75
HEALTH SCIENCES AUTHORITY 每 HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE
AUGUST 2024
15.6.2 Abridged Evaluation Route.............................................................. 76
15.6.3 Verification Evaluation Route .......................................................... 76
CHAPTER D
GENERIC DRUG APPLICATION SUBMISSION ....................................... 81
16 APPLICATION TYPES ............................................................................................... 81
16.1 Generic Product ............................................................................................ 81
16.2 Singapore Reference Product ....................................................................... 82
17 EVALUATION ROUTES ............................................................................................. 83
17.1 Abridged Evaluation Route ........................................................................... 83
17.2 Verification Evaluation Route ........................................................................ 83
18 DOCUMENTARY REQUIREMENTS .......................................................................... 85
18.1 Administrative Documents ............................................................................ 86
18.2 CTD Overview and Summaries................................................................... 100
18.3 Quality Documents ..................................................................................... 100
18.3.1 Body of Data 每 Drug Substance .................................................... 100
18.3.2 Body of Data 每 Drug Product ........................................................ 104
18.4 Non-clinical and Clinical Documents ........................................................... 111
18.5 Documentary Requirements for Each Evaluation Route ............................. 112
18.5.1 Abridged Evaluation Route............................................................ 112
18.5.2 Verification and Verification-CECA Evaluation Routes .................. 112
18.6 Documentary Requirements for Second Brand Registration of Chemical
Therapeutic Products.................................................................................. 117
18.6.1 Definition ....................................................................................... 117
18.6.2 Documentary Requirements.......................................................... 117
CHAPTER E
BIOSIMILAR PRODUCT APPLICATION SUBMISSION .......................... 119
19 APPLICATION TYPES ............................................................................................. 119
19.1 Biosimilar Product ....................................................................................... 120
19.2 Singapore Reference Biological Product..................................................... 120
20 EVALUATION ROUTES ........................................................................................... 121
20.1 Abridged Evaluation Route ......................................................................... 122
20.2 Verification Evaluation Route ...................................................................... 122
20.2.1 NDA-3 Applications ....................................................................... 124
21 DOCUMENTARY REQUIREMENTS ........................................................................ 124
21.1 Administrative Documents .......................................................................... 125
21.2 CTD Overviews and Summaries ................................................................. 125
21.3 Quality Documents ..................................................................................... 125
21.4 Non-clinical and Clinical Documents ........................................................... 127
21.4.1 Non-clinical Documentation........................................................... 128
21.4.2 Clinical Documentation ................................................................. 128
21.5 Documentary Requirements for Each Evaluation Route ............................. 130
21.5.1 Abridged Evaluation Route............................................................ 130
21.5.2 Verification Evaluation Route ........................................................ 131
CHAPTER F
POST-APPROVAL PROCESS ................................................................ 135
22 APPLICATION TYPES ............................................................................................. 135
23 VARIATION APPLICATION PROCESS ................................................................... 137
23.1 Pre-Submission Consultation Mechanisms ................................................. 137
23.1.1 Pre-Submission Notification .......................................................... 138
23.2 Application Submission ............................................................................... 138
23.2.1 PRISM Application Form ............................................................... 138
23.2.2 Variation Application Dossier ........................................................ 138
23.3 Application Screening ................................................................................. 142
23.4 Application Evaluation and Regulatory Decision ......................................... 143
23.5 Target Processing Timelines ...................................................................... 147
23.6 Fees ........................................................................................................... 147
23.6.1 Screening Fee............................................................................... 147
23.6.2 Evaluation Fee .............................................................................. 148
23.6.3 Application Fee ............................................................................. 150
HEALTH SCIENCES AUTHORITY 每 HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE
AUGUST 2024
CHAPTER G
MAJOR VARIATION (MAV) APPLICATION SUBMISSION ..................... 151
24 MAV-1 APPLICATIONS ........................................................................................... 151
24.1 Evaluation Routes ...................................................................................... 151
24.1.1 Full Evaluation Route .................................................................... 152
24.1.2 Abridged Evaluation Route............................................................ 152
24.1.3 Verification Evaluation Route ........................................................ 152
24.2 Documentary Requirements ....................................................................... 154
24.2.1 Administrative Documents............................................................. 155
24.2.2 CTD Overviews and Summaries ................................................... 156
24.2.3 Quality Documents ........................................................................ 156
24.2.4 Non-clinical and Clinical Documents ............................................. 156
24.2.5 Documentary Requirements for Each Evaluation Route ................ 157
25 MAV-2 APPLICATIONS ........................................................................................... 159
25.1 Evaluation Routes ...................................................................................... 159
25.2 Eligibility Criteria ......................................................................................... 159
25.3 Documentary Requirements ....................................................................... 160
25.4 ＆Me-too＊ Reclassification ............................................................................. 161
CHAPTER H
MINOR VARIATION (MIV) APPLICATION SUBMISSION ....................... 162
26 APPLICATION TYPES ............................................................................................. 162
27 APPLICATION SUBMISSION .................................................................................. 163
27.1 MIV-1 Applications ...................................................................................... 164
27.1.1 Submitting multiple/consequential changes................................... 164
27.2 MIV-2 Applications ...................................................................................... 165
27.2.1 MIV-2 Notification .......................................................................... 165
27.2.2 MIV-2 Do-and-Tell ......................................................................... 165
HEALTH SCIENCES AUTHORITY 每 HEALTH PRODUCTS REGULATION GROUP
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