GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE AUGUST 2024
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 4 of 168
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 – Drug Substance .................................................... 100
18.3.2 Body of Data – 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