Global Pediatric Development of Drugs, Biologics, and Medical Devices
v
Table 8-1. PIP Scenarios. ..................................................................................................................99
Table 8-2. PIP Scenarios and Compliance Check Requirements.................................................... 104
Table 8-3. Steps for Submission and Assessment for Pediatric Studies to MHRA......................... 105
Table 9-1. Scientific Document Template ......................................................................................110
Table 10-1. Comparison of Japan, US, and EU Pediatric Development Regulations........................ 114
Table 10-2. Timeline of Key Initiatives Supporting Pediatric Development in Japan....................... 115
Table 10-3. Timeline of Key Japan Pediatric Development Incentives............................................. 116
Table 11-1. The TGA Medical Device Classification System. ..........................................................122
Table 11-2. The New Zealand Medical Device Classification System.............................................. 125
Table 12-1. Overview of Pediatric Directives, Laws, and Regulations............................................... 131
Table 12-2. Pediatric Technical Guidance Documents...................................................................... 133
Table 12-3. Overview of Consultation Meetings With CDE. ..........................................................138
Table 13-1. Timeline of Disease Regulations/Initiatives in India...................................................... 145
Table 13-2. Schedules Related to Drug Development Under the Drugs and Cosmetics
Rules, 1945. ....................................................................................................................147
Table 13-3. Key Marketing Applications in India. ............................................................................151
Table 14-1. Benefits........................................................................................................................... 159
Table 14-2. Tools............................................................................................................................... 160
Table 14-3. Clinical Trial and Marketing Authorization Requirements............................................ 161
Table 14-4. Market Access/Reimbursement/Pricing......................................................................... 162
Figures
Figure 2-1. Overview of the Pediatric Study Plan Review Process. ....................................................16
Figure 3-1. Number and Types of Priority Review Vouchers Granted................................................ 40
Figure 7-1. Phases of the PIP. ............................................................................................................82
Figure 8-1. Assessment Pathways for UK-PIPs from 1 January 2021............................................... 102
Figure 8-2. Assessment Pathways for UK-PIP Modifications From 1 January 2021........................ 103
Figure 10-1. Japan Unapproved Drug Scheme Workflow................................................................... 115
Figure 10-2. Pediatric Drugs Working Group Stakeholder and Process Overview ...........................116
Figure 12-1. Marketing Authorization Procedures. ............................................................................139
Figure 13-1. Drug Approval Process................................................................................................... 150
Figure 14-1. Middle East and North Africa Population. ....................................................................156
Figure 14-2. ASEAN Population........................................................................................................ 157
Figure 14-3. APAC Region Population. .............................................................................................158
Abbreviations and Acronyms. ...............................................................................................................165
Glossary................................................................................................................................................. 171
Index..................................................................................................................................................... 177
v
Table 8-1. PIP Scenarios. ..................................................................................................................99
Table 8-2. PIP Scenarios and Compliance Check Requirements.................................................... 104
Table 8-3. Steps for Submission and Assessment for Pediatric Studies to MHRA......................... 105
Table 9-1. Scientific Document Template ......................................................................................110
Table 10-1. Comparison of Japan, US, and EU Pediatric Development Regulations........................ 114
Table 10-2. Timeline of Key Initiatives Supporting Pediatric Development in Japan....................... 115
Table 10-3. Timeline of Key Japan Pediatric Development Incentives............................................. 116
Table 11-1. The TGA Medical Device Classification System. ..........................................................122
Table 11-2. The New Zealand Medical Device Classification System.............................................. 125
Table 12-1. Overview of Pediatric Directives, Laws, and Regulations............................................... 131
Table 12-2. Pediatric Technical Guidance Documents...................................................................... 133
Table 12-3. Overview of Consultation Meetings With CDE. ..........................................................138
Table 13-1. Timeline of Disease Regulations/Initiatives in India...................................................... 145
Table 13-2. Schedules Related to Drug Development Under the Drugs and Cosmetics
Rules, 1945. ....................................................................................................................147
Table 13-3. Key Marketing Applications in India. ............................................................................151
Table 14-1. Benefits........................................................................................................................... 159
Table 14-2. Tools............................................................................................................................... 160
Table 14-3. Clinical Trial and Marketing Authorization Requirements............................................ 161
Table 14-4. Market Access/Reimbursement/Pricing......................................................................... 162
Figures
Figure 2-1. Overview of the Pediatric Study Plan Review Process. ....................................................16
Figure 3-1. Number and Types of Priority Review Vouchers Granted................................................ 40
Figure 7-1. Phases of the PIP. ............................................................................................................82
Figure 8-1. Assessment Pathways for UK-PIPs from 1 January 2021............................................... 102
Figure 8-2. Assessment Pathways for UK-PIP Modifications From 1 January 2021........................ 103
Figure 10-1. Japan Unapproved Drug Scheme Workflow................................................................... 115
Figure 10-2. Pediatric Drugs Working Group Stakeholder and Process Overview ...........................116
Figure 12-1. Marketing Authorization Procedures. ............................................................................139
Figure 13-1. Drug Approval Process................................................................................................... 150
Figure 14-1. Middle East and North Africa Population. ....................................................................156
Figure 14-2. ASEAN Population........................................................................................................ 157
Figure 14-3. APAC Region Population. .............................................................................................158
Abbreviations and Acronyms. ...............................................................................................................165
Glossary................................................................................................................................................. 171
Index..................................................................................................................................................... 177