xv
Table 19-1. Comparison of Pediatric Development Regulations................................................................................................................... 267
Table 20-1. Time to Regulatory Authority and Ethics Board Approvals in an MRCT................................................................................ 278
Table 20-2. Clinical Trial Applications in North America (Canada, Mexico, US). .......................................................................................279
Table 20-3. Clinical Trial Applications in Europe (EU, Switzerland, UK).................................................................................................... 279
Table 20-4. Clinical Trial Applications in BRICS Countries........................................................................................................................ 280
Table 20-5. Clinical Trial Applications in South America (Argentina, Colombia, Chile, Peru).................................................................... 280
Table 20-6. Clinical Trial Applications in Select Asia-Pacific (APAC) Countries........................................................................................ 281
Table 20-7. Clinical Trial Applications in Select Middle East/North Africa (MENA) Countries. ..............................................................281
Table 21-1. A Brief History of the Evolving BRA Initiatives, Methods, and Procedures. ............................................................................286
Table 21-2. UMBRA Steps and Process. ......................................................................................................................................................291
Table 22-1. Advantages and Disadvantages of eCTD................................................................................................................................... 296
Table 22-2. Example of Folder Names in eCTD. .........................................................................................................................................301
Table 22-3. Error Severity. ............................................................................................................................................................................301
Table 22-4. eCTD 4.0 Implementation Schedule as per ICH Guideline July 2022. ....................................................................................302
Table 23-1. Overview of Expedited Approval Programs in the US............................................................................................................... 307
Table 23-2. Overview of Expedited Approval Pathways in Argentina. .........................................................................................................308
Table 23-3. Overview of Expedited Approval Pathways in Canada.............................................................................................................. 309
Table 23-4. Overview of Expedited Approval Pathways in Mexico. .............................................................................................................310
Table 23-5. Comparison of Conditional Marketing Authorization and Marketing Authorization Under Exceptional Circumstances. ......312
Table 23-6. Overview of Accelerated Approval Pathways in EU, Switzerland, UK, and Turkey................................................................... 317
Table 23-7. Overview of Expedited Approval Pathways in Brazil................................................................................................................. 319
Table 23-8. Summary of Expedited Approval Pathways in India.................................................................................................................. 320
Table 23-9. Overview of Expedited Approval Pathways in China. ...............................................................................................................322
Table 23-10. Overview of Expedited Approval Pathways in Australia.......................................................................................................... 323
Table 23-11a. Overview of Expedited Approval Pathways in Japan: SAKIGAKE, Conditional Early Pathway and Priority Review. ........324
Table 23-11b. Overview of Expedited Approval Pathways in Japan – Orphan Drug Review, Recruitment for Unapproved Drugs and
Indications, and Emergency Approval..................................................................................................................................................... 325
Table 23-12. Overview of Expedited Approval Pathways in South Korea. ...................................................................................................329
Table 23-13. Overview of Expedited Approval Pathways in New Zealand................................................................................................... 330
Table 23-14. Overview of Expedited Approval Pathways in Taiwan............................................................................................................. 332
Table 23-15. Overview of ASEAN Joint Assessment Procedure. .................................................................................................................334
Table 23-16. Overview of Approval Pathways in Brunei............................................................................................................................... 335
Table 23-17. Overview of Expedited Pathways in Cambodia. ......................................................................................................................336
Table 23-18. Overview of Expedited Regulatory Pathways in Indonesia...................................................................................................... 336
Table 23-19. Orphan Drug Designation in Malaysia.................................................................................................................................... 338
Table 23-20. Expedited Regulatory Pathways in Malaysia............................................................................................................................ 338
Table 23-21. Overview of the Expedited Regulatory Pathways in Philippines. ............................................................................................340
Table 23-22. Overview of Expedited Pathways in Singapore........................................................................................................................ 341
Table 23-23. Eligible Criteria for a Drug to be Considered on the List of Rare Drugs in Vietnam............................................................. 343
Table 23-24. Overview of Expedited Approval Pathways in Saudi Arabia. ..................................................................................................345
Table 24-1. Country Requirements. ..............................................................................................................................................................354
Table 24-2. Regulatory Authority and Country Legal Framework. ..............................................................................................................360
Table 24-3. Content and Format Requirements............................................................................................................................................ 370
Table 24-4. Country Requirements. ..............................................................................................................................................................375
Table 24-5. Dossier Requirement for Collaborative and Reliance Procedures, ACCESS Consortium......................................................... 379
Table 24-6. Country-Specific Dossier Requirements Related to Selected Described Pathways.................................................................... 380
Table 24-7. Combination Product Definitions.............................................................................................................................................. 387
Table 24-8. Combination Product Definitions in Additional Regions.......................................................................................................... 390
Table 25-1. Regulatory Framework for Postauthorization Studies in Major America Regions.................................................................... 396
Table 25-2. Regulations and Guidance Documents. .....................................................................................................................................402
Table 26-1. Postapproval Regulations in Each MENA Country. .................................................................................................................420
Table 27-1. Americas: Comparison of Regulations Across Jurisdictions....................................................................................................... 429
Table 27-2. NMRAs and Guidelines for Pharmaceuticals in African Countries. .........................................................................................442
Table 28-1. Regulations and Guidance for GPvP Management and Reporting. ..........................................................................................448
Table 28-2: PRAC Scope of Recommendations. ..........................................................................................................................................453
Table 19-1. Comparison of Pediatric Development Regulations................................................................................................................... 267
Table 20-1. Time to Regulatory Authority and Ethics Board Approvals in an MRCT................................................................................ 278
Table 20-2. Clinical Trial Applications in North America (Canada, Mexico, US). .......................................................................................279
Table 20-3. Clinical Trial Applications in Europe (EU, Switzerland, UK).................................................................................................... 279
Table 20-4. Clinical Trial Applications in BRICS Countries........................................................................................................................ 280
Table 20-5. Clinical Trial Applications in South America (Argentina, Colombia, Chile, Peru).................................................................... 280
Table 20-6. Clinical Trial Applications in Select Asia-Pacific (APAC) Countries........................................................................................ 281
Table 20-7. Clinical Trial Applications in Select Middle East/North Africa (MENA) Countries. ..............................................................281
Table 21-1. A Brief History of the Evolving BRA Initiatives, Methods, and Procedures. ............................................................................286
Table 21-2. UMBRA Steps and Process. ......................................................................................................................................................291
Table 22-1. Advantages and Disadvantages of eCTD................................................................................................................................... 296
Table 22-2. Example of Folder Names in eCTD. .........................................................................................................................................301
Table 22-3. Error Severity. ............................................................................................................................................................................301
Table 22-4. eCTD 4.0 Implementation Schedule as per ICH Guideline July 2022. ....................................................................................302
Table 23-1. Overview of Expedited Approval Programs in the US............................................................................................................... 307
Table 23-2. Overview of Expedited Approval Pathways in Argentina. .........................................................................................................308
Table 23-3. Overview of Expedited Approval Pathways in Canada.............................................................................................................. 309
Table 23-4. Overview of Expedited Approval Pathways in Mexico. .............................................................................................................310
Table 23-5. Comparison of Conditional Marketing Authorization and Marketing Authorization Under Exceptional Circumstances. ......312
Table 23-6. Overview of Accelerated Approval Pathways in EU, Switzerland, UK, and Turkey................................................................... 317
Table 23-7. Overview of Expedited Approval Pathways in Brazil................................................................................................................. 319
Table 23-8. Summary of Expedited Approval Pathways in India.................................................................................................................. 320
Table 23-9. Overview of Expedited Approval Pathways in China. ...............................................................................................................322
Table 23-10. Overview of Expedited Approval Pathways in Australia.......................................................................................................... 323
Table 23-11a. Overview of Expedited Approval Pathways in Japan: SAKIGAKE, Conditional Early Pathway and Priority Review. ........324
Table 23-11b. Overview of Expedited Approval Pathways in Japan – Orphan Drug Review, Recruitment for Unapproved Drugs and
Indications, and Emergency Approval..................................................................................................................................................... 325
Table 23-12. Overview of Expedited Approval Pathways in South Korea. ...................................................................................................329
Table 23-13. Overview of Expedited Approval Pathways in New Zealand................................................................................................... 330
Table 23-14. Overview of Expedited Approval Pathways in Taiwan............................................................................................................. 332
Table 23-15. Overview of ASEAN Joint Assessment Procedure. .................................................................................................................334
Table 23-16. Overview of Approval Pathways in Brunei............................................................................................................................... 335
Table 23-17. Overview of Expedited Pathways in Cambodia. ......................................................................................................................336
Table 23-18. Overview of Expedited Regulatory Pathways in Indonesia...................................................................................................... 336
Table 23-19. Orphan Drug Designation in Malaysia.................................................................................................................................... 338
Table 23-20. Expedited Regulatory Pathways in Malaysia............................................................................................................................ 338
Table 23-21. Overview of the Expedited Regulatory Pathways in Philippines. ............................................................................................340
Table 23-22. Overview of Expedited Pathways in Singapore........................................................................................................................ 341
Table 23-23. Eligible Criteria for a Drug to be Considered on the List of Rare Drugs in Vietnam............................................................. 343
Table 23-24. Overview of Expedited Approval Pathways in Saudi Arabia. ..................................................................................................345
Table 24-1. Country Requirements. ..............................................................................................................................................................354
Table 24-2. Regulatory Authority and Country Legal Framework. ..............................................................................................................360
Table 24-3. Content and Format Requirements............................................................................................................................................ 370
Table 24-4. Country Requirements. ..............................................................................................................................................................375
Table 24-5. Dossier Requirement for Collaborative and Reliance Procedures, ACCESS Consortium......................................................... 379
Table 24-6. Country-Specific Dossier Requirements Related to Selected Described Pathways.................................................................... 380
Table 24-7. Combination Product Definitions.............................................................................................................................................. 387
Table 24-8. Combination Product Definitions in Additional Regions.......................................................................................................... 390
Table 25-1. Regulatory Framework for Postauthorization Studies in Major America Regions.................................................................... 396
Table 25-2. Regulations and Guidance Documents. .....................................................................................................................................402
Table 26-1. Postapproval Regulations in Each MENA Country. .................................................................................................................420
Table 27-1. Americas: Comparison of Regulations Across Jurisdictions....................................................................................................... 429
Table 27-2. NMRAs and Guidelines for Pharmaceuticals in African Countries. .........................................................................................442
Table 28-1. Regulations and Guidance for GPvP Management and Reporting. ..........................................................................................448
Table 28-2: PRAC Scope of Recommendations. ..........................................................................................................................................453