Regulatory Affairs Professionals Society xiii
Table 15-11. Comparison of Agency Guidelines on Multidose Presentations ............................................................................................190
Table 15-12. Regulatory Requirements and Guidance for Combination Products in Key Geographical Areas ..........................................191
Table 17-1. Key Documents Required for Clinical Trial Application Submission: US ...............................................................................219
Table 17-2. Changes to EU Legislation for the Conduct of Clinical Trials, 2022 to 2025 .........................................................................219
Table 17-3. Key Documents Required for Initial Clinical Trial Application Submission: EU ....................................................................220
Table 17-4. Data Requirements for Clinical Investigation Stage: BRICS, APAC, and MENA Countries ...............................................222
Table 17-5. Comparison of Data Requirements for Marketing Application Stage: BRICS, APAC, and MENA Countries ....................222
Table 18-1. Phase I–IV Clinical/Regulatory Terminology ..........................................................................................................................230
Table 18-2. APAC Countries and Respective Regulatory Authorities ........................................................................................................245
Table 18-3. Middle East/North Africa Countries and Respective Regulatory Authorities .........................................................................249
Table 18-4. Countries of Africa and Their Respective Regulatory Authorities ...........................................................................................251
Table 19-1. US Clinical Trial Participant Cross-Section Distribution by Sex, Race, and Age for Select Therapeutic Areas .....................260
Table 19-2. Percentage of Pfizer Studies with Patient Participation at or Above US Census Levels Across Therapy Areas ......................262
Table 19-3. FDA Diversity Action Plan Elements ......................................................................................................................................266
Table 19-4. Government of Canada Historical GBA Plus Initiatives and Activity Timeline...................................................................... 267
Table 20-1. Formal Meetings Negotiated Under PDUFA (Timelines) ......................................................................................................277
Table 20-2. Formal Meetings Negotiated Under BsUFA (Timelines) ........................................................................................................278
Table 20-3. CDA-AMC Scientific Advice Process .....................................................................................................................................281
Table 20-4. CDA-AMC Scientific Advice at a Glance ...............................................................................................................................281
Table 20-5. Key Timelines for CDA-AMC Scientific Advice Offerings ....................................................................................................282
Table 20-6. Types of Questions for EMA Scientific Advice .......................................................................................................................283
Table 20-7. Parallel Scientific Advice Timelines.......................................................................................................................................... 284
Table 20-8. EU/EEA National Competent Authorities and Scientific Advice ...........................................................................................285
Table 20-9. Simultaneous NCA Participating Countries, Second Phase Pilot ............................................................................................290
Table 20-10. PMDA Categories and Content of Consultations for New Medicinal Products ...................................................................293
Table 21-1. Comparison of Pediatric Development Regulations .................................................................................................................310
Table 22-1. Time to Regulatory Authority and Ethics Board Approvals in an MRCT ..............................................................................320
Table 22-2. Clinical Trial Applications in North America (Canada, US) ...................................................................................................321
Table 22-3. Clinical Trial Applications in Europe (EU, Switzerland, UK) .................................................................................................321
Table 22-4. Clinical Trial Applications in BRICS Countries ......................................................................................................................322
Table 22-5. Clinical Trial Applications in LATAM Countries ...................................................................................................................322
Table 22-6. Clinical Trial Applications in Asia ...........................................................................................................................................323
Table 22-7. Clinical Trial Applications in Oceania .....................................................................................................................................323
Table 22-8. Clinical Trial Applications in Select MENA Countries ...........................................................................................................324
Table 23-1. Distinctions Between Core Labeling and Regional and Local Data Sheets .............................................................................330
Table 23-2. Sample Structure of a CCDS Based on EU SmPC Headings .................................................................................................331
Table 23-3. Possible Reasons for Discrepancies Between Local Labeling and Core Labeling ....................................................................333
Table 24-1. A Brief History of the Evolving BRA Initiatives, Methods, and Procedures ...........................................................................338
Table 24-2. UMBRA Steps and Process ......................................................................................................................................................343
Table 25-1. Advantages and Disadvantages of Electronic Versus Paper-Based CTD Applications ............................................................350
Table 25-2. Error Severity ............................................................................................................................................................................355
Table 25-3. eCTD 4.0 Implementation Schedule as per ICH Guideline ....................................................................................................356
Table 26-1. Overview of Expedited Approval Programs in the US .............................................................................................................361
Table 26-2. Overview of Expedited Approval Pathways in Argentina .........................................................................................................362
Table 26-3. Overview of Expedited Approval Pathways in Canada .............................................................................................................362
Table 26-4. Overview of Expedited Approval Pathways in Mexico .............................................................................................................363
Table 26-5. Comparison of Conditional Marketing Authorization and Marketing Authorization Under Exceptional
Circumstances .......................................................................................................................................................................................365
Table 26-6. Overview of Accelerated Approval Pathways in the EU, Switzerland, the UK, and Turkey ....................................................368
Table 26-7. Overview of Expedited Approval Pathways in Brazil ...............................................................................................................370
Table 26-8. Summary of Expedited Approval Pathways in India ................................................................................................................371
Table 26-9. Overview of Expedited Approval Pathways in China ...............................................................................................................373
Table 26-10. Overview of Expedited Approval Pathways in Australia ........................................................................................................374
Table 15-11. Comparison of Agency Guidelines on Multidose Presentations ............................................................................................190
Table 15-12. Regulatory Requirements and Guidance for Combination Products in Key Geographical Areas ..........................................191
Table 17-1. Key Documents Required for Clinical Trial Application Submission: US ...............................................................................219
Table 17-2. Changes to EU Legislation for the Conduct of Clinical Trials, 2022 to 2025 .........................................................................219
Table 17-3. Key Documents Required for Initial Clinical Trial Application Submission: EU ....................................................................220
Table 17-4. Data Requirements for Clinical Investigation Stage: BRICS, APAC, and MENA Countries ...............................................222
Table 17-5. Comparison of Data Requirements for Marketing Application Stage: BRICS, APAC, and MENA Countries ....................222
Table 18-1. Phase I–IV Clinical/Regulatory Terminology ..........................................................................................................................230
Table 18-2. APAC Countries and Respective Regulatory Authorities ........................................................................................................245
Table 18-3. Middle East/North Africa Countries and Respective Regulatory Authorities .........................................................................249
Table 18-4. Countries of Africa and Their Respective Regulatory Authorities ...........................................................................................251
Table 19-1. US Clinical Trial Participant Cross-Section Distribution by Sex, Race, and Age for Select Therapeutic Areas .....................260
Table 19-2. Percentage of Pfizer Studies with Patient Participation at or Above US Census Levels Across Therapy Areas ......................262
Table 19-3. FDA Diversity Action Plan Elements ......................................................................................................................................266
Table 19-4. Government of Canada Historical GBA Plus Initiatives and Activity Timeline...................................................................... 267
Table 20-1. Formal Meetings Negotiated Under PDUFA (Timelines) ......................................................................................................277
Table 20-2. Formal Meetings Negotiated Under BsUFA (Timelines) ........................................................................................................278
Table 20-3. CDA-AMC Scientific Advice Process .....................................................................................................................................281
Table 20-4. CDA-AMC Scientific Advice at a Glance ...............................................................................................................................281
Table 20-5. Key Timelines for CDA-AMC Scientific Advice Offerings ....................................................................................................282
Table 20-6. Types of Questions for EMA Scientific Advice .......................................................................................................................283
Table 20-7. Parallel Scientific Advice Timelines.......................................................................................................................................... 284
Table 20-8. EU/EEA National Competent Authorities and Scientific Advice ...........................................................................................285
Table 20-9. Simultaneous NCA Participating Countries, Second Phase Pilot ............................................................................................290
Table 20-10. PMDA Categories and Content of Consultations for New Medicinal Products ...................................................................293
Table 21-1. Comparison of Pediatric Development Regulations .................................................................................................................310
Table 22-1. Time to Regulatory Authority and Ethics Board Approvals in an MRCT ..............................................................................320
Table 22-2. Clinical Trial Applications in North America (Canada, US) ...................................................................................................321
Table 22-3. Clinical Trial Applications in Europe (EU, Switzerland, UK) .................................................................................................321
Table 22-4. Clinical Trial Applications in BRICS Countries ......................................................................................................................322
Table 22-5. Clinical Trial Applications in LATAM Countries ...................................................................................................................322
Table 22-6. Clinical Trial Applications in Asia ...........................................................................................................................................323
Table 22-7. Clinical Trial Applications in Oceania .....................................................................................................................................323
Table 22-8. Clinical Trial Applications in Select MENA Countries ...........................................................................................................324
Table 23-1. Distinctions Between Core Labeling and Regional and Local Data Sheets .............................................................................330
Table 23-2. Sample Structure of a CCDS Based on EU SmPC Headings .................................................................................................331
Table 23-3. Possible Reasons for Discrepancies Between Local Labeling and Core Labeling ....................................................................333
Table 24-1. A Brief History of the Evolving BRA Initiatives, Methods, and Procedures ...........................................................................338
Table 24-2. UMBRA Steps and Process ......................................................................................................................................................343
Table 25-1. Advantages and Disadvantages of Electronic Versus Paper-Based CTD Applications ............................................................350
Table 25-2. Error Severity ............................................................................................................................................................................355
Table 25-3. eCTD 4.0 Implementation Schedule as per ICH Guideline ....................................................................................................356
Table 26-1. Overview of Expedited Approval Programs in the US .............................................................................................................361
Table 26-2. Overview of Expedited Approval Pathways in Argentina .........................................................................................................362
Table 26-3. Overview of Expedited Approval Pathways in Canada .............................................................................................................362
Table 26-4. Overview of Expedited Approval Pathways in Mexico .............................................................................................................363
Table 26-5. Comparison of Conditional Marketing Authorization and Marketing Authorization Under Exceptional
Circumstances .......................................................................................................................................................................................365
Table 26-6. Overview of Accelerated Approval Pathways in the EU, Switzerland, the UK, and Turkey ....................................................368
Table 26-7. Overview of Expedited Approval Pathways in Brazil ...............................................................................................................370
Table 26-8. Summary of Expedited Approval Pathways in India ................................................................................................................371
Table 26-9. Overview of Expedited Approval Pathways in China ...............................................................................................................373
Table 26-10. Overview of Expedited Approval Pathways in Australia ........................................................................................................374