Fundamentals of Pharmaceutical and Biologic Regulations: A Global Perspective
xiv Regulatory Affairs Professionals Society
Table 26-11a. Overview of Expedited Approval Pathways in Japan: SAKIGAKE, Conditional Early Pathway and Priority
Review ..................................................................................................................................................................................................375
Table 26-11b. Overview of Expedited Approval Pathways in Japan: Orphan Drug Review, Recruitment for Unapproved Drugs
and Indications, and Emergency Approval ...........................................................................................................................................377
Table 26-12. Overview of Expedited Approval Pathways in South Korea ...................................................................................................381
Table 26-13. Overview of Expedited Approval Pathways in New Zealand .................................................................................................382
Table 26-14. Overview of Expedited Approval Pathways in Taiwan ...........................................................................................................385
Table 26-15. Overview of ASEAN Joint Assessment Procedure .................................................................................................................387
Table 26-16. Overview of Approval Pathways in Brunei .............................................................................................................................388
Table 26-17. Overview of Expedited Pathways in Cambodia ......................................................................................................................388
Table 26-18. Overview of Expedited Regulatory Pathways in Indonesia .....................................................................................................389
Table 26-19. Orphan Drug Designation in Malaysia ..................................................................................................................................390
Table 26-20. Expedited Regulatory Pathways in Malaysia ..........................................................................................................................390
Table 26-21. Overview of the Expedited Regulatory Pathways in Philippines ............................................................................................392
Table 26-22. Overview of Expedited Pathways in Singapore ......................................................................................................................393
Table 26-23. Eligible Criteria for a Drug to be Considered on the List of Rare Drugs in Vietnam ............................................................395
Table 27-1. Country Requirements ..............................................................................................................................................................402
Table 27-2. Regulatory Authority and Country Legal Framework ..............................................................................................................407
Table 27-3. Content and Format Requirements ..........................................................................................................................................412
Table 27-4. Translation Requirements .........................................................................................................................................................419
Table 27-5. Dossier Requirement for Collaborative and Reliance Procedures .............................................................................................424
Table 27-6. Country-Specific Dossier Requirements Related to Selected Described Pathways ..................................................................425
Table 27-7. Combination Product Definitions ............................................................................................................................................435
Table 27-8. Combination Product Definitions in Additional Regions ........................................................................................................437
Table 28-1. Examples of the Different Combination Product Categories ...................................................................................................452
Table 28-2. Summary of Regulation of Combination Products in Several Asian Jurisdictions.................................................................... 459
Table 28-3. LATAM Recognition ...............................................................................................................................................................460
Table 29-1. Regulatory Framework for Postauthorization Studies in Major America Regions ...................................................................468
Table 29-2. Regulations and Guidance Documents in China ......................................................................................................................474
Table 31-1. Americas: Comparison of Regulations Across Jurisdictions .....................................................................................................496
Table 31-2. NMRAs and Guidelines for Pharmaceuticals in African Countries .........................................................................................510
Table 32-1. Regulations and Guidance for GPvP Management and Reporting ..........................................................................................519
Table 32-2. PRAC Scope of Recommendations ..........................................................................................................................................522
Table 32-3. EU Mutual Recognition Agreements .......................................................................................................................................523
Table 34-1. MAH Reporting Requirements ................................................................................................................................................537
Table 36-1. Summary of Time From EMA Authorization to HTA Decision and Outcome .....................................................................572
Table 36-2. Overview of Reference Pricing and Country Baskets in Europe............................................................................................... 575
Table 36-3. HTA and Associated Organizations in Selected EU Member States and the UK ...................................................................580
Table 36-4. Comparison of HTA in Germany, France, UK, Italy, and Spain............................................................................................. 581
Table 36-5. Drugs Eligible for CADTH’s Drug Review Processes .............................................................................................................583
Table 36-6. Summary of CADTH’s Elements and Recommendation Categories ......................................................................................584
Table 36-7. Regulatory Authorities of the BRICS Region and Their Product Categories for Controlled Pricing .....................................585
Table 36-8. Types of Drug Categories Followed in Brazil for Price Fixation ..............................................................................................586
Table 36-9. Types of Regulatory Programs and Reimbursement Methods in Russia ..................................................................................587
Table 36-10. Summary of HTA Status in Select Asian Countries ..............................................................................................................589
Table 36-11. Selected Products for Japan’s MHLW 3-Year HTA Pilot Evaluation ...................................................................................591
Table 36-12. MaHTAS 1995–2018 Impact Overview ................................................................................................................................594
Table 36-13. Regulatory Authorities and Pricing Models in South Asia .....................................................................................................595
xiv Regulatory Affairs Professionals Society
Table 26-11a. Overview of Expedited Approval Pathways in Japan: SAKIGAKE, Conditional Early Pathway and Priority
Review ..................................................................................................................................................................................................375
Table 26-11b. Overview of Expedited Approval Pathways in Japan: Orphan Drug Review, Recruitment for Unapproved Drugs
and Indications, and Emergency Approval ...........................................................................................................................................377
Table 26-12. Overview of Expedited Approval Pathways in South Korea ...................................................................................................381
Table 26-13. Overview of Expedited Approval Pathways in New Zealand .................................................................................................382
Table 26-14. Overview of Expedited Approval Pathways in Taiwan ...........................................................................................................385
Table 26-15. Overview of ASEAN Joint Assessment Procedure .................................................................................................................387
Table 26-16. Overview of Approval Pathways in Brunei .............................................................................................................................388
Table 26-17. Overview of Expedited Pathways in Cambodia ......................................................................................................................388
Table 26-18. Overview of Expedited Regulatory Pathways in Indonesia .....................................................................................................389
Table 26-19. Orphan Drug Designation in Malaysia ..................................................................................................................................390
Table 26-20. Expedited Regulatory Pathways in Malaysia ..........................................................................................................................390
Table 26-21. Overview of the Expedited Regulatory Pathways in Philippines ............................................................................................392
Table 26-22. Overview of Expedited Pathways in Singapore ......................................................................................................................393
Table 26-23. Eligible Criteria for a Drug to be Considered on the List of Rare Drugs in Vietnam ............................................................395
Table 27-1. Country Requirements ..............................................................................................................................................................402
Table 27-2. Regulatory Authority and Country Legal Framework ..............................................................................................................407
Table 27-3. Content and Format Requirements ..........................................................................................................................................412
Table 27-4. Translation Requirements .........................................................................................................................................................419
Table 27-5. Dossier Requirement for Collaborative and Reliance Procedures .............................................................................................424
Table 27-6. Country-Specific Dossier Requirements Related to Selected Described Pathways ..................................................................425
Table 27-7. Combination Product Definitions ............................................................................................................................................435
Table 27-8. Combination Product Definitions in Additional Regions ........................................................................................................437
Table 28-1. Examples of the Different Combination Product Categories ...................................................................................................452
Table 28-2. Summary of Regulation of Combination Products in Several Asian Jurisdictions.................................................................... 459
Table 28-3. LATAM Recognition ...............................................................................................................................................................460
Table 29-1. Regulatory Framework for Postauthorization Studies in Major America Regions ...................................................................468
Table 29-2. Regulations and Guidance Documents in China ......................................................................................................................474
Table 31-1. Americas: Comparison of Regulations Across Jurisdictions .....................................................................................................496
Table 31-2. NMRAs and Guidelines for Pharmaceuticals in African Countries .........................................................................................510
Table 32-1. Regulations and Guidance for GPvP Management and Reporting ..........................................................................................519
Table 32-2. PRAC Scope of Recommendations ..........................................................................................................................................522
Table 32-3. EU Mutual Recognition Agreements .......................................................................................................................................523
Table 34-1. MAH Reporting Requirements ................................................................................................................................................537
Table 36-1. Summary of Time From EMA Authorization to HTA Decision and Outcome .....................................................................572
Table 36-2. Overview of Reference Pricing and Country Baskets in Europe............................................................................................... 575
Table 36-3. HTA and Associated Organizations in Selected EU Member States and the UK ...................................................................580
Table 36-4. Comparison of HTA in Germany, France, UK, Italy, and Spain............................................................................................. 581
Table 36-5. Drugs Eligible for CADTH’s Drug Review Processes .............................................................................................................583
Table 36-6. Summary of CADTH’s Elements and Recommendation Categories ......................................................................................584
Table 36-7. Regulatory Authorities of the BRICS Region and Their Product Categories for Controlled Pricing .....................................585
Table 36-8. Types of Drug Categories Followed in Brazil for Price Fixation ..............................................................................................586
Table 36-9. Types of Regulatory Programs and Reimbursement Methods in Russia ..................................................................................587
Table 36-10. Summary of HTA Status in Select Asian Countries ..............................................................................................................589
Table 36-11. Selected Products for Japan’s MHLW 3-Year HTA Pilot Evaluation ...................................................................................591
Table 36-12. MaHTAS 1995–2018 Impact Overview ................................................................................................................................594
Table 36-13. Regulatory Authorities and Pricing Models in South Asia .....................................................................................................595