xvi Regulatory Affairs Professionals Society (RAPS)
Table 28-3: EU Mutual Recognition Agreements. .......................................................................................................................................453
Table 30-1. MAH Reporting Requirements. ................................................................................................................................................470
Table 31-1. Common Scenarios Considered False, Lacking in Fair Balance, or Otherwise Misleading by FDA. ........................................483
Table 32-1. Drugs Eligible for CADTH’s Drug Review Processes............................................................................................................... 504
Table 32-2. Summary of CADTH’s Elements and Recommendation Categories........................................................................................ 505
Table 32-3. Latin American Country-Specific HTA Overview.................................................................................................................... 505
Table 32-4. Summary of Time From EMA Authorisation to HTA Decision and Outcome....................................................................... 507
Table 32-5. HTA and Associated Organizations in Selected EU Member States and the UK..................................................................... 511
Table 32-6. Overview of Reference Pricing and Country Baskets in Europe................................................................................................ 512
Table 32-7. Comparison of HTA in Germany, France, UK, Italy, and Spain. ...............................................................................................517
Table 32-8. Summary of HTA Status in Select Asian Countries.................................................................................................................. 518
Table 32-9. Regulatory Authorities of BRIC region and their Product Categories for Controlled Pricing. .................................................523
Table 32-10. Types of Drug Categories followed in Brazil for price fixation. ...............................................................................................524
Table 32-11. Types of Regulatory Programs and Reimbursement Methods in Russia.................................................................................. 525
Table 32-12. 13 Selected Products for Japan MHLW 3-Year HTA Pilot Evaluation................................................................................... 528
Table 32-13. MaHTAS 1995–2018 Impact Overview.................................................................................................................................. 531
Table 32-14. Regulatory Authorities and Pricing Models in South Asia. .....................................................................................................532
Table 28-3: EU Mutual Recognition Agreements. .......................................................................................................................................453
Table 30-1. MAH Reporting Requirements. ................................................................................................................................................470
Table 31-1. Common Scenarios Considered False, Lacking in Fair Balance, or Otherwise Misleading by FDA. ........................................483
Table 32-1. Drugs Eligible for CADTH’s Drug Review Processes............................................................................................................... 504
Table 32-2. Summary of CADTH’s Elements and Recommendation Categories........................................................................................ 505
Table 32-3. Latin American Country-Specific HTA Overview.................................................................................................................... 505
Table 32-4. Summary of Time From EMA Authorisation to HTA Decision and Outcome....................................................................... 507
Table 32-5. HTA and Associated Organizations in Selected EU Member States and the UK..................................................................... 511
Table 32-6. Overview of Reference Pricing and Country Baskets in Europe................................................................................................ 512
Table 32-7. Comparison of HTA in Germany, France, UK, Italy, and Spain. ...............................................................................................517
Table 32-8. Summary of HTA Status in Select Asian Countries.................................................................................................................. 518
Table 32-9. Regulatory Authorities of BRIC region and their Product Categories for Controlled Pricing. .................................................523
Table 32-10. Types of Drug Categories followed in Brazil for price fixation. ...............................................................................................524
Table 32-11. Types of Regulatory Programs and Reimbursement Methods in Russia.................................................................................. 525
Table 32-12. 13 Selected Products for Japan MHLW 3-Year HTA Pilot Evaluation................................................................................... 528
Table 32-13. MaHTAS 1995–2018 Impact Overview.................................................................................................................................. 531
Table 32-14. Regulatory Authorities and Pricing Models in South Asia. .....................................................................................................532