Conducting Clinical Trials in Emerging Markets

Table of Contents

ABBREVIATIONS

• 1.1 Introduction to emerging markets
• 1.2 Introduction to report structure, tables and sources

• 2.1 General information
• 2.2 Clinical trials specific information
• 2.3 Clinical trial activity
• 2.4 Looking forward
• 2.5 Summary for India

• 3.1 General information
• 3.2 Clinical trials specific information
• 3.3 Clinical trial activity
• 3.4 Summary for China

• 4.1 Hong Kong
  • 4.1.1 General information
  • 4.1.2 Clinical trials specific information
• 4.2 Republic of (South) Korea
  • 4.2.1 General information
  • 4.2.2 Clinical trials specific information
• 4.3 Malaysia
  • 4.3.1 General information
  • 4.3.2 Clinical trials specific information
• 4.4 Philippines
  • 4.4.1 General information
  • 4.4.2 Clinical trials specific information
• 4.5 Singapore
  • 4.5.1 General information
  • 4.5.2 Clinical trials specific information
• 4.6 Taiwan
  • 4.6.1 General information
  • 4.6.2 Clinical trials specific information
• 4.7 Thailand
  • 4.7.1 General information
  • 4.7.2 Clinical trials specific information
• 4.8 Clinical trial activity: South East Asia
• 4.9 Summary for region

• 5.1 Bulgaria
  • 5.1.1 General information
  • 5.1.2 Clinical trials specific information
• 5.2 Croatia
  • 5.2.1 General information
  • 5.2.2 Clinical trials specific information
• 5.3 Czech Republic
  • 5.3.1 General information
  • 5.3.2 Clinical trials specific information
• 5.4 Estonia
  • 5.4.1 General information
  • 5.4.2 Clinical trials specific information
• 5.5 Greece
  • 5.5.1 General information
  • 5.5.2 Clinical trials specific information
• 5.6 Hungary
  • 5.6.1 General information
  • 5.6.2 Clinical trials specific information
• 5.7 Latvia
  • 5.7.1 General information
  • 5.7.2 Clinical trials specific information
• 5.8 Lithuania
  • 5.8.1 General information
  • 5.8.2 Clinical trials specific information
• 5.9 Poland
  • 5.9.1 General information
  • 5.9.2 Clinical trials specific information
• 5.10 Romania
  • 5.10.1 General information
  • 5.10.2 Clinical trials specific information
• 5.11 Russia
  • 5.11.1 General information
  • 5.11.2 Clinical trials specific information
• 5.12 Serbia
  • 5.12.1 General information
  • 5.12.2 Clinical trials specific information
• 5.13 Slovak Republic
  • 5.13.1 General information
  • 5.13.2 Clinical trials specific information
• 5.14 Slovenia
  • 5.14.1 General information
  • 5.14.2 Clinical trials specific information
• 5.15 Turkey
  • 5.15.1 General information
  • 5.15.2 Clinical trials specific information
• 5.16 Ukraine
  • 5.16.1 General information
  • 5.16.2 Clinical trials specific information
• 5.17 Clinical trial activity: CEE countries
• 5.18 Summary for region

• 6.1 Argentina
  • 6.1.1 General information
  • 6.1.2 Clinical trials specific information
• 6.2 Brazil
  • 6.2.1 General information
  • 6.2.2 Clinical trials specific information
• 6.3 Chile
  • 6.3.1 General information
  • 6.3.2 Clinical trials specific information
• 6.4 Colombia
  • 6.4.1 General information
  • 6.4.2 Clinical trials specific information
• 6.5 Costa Rica
  • 6.5.1 General information
  • 6.5.2 Clinical trials specific information
• 6.6 Mexico
  • 6.6.1 General information
  • 6.6.2 Clinical trials specific information
• 6.7 Panama
  • 6.7.1 General information
  • 6.7.2 Clinical trials specific information
• 6.8 Peru
  • 6.8.1 General information
  • 6.8.2 Clinical trials specific information
• 6.9 Puerto Rico
  • 6.9.1 General information
  • 6.9.2 Clinical trials specific information
• 6.10 Uruguay
  • 6.10.1 General information
  • 6.10.2 Clinical trials specific information
• 6.11 Venezuela
  • 6.11.1 General information
  • 6.11.2 Clinical trials specific information
• 6.12 Clinical trials activity: Latin America
• 6.13 Summary for region

• 7.1 Israel
  • 7.1.1 General information
  • 7.1.2 Clinical trials specific information
• 7.2 Clinical trial activity: Middle East
• 7.3 Summary for region

• 8.1 Egypt
  • 8.1.1 General information
  • 8.1.2 Clinical trials specific information
• 8.2 South Africa
  • 8.2.1 General information
  • 8.2.2 Clinical trials specific information
• 8.3 Uganda
  • 8.3.1 General informationclvi
  • 8.3.2 Clinical trials specific information
• 8.4 Clinical trial activity: Africa
• 8.5 Summary for region

ANNEX I

REFERENCES

• Table 1.1: List of countries considered for inclusion in this report
• Table 2.1: India: Country population statistics
• Table 2.2: Number of government allopathic hospitals and hospital beds in rural and urban areas (including CHCs)vii
• Table 2.3: Total government allopathic hospitals (including CHCs) and beds and ratio to populationviii
• Table 2.4: India: Country healthcare statistics
• Table 2.5: Regulatory agency and other websites for India
• Table 2.6: Requirements for filing applications for global clinical trials
• Table 2.7: India: US FDA audit results
• Table 2.8: Indian population groups
• Table 2.9: Top ten commercial sponsors of clinical trials in India
• Table 2.10: Top ten disease areas subject to clinical trials in India
• Table 3.1: Regulatory agency and other websites for China
• Table 3.2: China: US FDA audit results
• Table 3.3: Top ten commercial sponsors of clinical trials in China
• Table 3.4: Top ten disease areas being studied in China
• Table 4.1: SE Asia: Country population statistics
• Table 4.2: SE Asia: Country healthcare statistics
• Table 4.3: SE Asia: US FDA audit results
• Table 4.4: Regulatory agency and other websites for Hong Kong
• Table 4.5: South Korea: Country population statistics
• Table 4.6: South Korea: Country healthcare statistics
• Table 4.7: Regulatory agency and other websites for South Korea
• Table 4.8: Malaysia: Country population statistics
• Table 4.9: Malaysia: Country healthcare statistics
• Table 4.10: Regulatory agency and other websites for Malaysia
• Table 4.11: Philippines: Country population statistics
• Table 4.12: Philippines: Country healthcare statistics
• Table 4.13: Regulatory agency and other websites for Philippines
• Table 4.14: Singapore: Country population statistics
• Table 4.15: Singapore: Country healthcare statistics
• Table 4.16: Regulatory agency and other websites for Singapore
• Table 4.17: Taiwan: Country population statistics
• Table 4.18: Regulatory agency and other websites for Taiwan
• Table 4.19: Thailand: Country population statistics
• Table 4.20: Thailand: Country healthcare statistics
• Table 4.21: Regulatory agency and other websites for Thailand
• Table 4.22: Top ten commercial sponsors of clinical trials in SE Asia
• Table 4.23: Top ten diseases subject to clinical trials in SE Asia
• Table 4.24: Top ten diseases subject to clinical trials in Hong Kong
• Table 4.25: Total study numbers and US FDA audit results for SE Asia
• Table 4.26: Population and study numbers Selected countries
• Table 5.1: CEE: Country population statistics
• Table 5.2: CEE: Country healthcare statistics
• Table 5.3: Top eight countries in CEE for clinical trials according to ClinicalTrials.gov
• Table 5.4: CEE: US FDA audit results
• Table 5.5: Bulgaria: Country population statistics
• Table 5.6: Bulgaria: Country healthcare statistics
• Table 5.7: Regulatory agency and other websites for Bulgaria
• Table 5.8: Croatia: Country population statistics
• Table 5.9: Croatia: Country healthcare statistics
• Table 5.10: Regulatory agency and other websites for Croatia
• Table 5.11: Czech Republic: Country population statistics
• Table 5.12: Czech Republic: Country healthcare statistics
• Table 5.13: Regulatory Agency and other Websites for the Czech Republic
• Table 5.14: Estonia: Country population statistics
• Table 5.15: Estonia: Country healthcare statistics
• Table 5.16: Regulatory agency and other websites for Estonia
• Table 5.17: Greece: Country population statistics
• Table 5.18: Greece: Country healthcare statistics
• Table 5.19: Regulatory agency and other websites for Greece
• Table 5.20: Hungary: Country population statistics
• Table 5.21: Hungary: Country healthcare statistics
• Table 5.22: Regulatory agency and other websites for Hungary
• Table 5.23: Latvia: Country population statistics
• Table 5.24: Latvia: Country healthcare statistics
• Table 5.25: Regulatory agency and other websites for Latvia
• Table 5.26: Lithuania: Country population statistics
• Table 5.27: Lithuania: Country healthcare statistics
• Table 5.28: Regulatory agency and other websites for Lithuania
• Table 5.29: Poland: Country population statistics
• Table 5.30: Poland: Country healthcare statistics
• Table 5.31: Regulatory agency and other websites for Poland
• Table 5.32: Romania: Country population statistics
• Table 5.33: Romania: Country healthcare statistics
• Table 5.34: Regulatory agency and other websites for Romania
• Table 5.35: Russia: Country population statistics
• Table 5.36: Russia: Country healthcare statistics
• Table 5.37: Regulatory agency and other websites for Russia
• Table 5.38: Serbia: Country population statistics
• Table 5.39: Serbia: Country healthcare statistics
• Table 5.40: Regulatory agency and other websites for Serbia
• Table 5.41: Slovakia: Country population statistics
• Table 5.42: Slovakia: Country healthcare statistics
• Table 5.43: Regulatory agency and other websites for Slovakia
• Table 5.44: Slovenia: Country population statistics
• Table 5.45: Slovenia: Country healthcare statistics
• Table 5.46: Regulatory agency and other websites for Slovenia
• Table 5.47: Slovenia: US FDA audit results
• Table 5.48: Turkey: Country population statistics
• Table 5.49: Turkey: Country healthcare statistics
• Table 5.50: Regulatory agency and other websites for Turkey
• Table 5.51: Ukraine: Country population statistics
• Table 5.52: Ukraine: Country healthcare statistics
• Table 5.53: Regulatory Agency and other websites for Ukraine
• Table 5.54: Top ten commercial sponsors of clinical trials in CEE
• Table 5.55: Top ten diseases subject to clinical trials in CEE
• Table 6.1: Latin America: Country population statistics
• Table 6.2: Latin America: Country healthcare statistics
• Table 6.3: Agencies for region Latin America
• Table 6.4: Argentina: Country population statistics
• Table 6.5: Argentina: Country healthcare statistics
• Table 6.6: Regulatory agency and other websites for Argentina
• Table 6.7: Brazil: Country population statistics
• Table 6.8: Capacity of the Brazilian health sector, 1992
• Table 6.9: Brazil: Country healthcare statistics
• Table 6.10: Regulatory agency and other websites for Brazil
• Table 6.11: Chile: Country population statistics
• Table 6.12: Chile: Country healthcare statistics
• Table 6.13: Regulatory agency and other websites for Chile
• Table 6.14: Latin America: Country healthcare statistics
• Table 6.15: Regulatory agency and other websites for Columbia
• Table 6.16: Costa Rica: Country population statistics
• Table 6.17: Costa Rica: Country healthcare statistics
• Table 6.18: Regulatory agency and other websites for Costa Rica
• Table 6.19: Mexico: Country population statistics
• Table 6.20: Mexico: Country healthcare statistics
• Table 6.21: Regulatory agency and other websites for Mexico
• Table 6.22: Panama: Country population statistics
• Table 6.23: Panama: Country healthcare statistics
• Table 6.24: Regulatory agency and other websites for Panama
• Table 6.25: Peru: Country population statistics
• Table 6.26: Peru: Country healthcare statistics
• Table 6.27: Regulatory agency and other websites for Peru
• Table 6.28: Puerto Rico: Country population Statistics
• Table 6.29: Regulatory agency and other websites for Puerto Rico
• Table 6.30: Uruguay: Country population statistics
• Table 6.31: Uruguay: Country healthcare statistics
• Table 6.32: Regulatory agency and other websites for Uruguay
• Table 6.33: Venezuela: Country population statistics
• Table 6.34: Venezuela: Country healthcare statistics
• Table 6.35: Regulatory agency and other websites for Venezuela
• Table 6.36: Top ten commercial sponsors of clinical trials in Latin America
• Table 6.37: Top ten disease areas subject to clinical trials in Latin America
• Table 6.38: Total study numbers and US FDA audit results for Latin America
• Table 6.39: Countries with US FDA audit results showing official action indicated (OAI)
• Table 6.40: Top 20 countries (in this report) for ClinicalTrials.gov
• Table 7.1: Middle East: Country population statistics
• Table 7.2: Middle East: Country healthcare statistics
• Table 7.3: Middle East US FDA audit results
• Table 7.4: Israel: Country population statistics
• Table 7.5: Israel: Country healthcare statistics
• Table 7.6: Israel' s healthcare infrastructure 2002
• Table 7.7: Regulatory agency and other websites for Israel
• Table 7.8: Top ten commercial sponsors of clinical trials in Israel
• Table 7.9: Top ten disease areas subject to clinical trials in Israel
• Table 7.10: Top clinical trials destinations for this report, plus selected other countries, per ClinicalTrials.gov
• Table 7.11: Israel compared with selected other Middle Eastern countries
• Table 8.1: Africa: Country population statistics
• Table 8.2: Africa: Country healthcare statistics
• Table 8.3: Africa: US FDA audit results
• Table 8.4: Egypt: Country population statistics
• Table 8.5: Egypt: Country healthcare statistics
• Table 8.6: Regulatory agency and other websites for Egypt
• Table 8.7: South Africa: Country population statistics
• Table 8.8: South Africa: Country healthcare statistics
• Table 8.9: Regulatory agency and other websites for South Africa
• Table 8.10: Uganda: Country population statistics
• Table 8.11: Uganda: Country healthcare statistics
• Table 8.12: Regulatory agency and other websites for Uganda
• Table 8.13: Top ten pharmaceutical company sponsors of clinical trials in South Africa
• Table 8.14: Top ten disease areas subject to clinical trials in South Africa
• Table 9.1: Top countries participating in new FDA-regulated trials in 2006
• Table 9.2: Labour costs for selected emerging countries1
• Table 9.3: Sponsors of clinical trials in India
• Table 9.4: Disease areas being studied in Indian trials
• Table 9.5: Sponsors of ongoing clinical trials in China
• Table 9.6: Disease areas being studied in China

• Figure 3.1: SFDA organisation chart, abridgedxxvii
• Figure 3.2: Application and approval procedure for clinical trials xxxiii