新興国市場における臨床試験の実施

This report is intended for those engaged in pharmaceutical clinical trials from all different areas of the industry who are interested in starting or expanding their clinical trials activity in emerging markets. The introduction begins with a definition of which countries and regions will be addressed and discusses the general reasons why companies are conducting trials in these countries.

Those familiar with some or all of the regions will immediately recognise that some countries included in this report are not ' emerging' . However, a significant number of people would regard any one of the countries in this report as emerging and therefore they have been included.

As there is a potentially very large body of information about emerging markets, the introduction also covers which types of information are included and which have had to be left out. Finally, there is an explanation of the standard country tables that are repeated throughout the report. Emerging countries tend to be highly similar in regard to patient recruitment drivers, investigator site staff training and partner selection. This is even more the case at the regional level for some areas. Therefore, even those only interested in a single country are recommended to read the report introduction and regional CHAPTER opening. These give general information concerning all countries and a discussion on the information content to each country.

The countries are then discussed by regional chapter. Each country has a section describing the healthcare system and a section concerning the specifics of conducting clinical trials, followed by a section on current clinical trial activity. The amount of information on each country depends on the relative importance of the country to the sector and the amount of information that is available. For some regions where there is a high degree of homogeneity, more information is given at the regional level at the start of the chapter. For most countries, there is a divide between the official regulatory information and practical aspects of conducting clinical trials.

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