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Press Release

Orphan Drugs in Asia 2012

REPORTLINKER.COM
Posted on: 11 Apr 12

PR Newswire

NEW YORK, April 11, 2012

NEW YORK, April 11, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Orphan Drugs in Asia 2012

http://www.reportlinker.com/p0510901/Orphan-Drugs-in-Asia-2012.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

Historically, many drugs for rare diseases were developed to fulfill the needs of public health, rather than for drug companies' financial gain. Nevertheless, there is now a growing awareness of rare diseases by Asian governments and consumers. More available treatments of rare diseases via orphan drugs are also creating new business opportunities for medical companies.

Pacific Bridge Medical's new and updated Orphan Drugs In Asia 2012 is an invaluable regulatory guide to assist companies interested in expanding their orphan drug business in Asia.

Our report will help drug companies navigate through Asia's orphan drug markets. The report provides government guidelines and regulatory requirements for orphan drug product registrations in 10 Asian countries.

Updates for 2012 include:

• Recent 2012 government approval list for orphan drugs in Taiwan

• Updated application forms and requirements in Japan, Taiwan, Korea, Hong Kong and China

• Latest orphan drug registration policies and regulations in Asia

• New information involving priority review and regulations in Asia

• Recent data involving orphan drugs market in Asian countries

• 2012 updated fees for Orphan Drug application processes for Japan, China, Korea, and Hong Kong

• Updated contact information for government health agencies in each Asian country

TABLE OF CONTENTS

1. INTRODUCTION 1

1.1 GLOBAL OUTLOOK ON RARE DISEASES 1

1.2 DEVELOPMENT OF ORPHAN DRUG LEGISLATION 3

1.3 WELL-KNOWN RARE DISEASES 4

1.4 US FDA CONTACT INFORMATION 5

1.5 US ORPHAN DRUG ASSOCIATIONS 5

1.6 US FDA ORPHAN DRUG APPROVALS (JANUARY 2002 TO FEBRUARY 2011) 8

2. OVERVIEW OF ASIA 19

2.1 THE ASIAN ECONOMY 19

2.2 THE PHARMACEUTICAL MARKETS IN ASIA 20

3. ORPHAN DRUGS IN ASIA 21

3.1 DO ORPHAN DRUGS HAVE POTENTIAL IN ASIA? 21

3.2 WHY SEEK ORPHAN DRUG STATUS? 21

4. ISSUES TO CONSIDER PRIOR TO ORPHAN DRUG REGISTRATION 22

4.1 INTRODUCTION 22

4.2 ARE TREATMENT OPTIONS ALREADY AVAILABLE IN THE COUNTRY? 22

4.3 IS YOUR DRUG SUPERIOR TO THOSE ALREADY ON THE MARKET? 23

4.4 CONCLUSION 23

5. JAPAN 24

5.1 INTRODUCTION 24

5.2 MINISTRY OF HEALTH, LABOR AND WELFARE 24

5.3 PHARMACEUTICALS AND MEDICAL DEVICES AGENCY 24

5.4 ORPHAN DRUGS IN JAPAN 24

5.5 HEALTH AUTHORITY CONTACT INFORMATION 40

5.6 ORPHAN DRUG ASSOCIATIONS 42

5.7 ORPHAN DRUGS APPROVED IN JAPAN 43

5.8 ORPHAN DRUGS DESIGNATED (NOT YET APPROVED) IN JAPAN 57

6. TAIWAN 61

6.1 OVERVIEW 61

6.2 TAIWANESE HEALTH AUTHORITIES 61

6.3 HEALTH INSURANCE SCHEME 62

6.4 ORPHAN DRUGS IN TAIWAN 62

6.5 HEALTH AUTHORITY CONTACT INFORMATION 68

6.6 ORPHAN DRUG ASSOCIATIONS 69

7. KOREA 71

7.1 OVERVIEW 78

7.2 DRUG REGISTRATION OVERVIEW 78

7.3 ORPHAN DRUGS IN KOREA 79

7.4 HEALTH AUTHORITY CONTACT INFORMATION 81

7.5 ORPHAN DRUG ASSOCIATIONS 85

7.6 ORPHAN DRUGS APPROVED IN KOREA ERROR! BOOKMARK NOT DEFINED.

8. HONG KONG 102

8.1 OVERVIEW 102

8.2 HONG KONG HEALTH AUTHORITY 102

8.3 ORPHAN DRUGS IN HONG KONG 102

8.4 HEALTH AUTHORITY CONTACT INFORMATION 105

9. CHINA 108

9.1 OVERVIEW 108

9.2 PHARMACEUTICAL MARKET 108

9.3 CHINA HEALTH AUTHORITY 108

9.4 DRUG REGISTRATION PROCESS 109

9.5 DRUG PRICING 116

9.6 ORPHAN DRUGS IN CHINA 116

9.7 HEALTH AUTHORITY CONTACT INFORMATION 118

10. SINGAPORE 119

10.1 OVERVIEW 119

10.2 SINGAPORE HEALTH AUTHORITY 119

10.3 ORPHAN DRUG REGISTRATION 119

10.4 HEALTH AUTHORITY CONTACT INFORMATION 120

11. SOUTHEAST ASIA INTRODUCTION 120

11.1 OVERVIEW 120

11.2 DRUG REGISTRATION REQUIREMENTS FOR SOUTHEAST ASIA 121

12. PHILIPPINES 122

12.1 OVERVIEW 122

12.2 PHILIPPINE HEALTH AUTHORITY 122

12.3 ORPHAN DRUG REGISTRATION PROCESS 122

12.4 HEALTH AUTHORITY CONTACT INFORMATION 123

13. MALAYSIA 124

13.1 OVERVIEW 124

13.2 MALAYSIA HEALTH AUTHORITY 124

13.3 DRUG REGISTRATION OVERVIEW 124

13.4 HEALTH AUTHORITY CONTACT INFORMATION 126

14. THAILAND 127

14.1 OVERVIEW 127

14.2 DRUG REGISTRATION OVERVIEW 127

14.3 ORPHAN DRUG SUMMARY 128

14.4 HEALTH AUTHORITY CONTACT INFORMATION 128

15. VIETNAM 129

15.1 OVERVIEW 129

15.2 DRUG REGISTRATION OVERVIEW 129

15.3 HEALTH AUTHORITY CONTACT INFORMATION 130

15.4 ORPHAN DRUG ASSOCIATIONS 130

16. SALES AND MARKETING OF ORPHAN DRUGS 131

16.1 INTRODUCTION 131

16.2 PREPARING A SALES FORECAST 131

16.3 IN-COUNTRY SUPPORT 131

17. CONCLUSION 132

To order this report:

Drug and Medication Industry: Orphan Drugs in Asia 2012

More  Market Research Report

Check our  Industry Analysis and Insights

CONTACT:Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626

SOURCE Reportlinker

PR Newswire
http://www.prnewswire.com/

Last updated on: 11/04/2012

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