Navigation Links
Reportlinker Adds Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2011
Date:4/27/2011

NEW YORK, April 27, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2011

http://www.reportlinker.com/p0486821/Orphan-Drugs-in-Asia-Guidelines-and-Regulatory-Requirements-to-Help-Orphan-Drug-Products-Enter-the-Asian-Market-2011.html

Overview:

Following the example of the US FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislations, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law.

While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety of challenges.

This report reviews the orphan drug regulations in 10 Asian countries and discusses various business issues related to orphan drugs in the region. Lists of approved orphan drugs in Japan and Korea as well as a list of orphan drug associations are also included.

Updates for 2011 include:

• Recent 2011 government approval list for orphans drugs in the US and Japan

• Recent issues surrounding rare disease treatment in 10 Asian countries

• Latest orphan drug registration policies and regulations in Asia

This report is 109 pages.

TABLE OF CONTENTS

I. Introduction 

A. Global Outlook on rare diseases

B. Development of Orphan Drug Legislation

C. Well-Known Rare Diseases

D. US FDA Contact Information

E. US Orphan Drug Associations

F. US FDA Orphan Drug Approvals

II. Overview of Asia 

A. The Asian Economy

B. The Pharmaceutical Markets in Asia

III. Orphan Drugs in Asia 

A. Do orphan drugs have potential in Asia?

B. Why seek orphan drug status?

IV. Issues to Consider Prior to Orphan Drug Registration 

A. Introduction

B. Are treatment options already available in the country?

C. Is your drug superior to those already on the market?

D. Conclusion

V. Japan 

A. Introduction

B. Ministry of Health, Labor and Welfare

C. Pharmaceuticals and Medical Devices Agency

D. Orphan Drugs in Japan

E. Health Authority Contact Information

F. Orphan Drug Associations

G. Orphan Drugs Approved in Japan

H. Orphan Drugs Designated in Japan

VI. Taiwan 

A. Overview

B. Taiwanese Health Authorities

C. Health Insurance Scheme

D. Orphan Drugs in Taiwan

E. Health Authority Contact Information

F. Orphan Drug Associations

VII. Korea 

A. Overview

B. Drug Registration Overview

C. Orphan Drugs in Korea

D. Health Authority Contact Information

E. Orphan Drug Associations

F. Orphan Drugs Approved in Korea

VIII. Hong Kong 

A. Overview

B. Hong Kong Health Authority

C. Orphan Drugs In Hong Kong

D. Health Authority Contact Information

IX. China 

A. Overview

B. Pharmaceutical Market

C. China Health Authority

D. Drug Registration Process

E. Drug Pricing

F. Orphan Drugs in China

G. Health Authority Contact Information

X. Singapore 

A. Overview

B. Singapore Health Authority

C. Orphan Drug Definition and Legislation

D. Health Authority Contact Information

XI. Southeast Asia Introduction 

A. Overview

B. Drug Registration Requirements for Southeast Asia

XII. Philippines 

A. Overview

B. Philippines Health Authority

C. Orphan Drug Registration Process

D. Health Authority Contact Information

XIII. Malaysia 

A. Overview

B. Malaysia Health Authority

C. Drug Registration Overview

D. Health Authority Contact Information

XIV. Thailand 

A. Overview

B. Drug Registration Overview

C. Orphan Drug Summary

D. Health Authority Contact Information

XV. Vietnam 

A. Overview

B. Drug Registration Overview

C. Health Authority Contact Information

D. Orphan Drug Associations

XVI. Sales and Marketing of Orphan Drugs 

A. Introduction

B. Preparing a Sales Forecast

C. In-country Support

D. Distribution

XVII. Conclusion

To order this report:

: Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2011

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg

Reportlinker

Email: nbo@reportlinker.com

US: (805)652-2626

Intl: +1 805-652-2626


'/>"/>
SOURCE Reportlinker
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Reportlinker Adds Epidemiology: Sepsis
2. Reportlinker Adds Cancer Vaccines Markets
3. Reportlinker Adds Pharmaceutical Key Trends 2011 - Pharmaceutical Industry Infrastructure Overview: Pharma innovates, diversifies and contains cost in order to grow profits
4. Reportlinker Adds Epidemiology: Rheumatoid Arthritis
5. Reportlinker Adds Epidemiology: Multiple Sclerosis
6. Reportlinker Adds Epidemiology: Lupus
7. Reportlinker Adds Epidemiology: Prostate Cancer
8. Reportlinker Adds Medical Equipment Monthly Deals Analysis - M&A and Investment Trends, April 2011
9. Reportlinker Adds Body Contouring Devices - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017
10. Reportlinker Adds Ophthalmology DrugFutures
11. Reportlinker Adds Europe ENT Devices Market Outlook to 2017
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Calif. , Feb. 4, 2016  Edwards Lifesciences ... patient-focused innovations for structural heart disease and critical care ... accelerated share repurchase (ASR) agreement with Morgan Stanley & ... stock.  This repurchase is part of the Company,s previously ... the Company,s common stock.  --> ...
(Date:2/4/2016)... , Feb. 4, 2016 Wegener ... Global Markets Direct,s, ,Wegener Polyangiitis - Pipeline ... Wegener Polyangiitis,s therapeutic pipeline. This report provides ... Polyangiitis, complete with comparative analysis at various stages, ... (MoA), route of administration (RoA) and molecule type, ...
(Date:2/4/2016)... 2016  Omnicell, Inc. (NASDAQ: OMCL ), a leading ... systems, today announced results for its fiscal year and ... --> GAAP results: Revenue for the ... million or 4.1% from the third quarter of 2015, ... quarter of 2014. Revenue for the year ended December 31, ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 05, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Tasting Event at the La Gorce Country Club in Miami Beach on March ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Give ... allow users to search for and donate to Give To Cure’s campaign that is ... app that lets users make and share payments through a smart device. In 2015 ...
(Date:2/5/2016)... ... 2016 , ... Stuart Bentkover, MD, FACS is thrilled to announce ... most effective tattoo removal today, Dr. Bentkover is the only doctor in Central Massachusetts ... PicoSure has been approved by the Food and Drug Administration (FDA) as a safe ...
(Date:2/5/2016)... ... February 05, 2016 , ... California Mobile Kitchens ... debut of their latest mobile kitchen model, featuring customizable stainless steel interiors and ... commercial kitchens for use anywhere in the U.S. Many of their units can ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Susan ... Medicare San Luis Obispo users can expect to see in 2016. To view the ... most significant changes will directly impact many San Luis Obispo seniors who rely on ...
Breaking Medicine News(10 mins):