Research and Markets: Orphan Drugs in Asia 2014-2015
Research and Markets has announced the addition of the "Orphan Drugs in Asia 2014" report to their offering.
Following the example of the 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 laws on orphan drugs 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.
The 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 2014 include
• Recent 2014 government approval list for orphan drugs in Taiwan
• Updated application forms and requirements in Japan, Taiwan, Korea, Hong Kong and China
• Latest registration policies and regulations on orphan drugs in Asia
• New information involving priority review and regulations in Asia
• Recent data involving orphan drugs market in Asian countries
• 2014 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.
Key Topics Covered:
I. Introduction
II. Overview of Asia
III. Orphan Drugs in Asia
IV. Issues to Consider Prior to Orphan Drug Registration
V. Japan
VI. Taiwan
VII. Korea
VIII. Hong Kong
IX. China
X. Singapore
XI. Southeast Asia Introduction
XII. Philippines
XIII. Malaysia
XIV. Thailand
XV. Vietnam
XVI. Sales and Marketing of Orphan Drugs in Asia
XVII. Conclusion
Related News
-
News Eli Lilly gets ready to launch five new drugs in 2023
Eli Lilly, the American pharmaceutical company (IN, USA) are gearing up for a big year ahead, with hopes to launch five new drugs and capitalise on growing obesity and Alzheimer’s disease markets. -
News Amgen buys Horizon for $27.8 billion in bold step into the rare disease market
Amgen Inc buys pharmaceutical company Horizon Therapeutics in a multibillion-dollar deal, in hopes to capitalise on it's portfolio of drugs in the highly sort after rare disease market. -
News Pharma Supply Chain People Moves
The latest appointments and promotions across the pharmaceutical supply chain. -
News Merck to donate new Ebola vaccine to defend against outbreaks in Uganda
Pharmaceutical giant Merck has announced they will be speeding up the processing of a new vaccine against the latest strain of the Ebola virus, to be donated to a global non-profit organisation for distribution -
News CPHI Podcast Series: Driving innovation with pharmaceutical startups
The latest episode in the CPHI Podcast Series explores how startups are driving innovation by taking high-risk approaches and doing business with greater agility. -
News Greener and efficient processes: Quaternary Ammonium Salts
Quaternary Ammonium Salts play a crucial part in Organic Chemistry processes at many major industries. Discover why.
-
News Biosimilars save patients $11B annually, but barriers to adoption remain in US market
Biosimilars introduce competition into the biologics market, driving down prices and increasing patient access. -
News WHO recommends use of two monoclonal antibody treatments against Ebola
The health body recommended use of treatments by Regeneron and Ridgeback Bio
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance