May 30 2007, 1:00 AM EST
News source: Business Wire
Research and Markets (http://www.researchandmarkets.com/reports/c58292) has announced the addition of "Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2007" to their offering.
Following the example of the US FDA's Orphan Drug Act established in 1983, some Asian nations have developed orphan drug legislation, 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 throughout Asia and discusses various business issues related to orphan drugs in Asia. Lists of approved orphan drugs in Asia and orphan drug associations are also included.
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 XVII. Conclusion
Companies Mentioned
- Actelion Pharmaceuticals - Amgen - Astellas Pharma US - Axcan Scandipharm - Bausch & Lomb - Baxter - Bayer - Biogen IDEC - BioMarin - Boehringer Ingelheim - Bristol-Myers Squibb - Celgene - Centocor - ChiRhoClin - CoTherix - Cumberland Pharmaceuticals - Dialysis Solutions - DynPort Vaccine - Eli Lilly - EMD Pharmaceuticals - Farmacon-IL - Genzyme - GlaxoSmithKline - Guilford Pharmaceuticals - Heyl Chemisch-Pharmzeutische Fabrik - ImClone - Insmed - Jazz Pharmaceuticals - Mayne Pharma - Medicis - Merck - MGI CP - Millennium Pharmaceuticals - Mylan Bertek Pharmaceuticals - Novartis - Novo Nordisk - Nutritional Restart Pharmaceutical Hameln - Orphan Medical, Inc. - Pharmaceuticals - Pharmion - Presutti Laboratories - PTC Therapeutics - Reckitt Benckiser Pharmaceuticals, Inc. - Romark Laboratories - Salix Pharmaceuticals - Sanofi-Synthelabo Research- Schering-Plough - Sensus - Serono Laboratories - Shire Human Genetic Therapies - Swedish Orphan AB - Tercica - United Therapeutics - Yamanouchi - Fujisawa - Tsumura - Fujisawa - Mitsubishi Pharmaceutical - Shionogi - Banyu Pharmaceutical Chugai
For more information visit http://www.researchandmarkets.com/reports/c58292
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