2013 || Aarkstore.in || Orphan Drugs in Asia-Pacific: From Designation to Pricing

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Report
2013 Orphan Drugs in Asia-Pacific From
Designation to Pricing Aarkstore.in
http//aarkstore.in/Orphan-Drugs-in-Asia-Pacifi
c-Designation-to-Pricing.html
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Summary

• A major new report Orphan Drugs in
  Asia-Pacific From designation to pricing,
  funding and market access focuses on five
  developed markets in the region Japan, South
  Korea, Taiwan, Singapore and Australia. Each has
  passed specific measures to promote the
  development, registration and/or
  commercialisation of rare disease treatments.
  Singapores Medicines (Orphan Drug) Exemption
  Order of 1991 was the first legislation anywhere
  to follow the US Orphan Drug Act, with the other
  four Asia-Pacific countries also implementing
  orphan-promoting measures ahead of the EU.
  More

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Table of Contents

• 1. Introduction  2. Japan  2.1
  Healthcare and Health Insurance System  2.2
  Orphan Drug Legislation  2.2.1 Orphan Drug
  Development Programme, 1993  2.2.2 Qualifying
  Criteria  2.2.3 Procedure/Timetable  2.2.4
  Incentives  2.2.4.1 RD Support  2.2.4.2
  Protocol Assistance  2.2.4.3 Expedited
  Regulatory Review  2.2.4.4 Lower Regulatory Fees
   2.2.4.5 Market Exclusivity
  More

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