2010 Taiwan Drug Registration and Regulatory Issues

June 9, 2010

Taiwan is a major market for pharmaceuticals in Asia. It is among the wealthier Asian countries and boasts a solid national health care system. This webcast will delve into the various regulatory issues and requirements for Taiwan drug registration. The types of drugs this presentation will cover include Western drugs, over the counter, and generic products. This will be a live webcast with the presenter speaking from Taiwan. The speaker is Pacific Bridge Medical's Taiwanese partner who has over 20 years of experience in the pharmaceutical industry in Asia and Taiwan. There will be a 60-minute presentation followed by a 30-minute Q&A session.

See a sample page of our webcast presentation.

  • Introduction to Taiwan
  • Taiwan Health System: How does it work?
  • Overview of Taiwan drug registration for
    • Class I New Drug
      • New Chemical Entity
      • New Administrative Route
      • New Combination
      • New Therapeutic Indication
    • Class II New Drug
      • New Dosage Form (Immediate Release)
      • Controlled Release Product
      • Transdermal Product
      • New Usage Dose
      • New Strength
    • Generic Drug
    • OTC
  • Required documents for product approval of
    • Class I New Drug
      • New Chemical Entity
      • New Administrative Route
      • New Combination
      • New Therapeutic Indication
    • Class II New Drug
      • New Dosage Form (immediate Release)
      • Controlled Release Product
      • Transdermal Product
      • New Usage Dose
      • New Strength
    • Generic Drug
    • OTC
  • Testing requirements
  • Clinical trials requirements
  • Flow chart of registration process
  • Key factors for success in Taiwan drug registration
  • Pitfalls to avoid in registering drugs in Taiwan
  • Adverse events
  • Other key issues

This webcast CD includes the audio and PowerPoint presentation.


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