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Information Updates on Bioequivalence (BE) Webpage (June 2015)

Date: 06 July 2015

Description: The following information has been updated on Bioequivalence (BE) webpage. Please click on the links to find out more.

Bioequivalence Guideline

  • New ASEAN Guideline for "The Conduct of Bioequivalence Studies"


Generic Product List

  • 1st Generic Immediate Release Product List (June 2015)
  • 2nd Generic Immediate Release Product List (June 2015)
  • 3rd Generic Immediate Release Product List (June 2015)
  • 4th Generic Immediate Release Product List (June 2015)
  • 5th Generic Immediate Release Product List (June 2015)
  • 6th Generic Immediate Release Product List (June 2015)
  • 7th Generic Immediate Release Product List (June 2015)
  • 8th Generic Immediate Release Product List (June 2015)
  • 9th Generic Immediate Release Product List (June 2015)
  • The Implementation on Antiretroviral (ARV) Drug (June 2015)
  • List of Comparator Products For Bioequivalence Studies (June 2015)
  • List of Comparator Products For Fixed Dose Combination (June 2015)
  • List of Comparator Products in Dosage Forms of Effervescents, Dispersible, Orodispersible, Sublingual, Lozenges, Buccal and Chewable Tablets/Capsules


Biowaivers

  • Biopharmaceutics Classification System(BCS) - Based Biowaiver (List A)
  • Biowaivers granted based on unavailability/ inaccessibility of comparator/innovator product (List B)

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