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

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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)

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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