This CPD module entitled “Understanding Generic Medicines: What Healthcare Professionals Should Know” is published to create awareness among healthcare professionals on the issues surrounding the prescribing and utilization of generic medicines. The learning outcomes of this module are:

  • To describe the terms “generic medicine” and “bioavailability” and to become familiar with concepts
    related to “bioequivalence testing”   
     
  • To describe the generic medicines registration process in Malaysia   
     
  • To expose healthcare professionals to the concept of quality use of generic medicines 
     

List of Authors

Universiti Sains Malaysia

Associate Professor Dr. Mohamed Azmi Hassali
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

Dr. Jayabalan Thambyappa
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

Professor Yuen Kah Hay
Discipline of Pharmaceutical Technology, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

Ms. Gin Nie Chua
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

Mr. Fahad Saleem
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

Associate Professor Dr. Asrul Shafie
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

International Medical University

Professor Michael John Rathbone
School of Pharmacy, International Medical University, Kuala Lumpur, Malaysia

Ministry of Health, Malaysia

Dr. Salmah Bahri
Pharmaceutical Service Division, Ministry of Health, Malaysia

Mr. Dziehan Mustapha
Pharmaceutical Service Division, Ministry of Health, Malaysia

Table of Contents

  • List of Authors
  • Preface (page 2)
  • Introduction (page 3-4)
  • Registration of generic medicines in Malaysia (page 4-6)
  • Quality, efficacy and safety of generic medicines (page 6-10)
  • Points to consider in brand switching (page 10 -11)
    • Welcoming
    • Questions
    • Listening
    • Response
    • Explanation
    • Closure
  • Conclusion (page 12)
  • Assessment Questions – use our online quiz
  • References (page15-16)

The authors acknowledge the following individuals involved in the publication of the module:

  • Mr Lean Ka-Min
    Publications Officer, Third World Network, Penang, Malaysia 
     
  • Ms. Mazuwin Zainal Abidin
    Senior Principal Assistant Director
    Generic Drugs Sub Section, Centre for Product Registration
    National Pharmaceutical Control Bureau, Ministry of Health, Malaysia 
     
  • Ms. Lee Shi Wei
    MSc Candidate
    Discipline of Social and Administrative Pharmacy
    School of Pharmaceutical Sciences, Univeristy Sains Malaysia, Penang, Malaysia  

 

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