Postapproval Changes for Drugs: A Practical Guide
iii
Table of Contents
Foreword. .................................................................................................................................................vii
Preface. .......................................................................................................................................................ix
Author Acknowledgments.........................................................................................................................xi
Section I: Marketing Authorization Transfers, Renewals, and Administrative Changes. ...................1
Chapter 1: United States......................................................................................................................... 3
By Melodi McNeil, RPh, MS
Chapter 2: Argentina, Brazil, Canada, Chile, and Mexico .....................................................................7
By Shakti Tripathy, MPharm
Chapter 3: European Union, United Kingdom, and Switzerland. ........................................................15
By Pallavi Trivedi, MPH, RAC-US
Chapter 4: Australia, New Zealand, Malaysia, and Singapore. .............................................................27
By Judy Bingham, MHA
Chapter 5: Middle East North Africa................................................................................................... 39
By Hakima Hoseh, RAC-Drugs
Section II: Quality/Chemistry, Manufacturing, and Control Changes........................................... 55
Chapter 6: Argentina, Brazil, Canada, Chile, Mexico, and United States. ............................................57
By Moonmoon Mishra, MPharm and Blaine Van Leuven, MS, RAC
Chapter 7: European Union, United Kingdom, and Switzerland. ........................................................77
By Karin McIntosh, MPharm, RAC-Drugs and Moonmoon Mishra, MPharm
Chapter 8: Australia, New Zealand, Malaysia, and Singapore. .............................................................91
By Judy Bingham, MHA
Chapter 9: Japan. ................................................................................................................................103
By Seema Singh, MSc and Linda McBride, RPh, RAC-US
iii
Table of Contents
Foreword. .................................................................................................................................................vii
Preface. .......................................................................................................................................................ix
Author Acknowledgments.........................................................................................................................xi
Section I: Marketing Authorization Transfers, Renewals, and Administrative Changes. ...................1
Chapter 1: United States......................................................................................................................... 3
By Melodi McNeil, RPh, MS
Chapter 2: Argentina, Brazil, Canada, Chile, and Mexico .....................................................................7
By Shakti Tripathy, MPharm
Chapter 3: European Union, United Kingdom, and Switzerland. ........................................................15
By Pallavi Trivedi, MPH, RAC-US
Chapter 4: Australia, New Zealand, Malaysia, and Singapore. .............................................................27
By Judy Bingham, MHA
Chapter 5: Middle East North Africa................................................................................................... 39
By Hakima Hoseh, RAC-Drugs
Section II: Quality/Chemistry, Manufacturing, and Control Changes........................................... 55
Chapter 6: Argentina, Brazil, Canada, Chile, Mexico, and United States. ............................................57
By Moonmoon Mishra, MPharm and Blaine Van Leuven, MS, RAC
Chapter 7: European Union, United Kingdom, and Switzerland. ........................................................77
By Karin McIntosh, MPharm, RAC-Drugs and Moonmoon Mishra, MPharm
Chapter 8: Australia, New Zealand, Malaysia, and Singapore. .............................................................91
By Judy Bingham, MHA
Chapter 9: Japan. ................................................................................................................................103
By Seema Singh, MSc and Linda McBride, RPh, RAC-US