Postapproval Changes for Drugs: A Practical Guide
iv
Section III: Safety and Product Information-Related Changes.....................................................109
Chapter 10: Argentina, Brazil, Canada, Chile, Mexico, and United States. ..........................................111
By Kathrin Schalper, PhD, RAC-US, RAC-EU, RAC-CAN, RAC-Devices
Chapter 11: European Union, United Kingdom, and Switzerland. ......................................................123
By Julie Watchorn, MSc, RAC-EU, and Linda McBride, RPh, RAC-US
Chapter 12: China. ...............................................................................................................................141
By Yingying Liu, MSc
Chapter 13: Middle East North Africa ................................................................................................147
By Hadeer Abdulbasir Sayed
Chapter 14: Africa. ...............................................................................................................................159
By Hadeer Abdulbasir Sayed
Section IV: Postauthorization Commitments and Studies. ...........................................................173
Chapter 15: Argentina, Brazil, Canada, Chile, Mexico, and United States. ..........................................175
By Jing Zhou, MS and Juliane Carvalho, MS, RAC-Drugs
Chapter 16: European Union, United Kingdom, and Switzerland. ......................................................197
By Karin McIntosh, MPharm, RAC-Drugs
Chapter 17: China. ...............................................................................................................................203
By Murphy Mao, MSc, Yingying Liu, MSc, and Hongbo Pan, MBA
Chapter 18: Middle East North Africa................................................................................................. 209
By Fatima Zaid Abu Zanat, MSc, RPh, RAC-Drugs, RAC-Devices
Chapter 19: Africa. ...............................................................................................................................213
By Faustin Ndindayino, PhD
Section V: Postmarketing Surveillance and Risk Management. ....................................................221
Chapter 20: Argentina, Brazil, Canada, Chile, Mexico, and United States. ..........................................223
By Dachelle Johnson, PharmD, RAC-US
Chapter 21: European Union, United Kingdom, and Switzerland. ......................................................237
By Julie Watchorn, MSc, RAC-EU and Pallavi Trivedi, MPH, RAC-US
Chapter 22: Africa. ...............................................................................................................................249
By Faustin Ndindayino, PhD
Figures
Figure 5-1. Summary of MAH Class Changes and Approval Times in MENA Countries. ................43
Figure 6-1. Comparison of Change Details and Document Requirements in the US and Canada
Postapproval Guideline. ......................................................................................................62
Figure 9-1. PMDA Consultation Flow for PACMP Quality Consultation........................................ 105
iv
Section III: Safety and Product Information-Related Changes.....................................................109
Chapter 10: Argentina, Brazil, Canada, Chile, Mexico, and United States. ..........................................111
By Kathrin Schalper, PhD, RAC-US, RAC-EU, RAC-CAN, RAC-Devices
Chapter 11: European Union, United Kingdom, and Switzerland. ......................................................123
By Julie Watchorn, MSc, RAC-EU, and Linda McBride, RPh, RAC-US
Chapter 12: China. ...............................................................................................................................141
By Yingying Liu, MSc
Chapter 13: Middle East North Africa ................................................................................................147
By Hadeer Abdulbasir Sayed
Chapter 14: Africa. ...............................................................................................................................159
By Hadeer Abdulbasir Sayed
Section IV: Postauthorization Commitments and Studies. ...........................................................173
Chapter 15: Argentina, Brazil, Canada, Chile, Mexico, and United States. ..........................................175
By Jing Zhou, MS and Juliane Carvalho, MS, RAC-Drugs
Chapter 16: European Union, United Kingdom, and Switzerland. ......................................................197
By Karin McIntosh, MPharm, RAC-Drugs
Chapter 17: China. ...............................................................................................................................203
By Murphy Mao, MSc, Yingying Liu, MSc, and Hongbo Pan, MBA
Chapter 18: Middle East North Africa................................................................................................. 209
By Fatima Zaid Abu Zanat, MSc, RPh, RAC-Drugs, RAC-Devices
Chapter 19: Africa. ...............................................................................................................................213
By Faustin Ndindayino, PhD
Section V: Postmarketing Surveillance and Risk Management. ....................................................221
Chapter 20: Argentina, Brazil, Canada, Chile, Mexico, and United States. ..........................................223
By Dachelle Johnson, PharmD, RAC-US
Chapter 21: European Union, United Kingdom, and Switzerland. ......................................................237
By Julie Watchorn, MSc, RAC-EU and Pallavi Trivedi, MPH, RAC-US
Chapter 22: Africa. ...............................................................................................................................249
By Faustin Ndindayino, PhD
Figures
Figure 5-1. Summary of MAH Class Changes and Approval Times in MENA Countries. ................43
Figure 6-1. Comparison of Change Details and Document Requirements in the US and Canada
Postapproval Guideline. ......................................................................................................62
Figure 9-1. PMDA Consultation Flow for PACMP Quality Consultation........................................ 105