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Section I: Marketing Authorization Transfers, Renewals, and Administrative Changes Chapter 1: United States Chapter 2: Argentina, Brazil, Canada, Chile, and Mexico Chapter 3: European Union, United Kingdom, and Switzerland Chapter 4: Australia, New Zealand, Malaysia, and Singapore Chapter 5: Middle East North Africa Section II: Quality/Chemistry, Manufacturing, and Control Changes Chapter 6: Argentina, Brazil, Canada, Chile, Mexico, and United States Chapter 7: European Union, United Kingdom, and Switzerland Chapter 8: Australia, New Zealand, Malaysia, and Singapore Chapter 9: Japan Section III: Safety and Product Information-Related Changes Chapter 10: Argentina, Brazil, Canada, Chile, Mexico, and United States Chapter 11: European Union, United Kingdom, and Switzerland Chapter 12: China Chapter 13: Middle East North Africa Chapter 14: Africa Section IV: Postauthorization Commitments and Studies Chapter 15: Argentina, Brazil, Canada, Chile, Mexico, and United States Chapter 16: European Union, United Kingdom, and Switzerland Chapter 17: China Chapter 18: Middle East North Africa Chapter 19: Africa Section V: Postmarketing Surveillance and Risk Management Chapter 20: Argentina, Brazil, Canada, Chile, Mexico, and United States Chapter 21: European Union, United Kingdom, and Switzerland Chapter 22: Africa
Contributing Authors
In each of the 22 chapters, expert authors take a comprehensive global look at the differences between the Americas, Europe, Asia, Middle East and North Africa (MENA), and sub-Saharan Africa. Postapproval Changes for Drugs is organized into five distinct sections according to the type of change being implemented. Each section covers various countries, including Africa, Argentina, Australia, Brazil, Canada, Chile, Malaysia, Mexico, New Zealand, Singapore, Switzerland, UK, and the US—the breadth of countries and regions never before covered in one single [RAPS] resource.
Postapproval Changes for Drugs includes the regulatory requirements, application of the requirements, and case studies with real-life scenarios and industry best practice. This new resource also includes a comprehensive glossary of terms, acronyms, and abbreviations, in addition to an in-depth index to help navigate through this complex regulatory landscape. Postapproval Changes for Drugs describes the regulations, tools, and pathways regulatory professionals need to remain compliant for changes after the initial approval. This valuable, must have resource will benefit all who participate in the commercialization of drugs and biological products.