Fundamentals of International Regulatory Affairs, First Edition

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This essential text provides a comprehensive understanding of established international regulations across product lines. It covers important international regulatory requirements, including ICH, GHTF, WHO and ISO guidance documents, and compares submission requirements around the world.

Take advantage of the convenient comparative matrix to quickly reference major guidelines and regulations.

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Who should use this publication?

Fundamentals is designed to be a reference resource for regulatory professionals at all levels—from those new to the field or preparing for the Global RAC exam, to senior management looking for a quick fact or information on a less-familiar product line.

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Get the e-book version when you select the bundled option for $60 more. The e-book is compatible with any device that will read an .epub file, including iPads and most tablet readers.

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Fundamentals of International Regulatory Affairs

Chapters
Chapter 1: Introduction to Regulatory Affairs	1
Chapter 2: Premarket Requirements/Dossier Requirements	7
Chapter 3: Authorization Procedures for Medicinal oducts	15
Chapter 4: Quality Systems and Inspectorate Process—Pharmaceuticals	31
Chapter 5: Pharmaceutical Postmarketing and Compliance	43
Chapter 6: High-Risk Products Derived From Biotechnology	55
Chapter 7: Generic Drug Products and Biosimilars	69
Chapter 8: Principles of Orphan Drugs	81
Chapter 9: Food Supplements and Cosmetic Products	87
Chapter 10: Veterinary Medicinal Products	97
Chapter 11: Over-the-Counter Products (OTCs	111
Chapter 12: Medical Device Premarket Requirements	117
Chapter 13: Technical and Regulatory Requirements for Medical Devices	137
Chapter 14: Postmarket Requirements for Medical Devices	147
Chapter 15: In Vitro Diagnostic Medical Devices	153
Chapter 16: Advertising and Promotion	161
Chapter 17: Compliance and Enforcement	167

Figures and Tables
Figure 2-1. Diagrammatic Representation of the Organization of the ICH CTD	9
Figure 3-1. Overview of a Typical Quality Risk Management Process	20
Figure 3-2. Procedure for Drug Registration	25
Figure 3-3. Mutual Recognition Procedure in the EU	25
Figure 3-4. Decentralised Procedure (DP) in the EU	26
Figure 3-5. Centralised Procedure (CP) in the EU	27
Table 4-1. Application of ICH Q7 to API Manufacturing	36
Table 5-1. Application of Process Performance and Product Quality Monitoring System Throughout the Product Lifecycle	45
Table 5-2. Application of a CAPA System Throughout the Product Lifecycle	46
Table 5-3. Application of Change Management System Throughout the Product Lifecycle	47
Table 5-4. Application of a Management Review of Process Performance and Product Quality Throughout the Product Lifecycle	48
Table 5-5. Differences Between Old and New EU Variations Regulations	50
Table 5-6. FDA Postapproval Change Reporting	51
Table 5-7. Summary of Australian Guidelines on Drug Sponsor Reporting of Adverse Drug Reactions	52
Table 7-1. Biosimilars Authorized for Marketing by the European Commission	75
Table 7-2. Some FOBs Approved by FDA as §505(b)(2) Generic Drugs	76
Table 8-1. Epidemiologic Thresholds of Orphan Diseases in Various Countries/Regions	84
Table 8-2. Overview of Different Orphan Drug Legislation	85
Table 9-1. RDAs of Vitamins and Minerals	89
Table 9-2. Dietary Reference Intakes (DRIs): Recommended Intakes for Individual, Vitamins	90
Table 9-3. Dietary Reference Intakes (DRIs): Recommended Intakes for Individuals, Elements	91
Table 9-4. Dietary Reference Intakes (DRIs): Tolerable Upper Intake Levels (UL) Vitamins	92
Table 9-5. Dietary Reference Intakes (DRIs): Tolerable Upper Intake Levels (UL), Elements	93
Figure 10-1. VICH Steering Committee	101
Figure 10-2. Information Flow in the Pharmacovigilance System	106
Table 12-1. Class A Device	121
Table 12-2. Class B Device	122
Table 12-3. Class C Device	122
Table 12-4. Class D Device	123
Table 12-5. Noninvasive Devices	124
Table 12-6. Invasive Devices	126
Table 12-7. Active Devices	128
Table 12-8. Additional Rules	130
Figure 12-1. Decision Tree Noninvasive Devices	131
Figure 12-2. Decision Tree Invasive Devices	132
Figure 12-3. Decision Tree Invasive Devices	133
Figure 12-4. Decision Tree Active Devices	134
Figure 12-5. Decision Tree Active Devices	135
Figure 12-6. Decision Tree Additional Rules	136
Figure 13-1. Premarket Use of the STED	139
Figure 13-2. Postmarket Use of the STED	141
Figure 13-3. Postmarket Use of the STED	143
Figure 13-4. Key Activities for Supplier Control	144
Figure 14-1. CAs Reporting Flowchart	149
Figure 15-1. General GHTF Classification System for IVD Medical Devices	154
Figure 15-2. Regulatory Requirements Related to the Device Risk Class	154
Table 15-1. Classification Rules for IVDs	155
Table 15-2. Classification Rules for IVD	156
Table 15-3. Class A Device	157
Table 15-4. Class B Device	158
Table 15-5. Class C Device	158
Table 15-6. Class D Device	159
Figure 17-1. Flow Chart—Overview of Typical Audit Process	173

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