Fundamentals of EU Regulatory Affairs, Sixth Edition

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This unique publication breaks down complex EU directives, regulations and guidelines into an easy-to-read format. It provides a comprehensive review of human and veterinary medicinal products, biologics, medical devices, cosmetics and food supplements, and applicable international standards and guidances.

New for this edition

Several new chapters have been added that deal with issues of growing importance to EU regulatory professionals, such as reimbursement and the health technology assessments that frequently are the basis for reimbursement decisions. There also is a new chapter on crisis management and one on the special requirements for vaccines. In light of new legislation in effect in 2012, there also is a chapter devoted to pharmacovigilance.

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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 EU RAC exam, to senior management looking for a quick fact or information on a less-familiar product line.

Special offer:

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.

The Fundamentals of Regulatory Affairs series is available for a number of regions, including:

Fundamentals of EU Regulatory Affairs, Sixth Edition

Section I: General Information
Chapter 1 EU Regulatory Affairs—An Historic Perspective	1
Chapter 2 Crisis Management	17
Chapter 3 Reimbursement in the EU	23
Chapter 4 Health Technology Assessment	31
Chapter 5 The Paediatric Regulation	41
Chapter 6 Advertising and Promotion	49
Chapter 7 Enforcement and National Authorities	57

Section II: Medical Devices
Chapter 8 The European Medical Devices Legal System	65
Chapter 9 Classification of Medical Devices	87
Chapter 10 Technical Requirements for Conformity Assessment	93
Chapter 11 Clinical Evaluation of Medical Devices	99
Chapter 12 Conformity Assessment Procedures’ Quality System Requirements	107
Chapter 13 In Vitro Diagnostic Medical Devices	119
Chapter 14 Active Implantable Medical Devices	129
Chapter 15 Medical Device Compliance: Postmarket Requirements	133
Chapter 16 Medical Device National Particularities	143

Section III: Medicinal Products
Chapter 17 Overview of Authorisation Procedures for Medicinal Products	151
Chapter 18 Medicinal Product Clinical Trials	169
Chapter 19 Registration Procedures for Medicinal Products	183
Chapter 20 Quality Systems and Inspectorate Process—Medicinal Products	197
Chapter 21 Generic Medicinal Products	205
Chapter 22 Nonprescription Medicinal Products	213
Chapter 23 Marketing Authorisations for Products Derived From Biotechnology	221
Chapter 24 Pharmaceutical Postmarket Requirements and Compliance With the Marketing Authorisation	231
Chapter 25 Pharmacovigilance	241

Section IV: Other Product Classifications
Chapter 26 Products Manufactures From Human Blood or Plasma	247
Chapter 27 Human Tissue Regulation	255
Chapter 28 Vaccines	269
Chapter 29 Orphan Medicinal Products	283
Chapter 30 Combination Products	293
Chapter 31 Cosmetic Products	301
Chapter 32 Food Supplements, Health Claims and Borderline Issues	311
Chapter 33 Veterinary Medicinal Products	319

Appendices
Comparative Matrix of Regulations, Directives and Guidelines Across Product Lines Glossary of Terms Index	343

Figures
Figure 2-1 Crisis as a Trigger for Change	19
Figure 4-1 Phased Approach to Evaluation of a Health Technology	33
Figure 5-1 Paediatric Investigation Plan (PIP) Approval Process	44
Figure 8-1 EU Legislative Procedure	67
Figure 8-2 Flow Chart for the Conformity Assessment Procedures Provided for in Directive 94/42/EEC on Medical Devices	68
Figure 8-3 Flow Chart for the Conformity Assessment Procedures Provided for in Directive 90/385/EEC on Active Implantable Medical Devices	71
Figure 8-4 Flow Chart for the Conformity Assessment Procedures Provided for in Directive 98/79/EC on In Vitro Diagnostic Medical Devices	72
Figure 8-5 Clinical Evaluation Cycle	79
Figure 11-1 Clinical Evaluation Flow Diagram for all Device Types	101
Figure 11-2 The Clinical Evaluation Process	104
Figure 12-1 CAPS for Active Implantable Medical Devices	109
Figure 12-2 CAP Risk Class I Medical Devices	112
Figure 12-3 CAPs for Risk Class IIa Medical Devices	113
Figure 12-4 CAPs for Risk Class IIb Medical Devices	113
Figure 12-5 CAPs for Rick Class III Medical Devices	114
Figure 12-6 CAP for all In Vitro Medical Devices	115
Figure 12-7 CAPS for Self-testing In Vitro Medical Devices	115
Figure 12-8 CAPS for Annex II List B In Vitro Medical Devices	116
Figure 12-9 CAPS for Annex II List A In Vitro Medical Devices	116
Figure 13-1 Flowchart for the CAPs Provided for in Directive 98/79/EC	123
Figure 18-1 Commencement of a Clinical Trial	172
Figure 18-2 Serious Adverse Event Reporting	175
Figure 28-1 OCABR Decision Flowchart	275
Figure 28-2 Process for Production and Licensing of Seasonal Influenza Vaccines in Europe	278
Figure 29-1 Orphan Designation Criteria	289
Figure 30-1 Consultation Procedure and Timeline	298

Tables
Table 4-1 REA Checklist	37
Table 8-1 European Council Weighted Votes	66
Table 8-2 New Approach Areas	73
Table 8-3 EU Member States and Affiliated Countries Competent Authorities	74
Table 8-4 European Commission Working Groups and Their Activities	76
Table 8-5 European Industrial Trade Associations	78
Table 8-6 MEDDEV Guidance Documents	80
Table 8-7 European Commission Consensus Statements	82
Table 8-8 Interpretive Documents Issues by the European Commission	83
Table 8-9 NBOG Documents	84
Table 10-1 Essential Requirement Checklist: Example (MDD (Directive 93/42/EEC), as amended—Annex I) 95	95
Table 10-2 Hierarchy of Compliance Document for Technical Documentation	96
Table 11-1 Abbreviations, Definitions and Terms Used in This Chapter	102
Table 12-1 Conformity Assessment Documentation	110
Table 12-2 International Production Control	117
Table 12-3 EC Type-examination	117
Table 12-4 Production Quality Assurance	117
Table 12-5 Product Quality Assurance	117
Table 12-6 Product Verification	117
Table 12-7 Full Quality Assurance System	117
Table 12-8 Authorised Representative in Conformity Assessment	118
Table 13-1 Examples of General Laboratory Use Products and IVD Medical Devices	121
Table 14-1 Comparison of AIMDD and MDD Annexes	130
Table 15-1 Eudamed Data Repository	137
Table 15-2 Comparison of Safeguard Clause and Health Monitoring Measures	140
Table 16-1 Relevant Authorities in Germany	149
Table 17-1 Standard Timetable for Evaluation of a Centralised Appliation	156
Table 17-2 Mutual Recognition Procedure Flowchart	160
Table 17-3 Decentralised Procedure Flowchart	163
Table 18-1 Practical Notes for Clinical Trials	171
Table 19-1 Procedures to Obtain MA	187
Table 19-2 Centralised Procedure	188
Table 19-3 Mutual Recognition Procedure	189
Table 19-4 Decentralised Procedure	190
Table 19-5 A Comparison of the Centralised, Decentralised and Mutual Recognition Procedures	193
Table 22-1 Legal Classification Status of Selected Ingredients in the EU	216
Table 26-1 Medicinal Products Derived From Human Plasma and Their Indications	249
Table 27-1 Donor Testing for Infectious Diseases	259
Table 28-1 Vaccine Guidelines	272
Table 28-2 Adjuvants Licensed in the EU	274
Table 28-3 European Guidelines for Influenza Vaccines	276
Table 28-4 Some Organisations Involved in Vaccine Recommendations in the EU	280
Table 29-1 Comparison of the EU and US Orphan Programmes	286
Table 31-1 Annexes to the Cosmetics Directive and Cosmetic Regulation	305
Table 31-2 Ingredient Nomenclature for Labels	308
Table 32-1 Vitamins and Minerals That May Be Declared and Their Recommended Daily Allowances (RDAs)	313
Table 33-1 Legislative Framework for Registration of Veterinary Medicinal Products Within the EEA	321
Table 33-2 Competent Authorities for the Regulation of Veterinary Medicinal Products in the EEA	330
Table 33-3 Food-producing Species	334
Table 33-4 MUMS Guidelines	337

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