Verfügbarkeit: Medical product regulatory affairs

Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices

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Bibliographische Detailangaben
Hauptverfasser:	Tobin, John J. (VerfasserIn), Walsh, Gary (VerfasserIn)
Format:	Buch
Sprache:	English
Veröffentlicht:	[Weinheim] Wiley-VCH [2024]
Ausgabe:	Second edition
Schlagworte:	Europäische Union Arzneimittelrecht USA
Online-Zugang:	Inhaltstext Inhaltsverzeichnis
Beschreibung:	xiii, 316 Seiten Illustrationen, Diagramme
ISBN:	9783527333264

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MARC


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Datensatz im Suchindex

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adam_text	CONTENTS 1 THE AIMS AND STRUCTURE OF REGULATIONS 1 1.1 INTRODUCTION 1 1.2 PURPOSE AND PRINCIPLES OF REGULATION 1 1.3 THE LEGAL FRAMEWORK FOR REGULATION 3 1.3.1 NATIONAL LEGISLATIVE PROCESS 3 1.3.2 EU LEGISLATIVE PROCESS 4 1.3.3 WORKING WITH LEGAL TEXTS 6 1.3.4 GUIDANCE DOCUMENTS 7 1.3.5 PHARMACOPOEIA 7 1.4 BASIC LEGISLATION 7 1.4.1 EU LEGISLATION 7 1.4.2 US LEGISLATION 12 1.5 SCOPE OF THE LEGISLATION 15 1.6 CHAPTER REVIEW 20 1.7 FURTHER READING 21 2 REGULATORY STRATEGY 23 2.1 CHAPTER INTRODUCTION 23 2.2 BASIC REGULATORY STRATEGY 23 2.2.1 PRODUCT DEVELOPMENT 23 2.2.2 PRODUCT MANUFACTURE 23 2.2.3 MARKET VIGILANCE 24 2.3 QUALITY ASSURANCE SYSTEMS 25 2.3.1 PERSONNEL 25 2.3.2 DOCUMENTATION 25 2.3.3 FACILITIES AND EQUIPMENT 26 2.3.4 CORRECTIVE AND PREVENTATIVE ACTION 27 2.4 VALIDATION 27 2.5 REGULATORY BODIES 29 VI CONTENTS 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6 2.5.7 2.6 2.7 EUROPEAN COMMISSION 29 THE EMA 30 NATIONAL COMPETENT AUTHORITIES 32 NOTIFIED BODIES 34 THE FDA 35 US DEPARTMENT OF AGRICULTURE (USDA) 39 PHARMACOPOEIA AUTHORITIES 39 INTERNATIONAL HARMONISATION BODIES 40 INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 41 2.7.1 2.7.2 2.8 2.9 2.10 2.11 VICH 43 THE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) 43 PHARMACEUTICAL INSPECTION COOPERATION SCHEME (PICS) 44 THE WORLD HEALTH ORGANISATION (WHO) 45 CHAPTER REVIEW 45 FURTHER READING 46 3 DRUG DISCOVERY, CLASSIFICATION AND EARLY STAGE DEVELOPMENT 47 3.1 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.3 3.3.1 3.3.2 3.4 3.4.1 3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.6 3.7 CHAPTER INTRODUCTION 47 DRUG CATEGORISATION 47 PRESCRIPTION STATUS 47 PHYSICAL PROPERTIES 48 MODE OF ACTION 48 THERAPEUTIC USE 49 DRUG DISCOVERY 51 TARGET DISCOVERY AND VALIDATION 52 LEAD DISCOVERY, VALIDATION AND OPTIMISATION 57 DRUG DEVELOPMENT 58 MANUFACTURE AND CONTROL 59 DRUG DELIVERY 59 LOCATION 60 DRUG CHARACTERISTICS 60 SPEED AND DURATION OF THERAPEUTIC EFFECT 62 STABILITY 63 CHAPTER REVIEW 63 FURTHER READING 63 4 4.1 4.2 4.3 NON-CLINICAL STUDIES 65 CHAPTER INTRODUCTION 65 NON-CLINICAL STUDY OBJECTIVES AND TIMING 65 PHARMACOLOGICAL STUDIES 69 CONTENTS VI 4.3.1 PHARMACODYNAMIC STUDIES 70 4.3.2 PHARMACOKINETIC/TOXICOKINETIC STUDIES 72 4.4 BIOAVAILABILITY AND BIOEQUIVALENCE 73 4.5 TOXICOLOGY STUDIES 74 4.5.1 TOXICITY STUDIES 74 4.5.2 GENOTOXICITY STUDIES 75 4.5.3 CARCINOGENICITY STUDIES 76 4.5.4 REPRODUCTIVE TOXICOLOGY STUDIES 76 4.6 CHEMISTRY, MANUFACTURING AND CONTROL DEVELOPMENT (CMC) 77 4.7 QUALITY BY DESIGN (QBD) 77 4.8 QUALITY OF BIOTECH PRODUCTS 78 4.8.1 STABILITY STUDIES 78 4.9 GOOD LABORATORY PRACTICE (GLP) 78 4.10 CHAPTER REVIEW 80 4.11 FURTHER READING 83 5 CLINICAL TRIALS 85 5.1 CHAPTER INTRODUCTION 85 5.2 CLINICAL TRIALS 85 5.2.1 PHASE I TRIALS 86 5.2.2 PHASE II TRIALS 86 5.2.3 PHASE III TRIALS 87 5.3 CLINICAL TRIAL DESIGN 88 5.4 GOOD CLINICAL PRACTICE 90 5.5 CLINICAL TRIALS IN THE EU 90 5.5.1 SPONSOR 93 5.5.2 INVESTIGATOR ' S BROCHURE (IB) 93 5.5.3 INVESTIGATOR 94 5.5.4 TRIAL PROTOCOL 94 5.5.5 INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD) 94 .5.5.6 INFORMED CONSENT 94 5.5.7 MANUFACTURE OF INVESTIGATIONAL MEDICINAL PRODUCT 95 5.5.8 CLINICAL TRIAL AUTHORISATION 95 5.5.9 INDEPENDENT ETHICS COMMITTEE OPINION 96 5.5.10 AMENDMENTS TO CLINICAL TRIALS 97 5.5.11 CASE REPORT FORMS (CRFS) 97 5.5.12 ADVERSE EVENT REPORTING 97 5.5.13 ANNUAL SAFETY REPORT 98 5.5.14 MONITORING OF TRIALS 98 5.5.15 END OF TRIAL 98 5.5.16 TRIAL MASTER FILE 98 5.6 CLINICAL TRIALS IN THE US 100 VIII CONTENTS 5.6.1 5.6.2 INVESTIGATIONAL NEW DRUG APPLICATION (IND) 100 INSTITUTIONAL REVIEW BOARD (IRB) 103 5.6.3 COMMUNICATION WITH THE FDA 104 5.6.4 LABELLING OF INVESTIGATIONAL DRUGS 105 5.6.5 REGISTRY OF CLINICAL TRIAL INFORMATION 105 5.7 CHAPTER REVIEW 105 5.8 FURTHER READING 106 6 MARKETING AUTHORISATION 109 6.1 6.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 CHAPTER INTRODUCTION 109 THE APPLICATION DOSSIER 109 CTD 110 MODULE STRUCTURE 112 MODULE 3 - QUALITY 113 DRUG MASTER FILES 116 MODULE 4 - NON-CLINICAL STUDY REPORTS 116 MODULE 5 - CLINICAL STUDY REPORTS 116 MODULE 2 - SUMMARIES 118 6.3.7 MODULE I - REGION SPECIFIC 120 6.3.8 6.3.9 6.4 MODULE 1 - EU 121 MODULE 1 - US 123 SUBMISSION AND REVIEW PROCESS IN THE EU 127 6.4.1 UNION AUTHORISATION 128 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 SCIENTIFIC EVALUATION PROCESS 129 DECISION MAKING PROCESS 130 NATIONAL AUTHORISATIONS 132 DECENTRALISED PROCEDURE 132 MUTUAL RECOGNITION PROCEDURE 134 6.4.7 6.5 6.6 6.7 PLASMA MASTER FILES AND VACCINE ANTIGEN MASTER FILES 134 SUBMISSION AND REVIEW PROCESS IN THE US 134 CHAPTER REVIEW 138 FURTHER READING 138 7 AUTHORISATION OF VETERINARY MEDICINES 139 7.1 7.2 CHAPTER INTRODUCTION 139 OVERVIEW OF DEVELOPMENT PROCESS FOR VETERINARY MEDICINES 139 7.2.1 7.2.2 7.2.3 7.3 PRE-CLINICAL STUDIES 140 CLINICAL TRIALS 141 GOOD CLINICAL PRACTICES 141 AUTHORISATION OF CLINICAL TRIALS IN THE EU 145 7.4 AUTHORISATION OF CLINICAL TRIALS IN THE US 146 CONTENTS IX 7.5 7.6 7.6.1 7.6.2 7.6.3 7.6.4 7.7 7.7.1 7.7.2 7.8 7.9 MAXIMUM RESIDUE LIMITS (MRLS) 147 AUTHORISATION OF VETERINARY MEDICINES IN THE EU 149 APPLICATIONS TO ESTABLISH MRLS 149 REVIEW OF APPLICATIONS AND ESTABLISHMENT OF MRLS 152 MARKETING AUTHORISATIONS 156 PRESENTATION OF THE DOSSIER 156 APPROVAL OF VETERINARY MEDICINES IN THE US 158 NEW ANIMAL DRUG APPLICATION (NADA) 158 APPROVAL OF VETERINARY BIOLOGICAL PRODUCTS 163 CHAPTER REVIEW 164 FURTHER READING 164 8 8.1 8.2 8.2.1 8.2.2 8.3 8.3.1 8.3.2 8.3.3 8.3.4 8.4 VARIATIONS TO THE DRUG AUTHORISATION PROCESS 165 CHAPTER INTRODUCTION 165 PROVISIONS IN SUPPORT OF SPECIAL DRUG APPLICATIONS 165 ORPHAN DRUGS 165 PAEDIATRIC APPLICATIONS 167 ACCELERATED ACCESS TO NEW DRUG THERAPIES 170 EMA ACCELERATED REVIEW AND CONDITIONAL MARKETING ROUTES 170 EU COMPASSIONATE USE 171 EXPEDITED PATHWAYS IN THE US 171 EXPANDED ACCESS AND EMERGENCY USE AUTHORIZATION (EUA) 174 APPROVAL OF NEW DRUGS WHEN HUMAN EFFICACY STUDIES ARE NOT ETHICAL OR FEASIBLE 175 8.5 8.5.1 8.5.2 8.5.3 8.6 ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 176 CONDITIONAL APPROVAL 176 INDEXING 176 DESIGNATION 176 SPECIAL PROVISIONS TO FACILITATE ACCESS TO DRUGS FOR ANIMAL TREATMENT IN THEEU 177 8.7 8.8 8.8.1 8.8.2 8.8.3 8.9 8.9.1 8.9.2 8.9.3 8.9.4 8.10 CHANGES TO AN AUTHORISED DRUG 177 EU SYSTEM FOR PROCESSING CHANGES 177 EXTENSION APPLICATIONS 178 MAJOR VARIATION (TYPE II) 178 MINOR VARIATION (TYPE IA OR IB) 179 PROCESSING CHANGES IN THE US 179 MANUFACTURING CHANGE SUPPLEMENTS 180 MAJOR CHANGES 180 MODERATE CHANGES 180 MINOR CHANGES 181 AUTHORISATION OF GENERIC DRUGS 181 X CONTENTS 8.10.1 8.10.2 8.11 8.11.1 8.11.2 8.12 8.13 8.13.1 8.13.2 8.13.3 8.13.4 8.13.5 8.14 8.15 EU REGULATIONS 181 US REGULATIONS 182 BIOSIMILARS 183 EU REGULATIONS 184 US REGULATIONS 185 REFERENCE DRUG EXCLUSIVITY 189 OTHER AUTHORISATION PROCEDURES 191 WELL-ESTABLISHED MEDICAL USE PRODUCTS 191 COMBINATION PRODUCTS 191 HOMEOPATHIC MEDICINES 192 TRADITIONAL HERBAL MEDICINES 192 US REGULATION OF OTC DRUGS 193 CHAPTER REVIEW 193 FURTHER READING 194 9 9.1 9.2 9.2.1 9.2.2 9.3 9.3.1 9.3.1.1 9.3.1.2 9.3.1.3 9.3.2 9.4 9.4.1 9.4.2 9.4.3 9.4.4 9.4.5 9.4.6 9.4.7 9.4.8 9.5 9.6 MEDICAL DEVICES 195 CHAPTER INTRODUCTION 195 REGULATORY STRATEGY FOR MEDICAL DEVICES IN THE EU 195 USE OF STANDARDS TO ESTABLISH CONFORMITY 200 CLASSIFICATION OF DEVICES 201 REGULATORY STRATEGY FOR MEDICAL DEVICES IN THE US 210 CLASSIFICATION OF DEVICES 210 CLASSI 211 CLASS II 211 CLASS III 211 CLASSIFICATION OF NEW DEVICES 212 DEVELOPMENT OF DEVICES 212 DESIGN CONTROLS 213 DESIGN AND DEVELOPMENT PLANNING 214 DESIGN INPUT 214 DESIGN OUTPUT 216 DESIGN VERIFICATION AND DESIGN VALIDATION 216 DESIGN REVIEW 217 RISK ANALYSIS 218 DESIGN CHANGES 218 CHAPTER REVIEW 218 FURTHER READING 219 10 10.1 10.2 10.2.1 AUTHORISATION OF MEDICAL DEVICES 221 CHAPTER INTRODUCTION 221 EVALUATION OF MEDICAL DEVICES IN EUROPE 221 CLINICAL EVALUATION 221 CONTENTS XI 10.2.2 10.2.3 10.2.4 10.3 10.3.1 10.3.2 10.3.3 10.3.4 10.4 10.4.1 10.4.2 10.4.2.1 CLINICAL INVESTIGATIONS 222 PERFORMANCE EVALUATION OF IVDS 225 PERFORMANCE STUDIES OF IVDS 225 EVALUATION OF MEDICAL DEVICES IN THE US 226 EXEMPTED INVESTIGATIONS 227 ABBREVIATED REQUIREMENT INVESTIGATIONS 227 IDE INVESTIGATIONS 227 LABELLING OF DEVICES FOR INVESTIGATIONAL USE 229 PLACING OF DEVICES ON THE MARKET IN THE EU 230 DESIGNATION OF NOTIFIED BODIES 230 CONFORMITY ASSESSMENT PROCEDURES 232 CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ASSESSMENT OF TECHNICAL DOCUMENTATION 233 10.4.2.2 10.4.2.3 10.4.2.4 10.4.2.5 10.4.3 10.4.4 10.4.5 10.5 10.5.1 10.5.2 10.5.3 10.5.4 10.5.5 10.5.6 10.5.7 10.5.8 10.5.9 10.5.10 10.6 10.7 EU TYPE-EXAMINATION 235 PRODUCTION QUALITY ASSURANCE 235 EU VERIFICATION 235 EU (SELF) DECLARATION OF CONFORMITY 236 TECHNICAL DOCUMENTATION 236 LABELLING REQUIREMENTS 236 REGISTRATION OF ECONOMIC OPERATORS AND DEVICES 238 PLACING OF DEVICES ON THE MARKET IN THE US 238 510(K) PRE-MARKET NOTIFICATION 239 TRADITIONAL 510(K) 239 ABBREVIATED 510(K) 239 SPECIAL 510(K) 239 DE NOVO 510(K) 240 NOTIFICATION AND REVIEW PROCEDURES 240 PRE-MARKET APPROVAL (PMA) 240 CHANGES TO A PMA-APPROVED DEVICE 241 HUMANITARIAN USE DEVICES (HUDS) 243 LABELLING OF DEVICES 243 CHAPTER REVIEW 243 FURTHER READING 244 11 11.1 11.2 11.3 11.3.1 11.3.2 11.3.3 11.3.4 GOOD MANUFACTURING PRACTICE (GMP) 245 CHAPTER INTRODUCTION 245 DRUG GMP REGULATIONS AND GUIDANCE 245 ESSENTIAL GMP REQUIREMENTS 248 QUALITY ASSURANCE SYSTEM 248 PERSONNEL 248 PREMISES AND EQUIPMENT 249 DOCUMENTATION 257 XII CONTENTS 11.3.5 11.3.6 11.3.7 11.3.8 11.3.9 11.4 11.4.1 11.4.2 11.4.3 11.4.4 11.4.5 11.4.6 11.4.7 11.5 11.6 11.7 PRODUCTION 257 QUALITY CONTROL 258 WORK CONTRACTED OUT 259 COMPLAINTS, PRODUCT RECALL AND EMERGENCY UN-BLINDING 259 SELF-INSPECTION 259 VALIDATION 260 FACILITIES AND EQUIPMENT VALIDATION 261 PROCESS VALIDATION 262 COMPUTER SYSTEMS VALIDATION 262 METHODS VALIDATION 265 CLEANING VALIDATION 266 VALIDATION OF STERILISATION PROCEDURES 267 WATER PURIFICATION SYSTEM VALIDATION 268 GMP REQUIREMENTS FOR DEVICES 268 CHAPTER REVIEW 273 FURTHER READING 273 12 12.1 12.2 12.3 12.3.1 12.3.2 OVERSIGHT AND VIGILANCE 275 CHAPTER INTRODUCTION 275 REGISTRATION OF MANUFACTURERS AND OTHER ENTITIES 275 MANUFACTURING AUTHORISATION OF MEDICINAL PRODUCTS IN THE EU 275 WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS 276 REGISTRATION OF ECONOMIC OPERATORS FOR MEDICAL DEVICES ON THE EU MARKET 278 12.4 12.5 12.6 12.6.1 12.6.2 12.7 12.7.1 12.7.2 REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES IN THE US 278 ADDITIONAL LICENSING REQUIREMENTS 279 INSPECTIONS 279 INSPECTION TECHNIQUES 280 AUDIT FINDINGS AND CONSEQUENCES 286 MARKET VIGILANCE AND OVERSIGHT OF DRUGS 289 PHARMACOVIGILANCE IN THE EU 289 PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC) AND THE EUDRAVIGILANCE SYSTEM 290 12.7.3 12.7.4 12.7.5 12.7.6 12.7.7 12.8 PHARMACOVIGILANCE AND MARKETING AUTHORISATION HOLDERS 293 PHARMACOVIGILANCE INSPECTIONS AND AUDITS 294 RENEWAL OF MARKETING AUTHORISATIONS 295 PHARMACOVIGILANCE AND REPORTING IN THE US 295 PERIODIC REPORTS 296 ADVERTISING AND PROMOTION 297 CONTENTS XIII 12.9 12.9.1 12.9.2 12.9.3 12.9.4 12.9.5 12.10 12.11 MARKET VIGILANCE AND OVERSIGHT OF DEVICES 298 MARKET VIGILANCE IN THE EU 298 MEDICAL DEVICE VIGILANCE IN THE US 299 MEDICAL DEVICE REPORTING 299 REPORTS OF CORRECTIONS AND REMOVALS 300 POST-MARKET SURVEILLANCE 302 CHAPTER REVIEW 303 FURTHER READING 303 INDEX 305
adam_txt	CONTENTS 1 THE AIMS AND STRUCTURE OF REGULATIONS 1 1.1 INTRODUCTION 1 1.2 PURPOSE AND PRINCIPLES OF REGULATION 1 1.3 THE LEGAL FRAMEWORK FOR REGULATION 3 1.3.1 NATIONAL LEGISLATIVE PROCESS 3 1.3.2 EU LEGISLATIVE PROCESS 4 1.3.3 WORKING WITH LEGAL TEXTS 6 1.3.4 GUIDANCE DOCUMENTS 7 1.3.5 PHARMACOPOEIA 7 1.4 BASIC LEGISLATION 7 1.4.1 EU LEGISLATION 7 1.4.2 US LEGISLATION 12 1.5 SCOPE OF THE LEGISLATION 15 1.6 CHAPTER REVIEW 20 1.7 FURTHER READING 21 2 REGULATORY STRATEGY 23 2.1 CHAPTER INTRODUCTION 23 2.2 BASIC REGULATORY STRATEGY 23 2.2.1 PRODUCT DEVELOPMENT 23 2.2.2 PRODUCT MANUFACTURE 23 2.2.3 MARKET VIGILANCE 24 2.3 QUALITY ASSURANCE SYSTEMS 25 2.3.1 PERSONNEL 25 2.3.2 DOCUMENTATION 25 2.3.3 FACILITIES AND EQUIPMENT 26 2.3.4 CORRECTIVE AND PREVENTATIVE ACTION 27 2.4 VALIDATION 27 2.5 REGULATORY BODIES 29 VI CONTENTS 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6 2.5.7 2.6 2.7 EUROPEAN COMMISSION 29 THE EMA 30 NATIONAL COMPETENT AUTHORITIES 32 NOTIFIED BODIES 34 THE FDA 35 US DEPARTMENT OF AGRICULTURE (USDA) 39 PHARMACOPOEIA AUTHORITIES 39 INTERNATIONAL HARMONISATION BODIES 40 INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 41 2.7.1 2.7.2 2.8 2.9 2.10 2.11 VICH 43 THE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) 43 PHARMACEUTICAL INSPECTION COOPERATION SCHEME (PICS) 44 THE WORLD HEALTH ORGANISATION (WHO) 45 CHAPTER REVIEW 45 FURTHER READING 46 3 DRUG DISCOVERY, CLASSIFICATION AND EARLY STAGE DEVELOPMENT 47 3.1 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.3 3.3.1 3.3.2 3.4 3.4.1 3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.6 3.7 CHAPTER INTRODUCTION 47 DRUG CATEGORISATION 47 PRESCRIPTION STATUS 47 PHYSICAL PROPERTIES 48 MODE OF ACTION 48 THERAPEUTIC USE 49 DRUG DISCOVERY 51 TARGET DISCOVERY AND VALIDATION 52 LEAD DISCOVERY, VALIDATION AND OPTIMISATION 57 DRUG DEVELOPMENT 58 MANUFACTURE AND CONTROL 59 DRUG DELIVERY 59 LOCATION 60 DRUG CHARACTERISTICS 60 SPEED AND DURATION OF THERAPEUTIC EFFECT 62 STABILITY 63 CHAPTER REVIEW 63 FURTHER READING 63 4 4.1 4.2 4.3 NON-CLINICAL STUDIES 65 CHAPTER INTRODUCTION 65 NON-CLINICAL STUDY OBJECTIVES AND TIMING 65 PHARMACOLOGICAL STUDIES 69 CONTENTS VI 4.3.1 PHARMACODYNAMIC STUDIES 70 4.3.2 PHARMACOKINETIC/TOXICOKINETIC STUDIES 72 4.4 BIOAVAILABILITY AND BIOEQUIVALENCE 73 4.5 TOXICOLOGY STUDIES 74 4.5.1 TOXICITY STUDIES 74 4.5.2 GENOTOXICITY STUDIES 75 4.5.3 CARCINOGENICITY STUDIES 76 4.5.4 REPRODUCTIVE TOXICOLOGY STUDIES 76 4.6 CHEMISTRY, MANUFACTURING AND CONTROL DEVELOPMENT (CMC) 77 4.7 QUALITY BY DESIGN (QBD) 77 4.8 QUALITY OF BIOTECH PRODUCTS 78 4.8.1 STABILITY STUDIES 78 4.9 GOOD LABORATORY PRACTICE (GLP) 78 4.10 CHAPTER REVIEW 80 4.11 FURTHER READING 83 5 CLINICAL TRIALS 85 5.1 CHAPTER INTRODUCTION 85 5.2 CLINICAL TRIALS 85 5.2.1 PHASE I TRIALS 86 5.2.2 PHASE II TRIALS 86 5.2.3 PHASE III TRIALS 87 5.3 CLINICAL TRIAL DESIGN 88 5.4 GOOD CLINICAL PRACTICE 90 5.5 CLINICAL TRIALS IN THE EU 90 5.5.1 SPONSOR 93 5.5.2 INVESTIGATOR ' S BROCHURE (IB) 93 5.5.3 INVESTIGATOR 94 5.5.4 TRIAL PROTOCOL 94 5.5.5 INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD) 94 .5.5.6 INFORMED CONSENT 94 5.5.7 MANUFACTURE OF INVESTIGATIONAL MEDICINAL PRODUCT 95 5.5.8 CLINICAL TRIAL AUTHORISATION 95 5.5.9 INDEPENDENT ETHICS COMMITTEE OPINION 96 5.5.10 AMENDMENTS TO CLINICAL TRIALS 97 5.5.11 CASE REPORT FORMS (CRFS) 97 5.5.12 ADVERSE EVENT REPORTING 97 5.5.13 ANNUAL SAFETY REPORT 98 5.5.14 MONITORING OF TRIALS 98 5.5.15 END OF TRIAL 98 5.5.16 TRIAL MASTER FILE 98 5.6 CLINICAL TRIALS IN THE US 100 VIII CONTENTS 5.6.1 5.6.2 INVESTIGATIONAL NEW DRUG APPLICATION (IND) 100 INSTITUTIONAL REVIEW BOARD (IRB) 103 5.6.3 COMMUNICATION WITH THE FDA 104 5.6.4 LABELLING OF INVESTIGATIONAL DRUGS 105 5.6.5 REGISTRY OF CLINICAL TRIAL INFORMATION 105 5.7 CHAPTER REVIEW 105 5.8 FURTHER READING 106 6 MARKETING AUTHORISATION 109 6.1 6.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 CHAPTER INTRODUCTION 109 THE APPLICATION DOSSIER 109 CTD 110 MODULE STRUCTURE 112 MODULE 3 - QUALITY 113 DRUG MASTER FILES 116 MODULE 4 - NON-CLINICAL STUDY REPORTS 116 MODULE 5 - CLINICAL STUDY REPORTS 116 MODULE 2 - SUMMARIES 118 6.3.7 MODULE I - REGION SPECIFIC 120 6.3.8 6.3.9 6.4 MODULE 1 - EU 121 MODULE 1 - US 123 SUBMISSION AND REVIEW PROCESS IN THE EU 127 6.4.1 UNION AUTHORISATION 128 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 SCIENTIFIC EVALUATION PROCESS 129 DECISION MAKING PROCESS 130 NATIONAL AUTHORISATIONS 132 DECENTRALISED PROCEDURE 132 MUTUAL RECOGNITION PROCEDURE 134 6.4.7 6.5 6.6 6.7 PLASMA MASTER FILES AND VACCINE ANTIGEN MASTER FILES 134 SUBMISSION AND REVIEW PROCESS IN THE US 134 CHAPTER REVIEW 138 FURTHER READING 138 7 AUTHORISATION OF VETERINARY MEDICINES 139 7.1 7.2 CHAPTER INTRODUCTION 139 OVERVIEW OF DEVELOPMENT PROCESS FOR VETERINARY MEDICINES 139 7.2.1 7.2.2 7.2.3 7.3 PRE-CLINICAL STUDIES 140 CLINICAL TRIALS 141 GOOD CLINICAL PRACTICES 141 AUTHORISATION OF CLINICAL TRIALS IN THE EU 145 7.4 AUTHORISATION OF CLINICAL TRIALS IN THE US 146 CONTENTS IX 7.5 7.6 7.6.1 7.6.2 7.6.3 7.6.4 7.7 7.7.1 7.7.2 7.8 7.9 MAXIMUM RESIDUE LIMITS (MRLS) 147 AUTHORISATION OF VETERINARY MEDICINES IN THE EU 149 APPLICATIONS TO ESTABLISH MRLS 149 REVIEW OF APPLICATIONS AND ESTABLISHMENT OF MRLS 152 MARKETING AUTHORISATIONS 156 PRESENTATION OF THE DOSSIER 156 APPROVAL OF VETERINARY MEDICINES IN THE US 158 NEW ANIMAL DRUG APPLICATION (NADA) 158 APPROVAL OF VETERINARY BIOLOGICAL PRODUCTS 163 CHAPTER REVIEW 164 FURTHER READING 164 8 8.1 8.2 8.2.1 8.2.2 8.3 8.3.1 8.3.2 8.3.3 8.3.4 8.4 VARIATIONS TO THE DRUG AUTHORISATION PROCESS 165 CHAPTER INTRODUCTION 165 PROVISIONS IN SUPPORT OF SPECIAL DRUG APPLICATIONS 165 ORPHAN DRUGS 165 PAEDIATRIC APPLICATIONS 167 ACCELERATED ACCESS TO NEW DRUG THERAPIES 170 EMA ACCELERATED REVIEW AND CONDITIONAL MARKETING ROUTES 170 EU COMPASSIONATE USE 171 EXPEDITED PATHWAYS IN THE US 171 EXPANDED ACCESS AND EMERGENCY USE AUTHORIZATION (EUA) 174 APPROVAL OF NEW DRUGS WHEN HUMAN EFFICACY STUDIES ARE NOT ETHICAL OR FEASIBLE 175 8.5 8.5.1 8.5.2 8.5.3 8.6 ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 176 CONDITIONAL APPROVAL 176 INDEXING 176 DESIGNATION 176 SPECIAL PROVISIONS TO FACILITATE ACCESS TO DRUGS FOR ANIMAL TREATMENT IN THEEU 177 8.7 8.8 8.8.1 8.8.2 8.8.3 8.9 8.9.1 8.9.2 8.9.3 8.9.4 8.10 CHANGES TO AN AUTHORISED DRUG 177 EU SYSTEM FOR PROCESSING CHANGES 177 EXTENSION APPLICATIONS 178 MAJOR VARIATION (TYPE II) 178 MINOR VARIATION (TYPE IA OR IB) 179 PROCESSING CHANGES IN THE US 179 MANUFACTURING CHANGE SUPPLEMENTS 180 MAJOR CHANGES 180 MODERATE CHANGES 180 MINOR CHANGES 181 AUTHORISATION OF GENERIC DRUGS 181 X CONTENTS 8.10.1 8.10.2 8.11 8.11.1 8.11.2 8.12 8.13 8.13.1 8.13.2 8.13.3 8.13.4 8.13.5 8.14 8.15 EU REGULATIONS 181 US REGULATIONS 182 BIOSIMILARS 183 EU REGULATIONS 184 US REGULATIONS 185 REFERENCE DRUG EXCLUSIVITY 189 OTHER AUTHORISATION PROCEDURES 191 WELL-ESTABLISHED MEDICAL USE PRODUCTS 191 COMBINATION PRODUCTS 191 HOMEOPATHIC MEDICINES 192 TRADITIONAL HERBAL MEDICINES 192 US REGULATION OF OTC DRUGS 193 CHAPTER REVIEW 193 FURTHER READING 194 9 9.1 9.2 9.2.1 9.2.2 9.3 9.3.1 9.3.1.1 9.3.1.2 9.3.1.3 9.3.2 9.4 9.4.1 9.4.2 9.4.3 9.4.4 9.4.5 9.4.6 9.4.7 9.4.8 9.5 9.6 MEDICAL DEVICES 195 CHAPTER INTRODUCTION 195 REGULATORY STRATEGY FOR MEDICAL DEVICES IN THE EU 195 USE OF STANDARDS TO ESTABLISH CONFORMITY 200 CLASSIFICATION OF DEVICES 201 REGULATORY STRATEGY FOR MEDICAL DEVICES IN THE US 210 CLASSIFICATION OF DEVICES 210 CLASSI 211 CLASS II 211 CLASS III 211 CLASSIFICATION OF NEW DEVICES 212 DEVELOPMENT OF DEVICES 212 DESIGN CONTROLS 213 DESIGN AND DEVELOPMENT PLANNING 214 DESIGN INPUT 214 DESIGN OUTPUT 216 DESIGN VERIFICATION AND DESIGN VALIDATION 216 DESIGN REVIEW 217 RISK ANALYSIS 218 DESIGN CHANGES 218 CHAPTER REVIEW 218 FURTHER READING 219 10 10.1 10.2 10.2.1 AUTHORISATION OF MEDICAL DEVICES 221 CHAPTER INTRODUCTION 221 EVALUATION OF MEDICAL DEVICES IN EUROPE 221 CLINICAL EVALUATION 221 CONTENTS XI 10.2.2 10.2.3 10.2.4 10.3 10.3.1 10.3.2 10.3.3 10.3.4 10.4 10.4.1 10.4.2 10.4.2.1 CLINICAL INVESTIGATIONS 222 PERFORMANCE EVALUATION OF IVDS 225 PERFORMANCE STUDIES OF IVDS 225 EVALUATION OF MEDICAL DEVICES IN THE US 226 EXEMPTED INVESTIGATIONS 227 ABBREVIATED REQUIREMENT INVESTIGATIONS 227 IDE INVESTIGATIONS 227 LABELLING OF DEVICES FOR INVESTIGATIONAL USE 229 PLACING OF DEVICES ON THE MARKET IN THE EU 230 DESIGNATION OF NOTIFIED BODIES 230 CONFORMITY ASSESSMENT PROCEDURES 232 CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ASSESSMENT OF TECHNICAL DOCUMENTATION 233 10.4.2.2 10.4.2.3 10.4.2.4 10.4.2.5 10.4.3 10.4.4 10.4.5 10.5 10.5.1 10.5.2 10.5.3 10.5.4 10.5.5 10.5.6 10.5.7 10.5.8 10.5.9 10.5.10 10.6 10.7 EU TYPE-EXAMINATION 235 PRODUCTION QUALITY ASSURANCE 235 EU VERIFICATION 235 EU (SELF) DECLARATION OF CONFORMITY 236 TECHNICAL DOCUMENTATION 236 LABELLING REQUIREMENTS 236 REGISTRATION OF ECONOMIC OPERATORS AND DEVICES 238 PLACING OF DEVICES ON THE MARKET IN THE US 238 510(K) PRE-MARKET NOTIFICATION 239 TRADITIONAL 510(K) 239 ABBREVIATED 510(K) 239 SPECIAL 510(K) 239 DE NOVO 510(K) 240 NOTIFICATION AND REVIEW PROCEDURES 240 PRE-MARKET APPROVAL (PMA) 240 CHANGES TO A PMA-APPROVED DEVICE 241 HUMANITARIAN USE DEVICES (HUDS) 243 LABELLING OF DEVICES 243 CHAPTER REVIEW 243 FURTHER READING 244 11 11.1 11.2 11.3 11.3.1 11.3.2 11.3.3 11.3.4 GOOD MANUFACTURING PRACTICE (GMP) 245 CHAPTER INTRODUCTION 245 DRUG GMP REGULATIONS AND GUIDANCE 245 ESSENTIAL GMP REQUIREMENTS 248 QUALITY ASSURANCE SYSTEM 248 PERSONNEL 248 PREMISES AND EQUIPMENT 249 DOCUMENTATION 257 XII CONTENTS 11.3.5 11.3.6 11.3.7 11.3.8 11.3.9 11.4 11.4.1 11.4.2 11.4.3 11.4.4 11.4.5 11.4.6 11.4.7 11.5 11.6 11.7 PRODUCTION 257 QUALITY CONTROL 258 WORK CONTRACTED OUT 259 COMPLAINTS, PRODUCT RECALL AND EMERGENCY UN-BLINDING 259 SELF-INSPECTION 259 VALIDATION 260 FACILITIES AND EQUIPMENT VALIDATION 261 PROCESS VALIDATION 262 COMPUTER SYSTEMS VALIDATION 262 METHODS VALIDATION 265 CLEANING VALIDATION 266 VALIDATION OF STERILISATION PROCEDURES 267 WATER PURIFICATION SYSTEM VALIDATION 268 GMP REQUIREMENTS FOR DEVICES 268 CHAPTER REVIEW 273 FURTHER READING 273 12 12.1 12.2 12.3 12.3.1 12.3.2 OVERSIGHT AND VIGILANCE 275 CHAPTER INTRODUCTION 275 REGISTRATION OF MANUFACTURERS AND OTHER ENTITIES 275 MANUFACTURING AUTHORISATION OF MEDICINAL PRODUCTS IN THE EU 275 WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS 276 REGISTRATION OF ECONOMIC OPERATORS FOR MEDICAL DEVICES ON THE EU MARKET 278 12.4 12.5 12.6 12.6.1 12.6.2 12.7 12.7.1 12.7.2 REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES IN THE US 278 ADDITIONAL LICENSING REQUIREMENTS 279 INSPECTIONS 279 INSPECTION TECHNIQUES 280 AUDIT FINDINGS AND CONSEQUENCES 286 MARKET VIGILANCE AND OVERSIGHT OF DRUGS 289 PHARMACOVIGILANCE IN THE EU 289 PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC) AND THE EUDRAVIGILANCE SYSTEM 290 12.7.3 12.7.4 12.7.5 12.7.6 12.7.7 12.8 PHARMACOVIGILANCE AND MARKETING AUTHORISATION HOLDERS 293 PHARMACOVIGILANCE INSPECTIONS AND AUDITS 294 RENEWAL OF MARKETING AUTHORISATIONS 295 PHARMACOVIGILANCE AND REPORTING IN THE US 295 PERIODIC REPORTS 296 ADVERTISING AND PROMOTION 297 CONTENTS XIII 12.9 12.9.1 12.9.2 12.9.3 12.9.4 12.9.5 12.10 12.11 MARKET VIGILANCE AND OVERSIGHT OF DEVICES 298 MARKET VIGILANCE IN THE EU 298 MEDICAL DEVICE VIGILANCE IN THE US 299 MEDICAL DEVICE REPORTING 299 REPORTS OF CORRECTIONS AND REMOVALS 300 POST-MARKET SURVEILLANCE 302 CHAPTER REVIEW 303 FURTHER READING 303 INDEX 305
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