Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices
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| 020 | |a 9783527333264 |c hardback : EUR 99.00 (DE) (freier Pr.), ca. EUR 82.20 (AT) (freier Pr.), ca. sfr 109.00 (freier Pr.) |9 978-3-527-33326-4 | ||
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| 049 | |a DE-29 |a DE-19 | ||
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| 100 | 1 | |a Tobin, John J. |e Verfasser |0 (DE-588)135917131 |4 aut | |
| 245 | 1 | 0 | |a Medical product regulatory affairs |b pharmaceuticals, diagnostics, medical devices |c John J. Tobin ; Gary Walsh |
| 250 | |a Second edition | ||
| 264 | 1 | |a [Weinheim] |b Wiley-VCH |c [2024] | |
| 264 | 4 | |c © 2024 | |
| 300 | |a xiii, 316 Seiten |b Illustrationen, Diagramme | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 610 | 2 | 7 | |a Europäische Union |0 (DE-588)5098525-5 |2 gnd |9 rswk-swf |
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| 651 | 7 | |a USA |0 (DE-588)4078704-7 |2 gnd |9 rswk-swf | |
| 689 | 0 | 0 | |a Europäische Union |0 (DE-588)5098525-5 |D b |
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| 689 | 0 | 2 | |a USA |0 (DE-588)4078704-7 |D g |
| 689 | 0 | |5 DE-604 | |
| 700 | 1 | |a Walsh, Gary |e Verfasser |0 (DE-588)13591714X |4 aut | |
| 776 | 0 | 8 | |i Erscheint auch als |n Online-Ausgabe, ePDF |z 978-3-527-68897-5 |
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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 |
| any_adam_object | 1 |
| any_adam_object_boolean | 1 |
| author | Tobin, John J. Walsh, Gary |
| author_GND | (DE-588)135917131 (DE-588)13591714X |
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| author_role | aut aut |
| author_sort | Tobin, John J. |
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| building | Verbundindex |
| bvnumber | BV049350455 |
| ctrlnum | (OCoLC)1407253453 (DE-599)DNB1050181093 |
| discipline | Biologie |
| discipline_str_mv | Biologie |
| edition | Second edition |
| format | Book |
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| id | DE-604.BV049350455 |
| illustrated | Illustrated |
| index_date | 2024-07-03T22:49:33Z |
| indexdate | 2024-08-04T00:29:09Z |
| institution | BVB |
| isbn | 9783527333264 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-034610852 |
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| physical | xiii, 316 Seiten Illustrationen, Diagramme |
| publishDate | 2024 |
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| publisher | Wiley-VCH |
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| spelling | Tobin, John J. Verfasser (DE-588)135917131 aut Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices John J. Tobin ; Gary Walsh Second edition [Weinheim] Wiley-VCH [2024] © 2024 xiii, 316 Seiten Illustrationen, Diagramme txt rdacontent n rdamedia nc rdacarrier Europäische Union (DE-588)5098525-5 gnd rswk-swf Arzneimittelrecht (DE-588)4003139-1 gnd rswk-swf USA (DE-588)4078704-7 gnd rswk-swf Europäische Union (DE-588)5098525-5 b Arzneimittelrecht (DE-588)4003139-1 s USA (DE-588)4078704-7 g DE-604 Walsh, Gary Verfasser (DE-588)13591714X aut Erscheint auch als Online-Ausgabe, ePDF 978-3-527-68897-5 Erscheint auch als Online-Ausgabe, ePub 978-3-527-68898-2 X:MVB text/html http://deposit.dnb.de/cgi-bin/dokserv?id=4642568&prov=M&dok_var=1&dok_ext=htm Inhaltstext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034610852&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Tobin, John J. Walsh, Gary Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices Europäische Union (DE-588)5098525-5 gnd Arzneimittelrecht (DE-588)4003139-1 gnd |
| subject_GND | (DE-588)5098525-5 (DE-588)4003139-1 (DE-588)4078704-7 |
| title | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_auth | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_exact_search | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_exact_search_txtP | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_full | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices John J. Tobin ; Gary Walsh |
| title_fullStr | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices John J. Tobin ; Gary Walsh |
| title_full_unstemmed | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices John J. Tobin ; Gary Walsh |
| title_short | Medical product regulatory affairs |
| title_sort | medical product regulatory affairs pharmaceuticals diagnostics medical devices |
| title_sub | pharmaceuticals, diagnostics, medical devices |
| topic | Europäische Union (DE-588)5098525-5 gnd Arzneimittelrecht (DE-588)4003139-1 gnd |
| topic_facet | Europäische Union Arzneimittelrecht USA |
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