Effective drug regulation: a multicountry study
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Geneva
World Health Organization
2002
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | IX, 142, 47 S. graph Darst. |
| ISBN: | 9241562064 |
Internformat
MARC
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| 245 | 1 | 0 | |a Effective drug regulation |b a multicountry study |c by Sauwakon Ratanawijitrasin ; Eshetu Wondemagegnehu |
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| 650 | 7 | |a Drugsgebruik |2 gtt | |
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| 650 | 4 | |a Médicaments - Droit | |
| 650 | 4 | |a Médicaments - Politique gouvernementale | |
| 650 | 7 | |a Regulering |2 gtt | |
| 650 | 4 | |a Recht | |
| 650 | 4 | |a Drugs |x Law and legislation |x International cooperation | |
| 650 | 4 | |a Pharmaceutical policy |x International cooperation | |
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Datensatz im Suchindex
| _version_ | 1804129854241636352 |
|---|---|
| adam_text | Contents
1. DRUG REGULATION: OBJECTIVES AND ISSUES 7
1.1 drugs as an instrument of pubuc health 7
1.2 controlling private behaviour for pubuc purposes 7
1.3 Objectives and organization of this report 9
2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION 11
2.1 project rationale and development 11
2.2 Study objectives 11
2.3 Method of study 12
2.4 Drug regulation from a comparative perspective 14
3. PROFILE OF THE COUNTRIES 17
3.1 General background 17
3.2 Political environment 19
3.3 Pharmaceutical sector environment 21
4. REGULATORY FRAMEWORK 25
4.1 missions and goals of drug regulation 25
4.2 domains of control 26
4.3 other non regulatory pharmaceutical functions 32
4.4 National drug policy 32
4.5 Historical development of drug regulation 32
5. REGULATORY CAPACITY 39
5.1 legal basis, organizational structure and authority 39
5.2 Human resources 45
5.3 Financing drug regulation 48
5.4 Planning, monitoring and evaluating implementation 53
5.6 Political influence and accountability 55
6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE 59
6.1 power and process 59
6.2 Human resources 60
6.3 Paying for licensing 60
6.4 Performance 62
7. INSPECTION AND SURVEILLANCE 65
7.1 power and process: comparing structures and processes 65
7.2 human resources 67
7.3 paying for inspection 70
7.4 Planning, process and performance 70
8. PRODUCT ASSESSMENT AND REGISTRATION 75
8.1 Power and process 75
8.2 Human resources 81
8.3 Paying for registration 82
8.4 Performance 84
8.5 adverse drug reaction monitoring 90
8.6 clinical trials 95
9. CONTROL OF DRUG PROMOTION AND ADVERTISING 99
9.1 power and process: comparing structures and processes 99
9.2 Performance 102
10. DRUG QUALITY CONTROL LABORATORY 105
10.1 Power and process 105
10.2 Human resources 108
10.3 Paying for quauty control 109
10.4 Performance Ill
11. ASSESSING REGULATORY PERFORMANCE 115
11.1 Assessing government functions: an essential part of policy making 115
11.2 Monitoring and evaluation system 115
11.3 Monitors and evaluating the effectiveness of drug regulation 118
11.4 Monitoring and evaluating the efficiency of drug regulation 127
11.5 Monitoring and evaluating the accountability and transparency of drug
regulation 128
11.6 Availability of information for assessment 129
12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG
REGULATION 131
12.1 conclusions related to regulatory structures 131
12.2 Conclusions related to regulatory processes 136
12.3 Recommendations for effective drug regulation 139
|
| any_adam_object | 1 |
| author | Ratanawijitrasin, Sauwakon Wondemagegnehu, Eshetu |
| author_facet | Ratanawijitrasin, Sauwakon Wondemagegnehu, Eshetu |
| author_role | aut aut |
| author_sort | Ratanawijitrasin, Sauwakon |
| author_variant | s r sr e w ew |
| building | Verbundindex |
| bvnumber | BV016542896 |
| callnumber-first | R - Medicine |
| callnumber-label | RA401 |
| callnumber-raw | RA401.A3 |
| callnumber-search | RA401.A3 |
| callnumber-sort | RA 3401 A3 |
| callnumber-subject | RA - Public Medicine |
| classification_rvk | QR 525 |
| ctrlnum | (OCoLC)55846864 (DE-599)BVBBV016542896 |
| dewey-full | 362.17/82 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 362 - Social problems and services to groups |
| dewey-raw | 362.17/82 |
| dewey-search | 362.17/82 |
| dewey-sort | 3362.17 282 |
| dewey-tens | 360 - Social problems and services; associations |
| discipline | Soziologie Wirtschaftswissenschaften |
| format | Book |
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| id | DE-604.BV016542896 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-09T19:11:45Z |
| institution | BVB |
| isbn | 9241562064 |
| language | English |
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| physical | IX, 142, 47 S. graph Darst. |
| publishDate | 2002 |
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| publisher | World Health Organization |
| record_format | marc |
| spelling | Ratanawijitrasin, Sauwakon Verfasser aut Effective drug regulation a multicountry study by Sauwakon Ratanawijitrasin ; Eshetu Wondemagegnehu Geneva World Health Organization 2002 IX, 142, 47 S. graph Darst. txt rdacontent n rdamedia nc rdacarrier Drugsgebruik gtt Drugshandel gtt Médicaments - Droit Médicaments - Politique gouvernementale Regulering gtt Recht Drugs Law and legislation International cooperation Pharmaceutical policy International cooperation Internationaler Vergleich (DE-588)4120509-1 gnd rswk-swf Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf Arzneimittelsicherheit (DE-588)4143182-0 s Internationaler Vergleich (DE-588)4120509-1 s DE-604 Arzneimittelprüfung (DE-588)4128030-1 s Wondemagegnehu, Eshetu Verfasser aut HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010222484&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Ratanawijitrasin, Sauwakon Wondemagegnehu, Eshetu Effective drug regulation a multicountry study Drugsgebruik gtt Drugshandel gtt Médicaments - Droit Médicaments - Politique gouvernementale Regulering gtt Recht Drugs Law and legislation International cooperation Pharmaceutical policy International cooperation Internationaler Vergleich (DE-588)4120509-1 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| subject_GND | (DE-588)4120509-1 (DE-588)4128030-1 (DE-588)4143182-0 |
| title | Effective drug regulation a multicountry study |
| title_auth | Effective drug regulation a multicountry study |
| title_exact_search | Effective drug regulation a multicountry study |
| title_full | Effective drug regulation a multicountry study by Sauwakon Ratanawijitrasin ; Eshetu Wondemagegnehu |
| title_fullStr | Effective drug regulation a multicountry study by Sauwakon Ratanawijitrasin ; Eshetu Wondemagegnehu |
| title_full_unstemmed | Effective drug regulation a multicountry study by Sauwakon Ratanawijitrasin ; Eshetu Wondemagegnehu |
| title_short | Effective drug regulation |
| title_sort | effective drug regulation a multicountry study |
| title_sub | a multicountry study |
| topic | Drugsgebruik gtt Drugshandel gtt Médicaments - Droit Médicaments - Politique gouvernementale Regulering gtt Recht Drugs Law and legislation International cooperation Pharmaceutical policy International cooperation Internationaler Vergleich (DE-588)4120509-1 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| topic_facet | Drugsgebruik Drugshandel Médicaments - Droit Médicaments - Politique gouvernementale Regulering Recht Drugs Law and legislation International cooperation Pharmaceutical policy International cooperation Internationaler Vergleich Arzneimittelprüfung Arzneimittelsicherheit |
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