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Effective Drug Regulation : a Multicountry Study.
Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control t...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Albany :
World Health Organization,
2002.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 1. DRUG REGULATION: OBJECTIVES AND ISSUES; 1.1 Drugs as an instrument of public health; 1.2 Controlling private behaviour for public purposes; 1.3 Objectives and organization of this report; 2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION ; 2.1 Project rational and development; 2.2 Study objectives; 2.3 Method of study; 2.4 Drug regulation from a comparative perspective; 3. PROFILE OF THE COUNTRIES; 3.1 General background; 3.2 Political environment; 3.3 Pharmaceutical sector environment; 4. REGULATORY FRAMEWORK; 4.1 Missions and goals of drug regulation; 4.2 Domains of control.
- 4.3 Other non-regulatory pharmaceutical functions4.4 National drug policy; 4.5 Historical development of drug regulation; 5. REGULATORY CAPACITY; 5.1 Legal basis, organizational structure and authority; 5.2 Human resources; 5.3 Financing drug regulation; 5.4 Planning, monitoring and evaluating implementation; 5.5 Problems encountered and strengths identified; 5.6 Political influence and accountability; 6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE; 6.1 Power and process; 6.2 Human resources; 6.3 Paying for licensing; 6.4 Performance; 7. INSPECTION AND SURVEILLANCE.
- 7.1 Power and process: comparing structures and processes7.2 Human resources; 7.3 Paying for inspection; 7.4 Planning, process and performance; 8. PRODUCT ASSESSMENT AND REGISTRATION; 8.1 Power and process; 8.2 Human resources; 8.3 Paying for registration; 8.4 Performance; 8.5 Adverse drug reaction monitoring; 8.6 Clinical trials; 9. CONTROL OF DRUG PROMOTION AND ADVERTISING; 9.1 Power and process: comparing structures and processes; 9.2 Performance; 10. DRUG QUALITY CONTROL LABORATORY; 10.1 Power and process; 10.2 Human resources; 10.3 Paying for quality control; 10.4 Performance.
- 11. ASSESSING REGULATORY PERFORMANCE11.1 Assessing government functions: an essential part of policy-making; 11.2 Monitoring and evaluation system; 11.3 Monitoring and evaluating the effectiveness of drug regulation; 11.4 Monitoring and evaluating the efficiency of drug regulation; 11.5 Monitoring and evaluating the accountability and transparency of drug regulation; 11.6 Availability of information for assessment; 12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION; 12.1 Conclusions related to regulatory structures; 12.2 Conclusions related to regulatory processes.