附註:"This report is a synthesis of the results of the multicountry studies carried out by the WHO Essential Drugs and Medicines Policy Unit (EDM)"--Page ix.
Includes bibliographical references (pages 138-139).
1. DRUG REGULATION: OBJECTIVES AND ISSUES; 2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION; 3. PROFILE OF THE COUNTRIES; 4. REGULATORY FRAMEWORK; 5. REGULATORY CAPACITY; 6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE; 7. INSPECTION AND SURVEILLANCE; 8. PRODUCT ASSESSMENT AND REGISTRATION; 9. CONTROL OF DRUG PROMOTION AND ADVERTISING; 10. DRUG QUALITY CONTROL LABORATORY; 11. ASSESSING REGULATORY PERFORMANCE; 12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION.
摘要: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 through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia.
