Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
(2002; 187 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoACRONYMS
Ver el documentoPREFACE
Ver el documentoACKNOWLEDGEMENTS
Ver el documentoEXECUTIVE SUMMARY
Abrir esta carpeta y ver su contenido1. DRUG REGULATION: OBJECTIVES AND ISSUES
Abrir esta carpeta y ver su contenido2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION
Abrir esta carpeta y ver su contenido3. PROFILE OF THE COUNTRIES
Cerrar esta carpeta4. REGULATORY FRAMEWORK
Ver el documento4.1 MISSIONS AND GOALS OF DRUG REGULATION
Ver el documento4.2 DOMAINS OF CONTROL
Ver el documento4.3 OTHER NON-REGULATORY PHARMACEUTICAL FUNCTIONS
Ver el documento4.4 NATIONAL DRUG POLICY
Ver el documento4.5 HISTORICAL DEVELOPMENT OF DRUG REGULATION
Abrir esta carpeta y ver su contenido5. REGULATORY CAPACITY
Abrir esta carpeta y ver su contenido6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE
Abrir esta carpeta y ver su contenido7. INSPECTION AND SURVEILLANCE
Abrir esta carpeta y ver su contenido8. PRODUCT ASSESSMENT AND REGISTRATION
Abrir esta carpeta y ver su contenido9. CONTROL OF DRUG PROMOTION AND ADVERTISING
Abrir esta carpeta y ver su contenido10. DRUG QUALITY CONTROL LABORATORY
Abrir esta carpeta y ver su contenido11. ASSESSING REGULATORY PERFORMANCE
Abrir esta carpeta y ver su contenido12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
Abrir esta carpeta y ver su contenidoANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE
 

4.3 OTHER NON-REGULATORY PHARMACEUTICAL FUNCTIONS

Some governments not only regulate, but also manufacture, purchase and distribute drugs.

Cuba, Cyprus, Tunisia and Venezuela have government pharmaceutical manufacturing facilities operating as public enterprises. Cuba has over 50 pharmaceutical manufacturing facilities throughout the country. In Cyprus, the Pharmaceutical Laboratory has a manufacturing unit that is responsible for producing and repacking drugs for use in public hospitals and pharmacies. As stated above, products manufactured by the Laboratory do not need to be registered. The Ugandan Government undertakes manufacturing through its sole pharmaceutical public enterprise-the National Enterprises Corporation. Tunisia, by contrast, has a number of public enterprises that manufacture pharmaceuticals. In Venezuela, too, various Government organizations are responsible for producing various types of products for the health service.

The Australian and Malaysian governments currently do not undertake pharmaceutical manufacturing. Formerly, the Australian Government owned the Commonwealth Serum Laboratories, but it privatized this operation in the early 1990s. Similarly, the Malaysian Government ended its role in pharmaceutical manufacturing in 1993. In view of the trend towards privatization of public enterprise, more governments can be expected to follow the examples of Australia and Malaysia.

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Última actualización: le 3 mayo 2013