Medicines and the New Economic Environment
(1998; 252 pages) [Spanish]
Índice de contenido
Ver el documentoTHE AUTHORS
Ver el documentoPREFACE
Ver el documentoINTRODUCTION
Abrir esta carpeta y ver su contenidoI. THE GLOBAL ECONOMIC ENVIRONMENT
Cerrar esta carpetaII. THE REFORM OF HEALTH CARE SYSTEMS
Abrir esta carpeta y ver su contenidoII. 1. Cost Containment and Health care Reforms: the Impact on Pharmaceuticals
Abrir esta carpeta y ver su contenidoII.2. Reform of Health Care Services in Developing Countries, Role of the State and Essential Drugs
Cerrar esta carpetaII.3. Regulation, Policies and Essential Drugs
Abrir esta carpeta y ver su contenido1. TWO MAJOR TRENDS
Cerrar esta carpeta2. DRUGS
Abrir esta carpeta y ver su contenido2.1. The process of innovation
Cerrar esta carpeta2.2. The selection process
Ver el documento2.2.1. Prevailing health criteria
Ver el documento2.2.2. Regulatory approval: selecting the useful and safe
Ver el documento2.2.3. Essential drugs: the best
Ver el documento2.2.4. And what about quality?
Abrir esta carpeta y ver su contenido2.3. The expansion of markets
Abrir esta carpeta y ver su contenido2.4. The creation of common areas: harmonization
Abrir esta carpeta y ver su contenido2.5. Ongoing processes
Ver el documento3. CONCLUSIONS
Abrir esta carpeta y ver su contenidoIII. A CHANGING PHARMACEUTICAL INDUSTRY
Abrir esta carpeta y ver su contenidoIV. SYNTHESIS AND FORECASTS
Ver el documentoBIBLIOTECA CIVITAS ECONOMÍA Y EMPRESA
Ver el documentoBACK COVER
 
2.2.4. And what about quality?

The preceding issues refer to the pharmacological-type notions that encourage State intervention. But there are some strictly pharmaceutical aspects that also generate areas where State intervention is essential: a product may be surrounded by the best pharmacological properties (effectiveness, safety, etc.), but if the product's manufacturing process does not have all the required guarantees, its use could be lethal.

For a long time our countries have directed their efforts towards the control of the finished product. A modern concept of quality assurance is clearly oriented to the building of quality and not to its «control» in the final product, so that the emphasis is put on Good Manufacturing Practices guidelines.

Once again, the State exerts its authority to create a situation that includes quality assurance: the production process is regulated in such a way that all the probabilities aim towards a totally reliable final product. This is the best protection the State can offer to the country's population. Sample testing is only intended to serve as an instrument to validate something that is supposed to be controlled «at source».

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Última actualización: le 3 mayo 2013