Resumen

SANCHEZ GONZALEZ, Celeste Aurora. Regulating results attained in Cuba by using the WHO's quality certification scheme. Rev Cubana Farm [online]. 2008, vol.42, n.2. ISSN 0034-7515.

An analysis of the objectives and importance of WHO's quality certification scheme for the pharmaceuticals object of international trade and of the adequate conditions of drug regulations in Cuba was made for its implementation as regards the registry system and the inspections to check the fulfilment of good practices of manufacture and access to laboratories for the analysis of samples. The measures taken for its implementation and the satisfactory results attained are mentioned, among which the development of the summary of the characteristics of the product as a synthesis of the approved conditions of a drug with its register and document of public information that is annexed to one of the scheme certificates stand out. It is concluded that the application of the scheme by the Centre for Drug Quality Control for the import and export of drugs has allowed to achieve a higher level in the regulating and control actions and in the rigor of the evaluation of import products, a better level of transparency and of regulating culture and an increase of the confidence in the Cuban products that are exported and in their quality warranty.

Palabras clave : Certification scheme; drug quality control.