Resumen

SANCHEZ GONZALEZ, Celeste Aurora  y  ORTA HERNANDEZ, Santa Deybis. Normas farmacológicas cubanas: desarrollo e impacto. Rev Cubana Farm [online]. 2003, vol.37, n.2. ISSN 0034-7515.

The importance as a consultation tool of the National Compendium of active ingredients for industrial pharmaceutical use and its combinations that are accepted and refused in Cuba was described. The safety information for their rational use that includes the adopted therapeutic classification and the organizational structuring of the Cuban Pharmacological Standards were identified. Its application was quantified by the Center for Drug Quality Control (CECMED) , by national and foreign users in the period 1996-2000, in order to identify the degree of novelty of products and the therapeutical characterization by analysing the authorised clinical trials and the register of provided drugs. The impact on the National Pharmaceutical Regulation, and the interrelation with other regulations were shown. The scope and contents of the development prospects were stated. It was concluded that Cuban Pharmacological Standards are useful for the correct classification of the degree of novelty of products, the precise and quick management and assessment of the procedures and their therapeutical characterisation.

Palabras clave : PHARMACOLOGY [standars]; PHARMACEUTICAL PREPARATIONS; LEGISLATION; DRUGS; CUBA.