Equivalência farmacêutica : proposta de manual para a implantação e a padronização de centros em conformidade com as normas técnicas e a legislação sanitária vigentes

Abstract

In 1999, the policy of generic medicaments was implemented in Brazil, and the availability of pharmaceutical equivalence essays became strategic for its success. A group of laboratories was identified, evaluated and qualified, as a network, by the National Sanitary Surveillance Agency (Anvisa) to perform such studies. These laboratories were named ‘centers for pharmaceutical equivalence’ (EQFAR), and were integrated to The Brazilian Network of Analytical Laboratories on Health (REBLAS). The criteria for qualification and operation of the centers, as well as to perform standardized pharmaceutical equivalence essays, were established by a set of regulations (laws, resolutions and technical rules). The extent, diversity and complexity of these regulations do not always facilitate its knowledge, comprehensive and correct application for people interested in implementation of those rules on the centers as well as the National Sanitary Surveillance Agency tasks of evaluation, qualification and audition. This material consolidate the content of the regulation in force, systematizing them according the following chapters: referential documentation, human resources, biosafety and laboratorial organization, facilities and installations, quality assurance, equipment, materials, and the principals essays that compose the studies of pharmaceutical equivalence and the preparation of their analytical certification. It aims to be a practical instruction – like a manual – that allows the rapid access to the weighty information and to facilitate the work of people interested in implement a center of pharmaceutical equivalence and for those from the Sanitary Surveillance Agencies.