ANMAT: First National Drug Regulatory Agency designated as Reference Authority by PAHO

In the framework of a Pan American Health Organization (PAHO) initiative to promote the recognition of Drug Regulatory Authorities, ANMAT´s evaluation process finished on December 11, 2009. PAHO fosters this WHO initiative in the Americas by carrying out evaluation processes led by experts. Countries submit themselves to the evaluation processes voluntarily. After exhaustive consultation and approval procedures, all the Americas countries agreed upon the election of an evaluation tool comprising all the regulatory functions an Authority should perform and the indicators proving its compliance. The first Drug Regulatory Authorities (DRA) that applied for an evaluation were: Chile´s ISP, Colombia´s INVIMA, Cuba´s CECMED and Argentina´s ANMAT. The evaluation performed on ANMAT was rated with a level IV certification, which is the maximum rating granted and which makes it the first National Reference Authority in Drugs Regulation in the region. The PAHO evaluating team was made up of José Peña Ruz (Team leader/ PAHO), Elvira Marchan (Ecuador), Eduardo Johnson (Chile), Liana Figueras (Cuba), Jorge Olarte (Colombia), María Teresa Cuesta (Spain), Carmen Becerril (Mexico) and María Teresa Ibarz (Venezuela). The audit focused on ten modules containing the standards set by the Pan American Health Organization (PAHO):

- National Drug Regulatory Agency: its organization and legal foundations. - The national regulatory system: organizational structure, institutional development and quality management. - Sanitary register: outlines, guidelines, procedures, evaluation mechanisms, registers and information availability. - Market vigilance: import and export controls, recall procedures. - Pharmacovigilance: outlines and guidelines, organization and structure, evaluation procedures. - Control of clinical trials: guidelines, ethical framework, organization and structure, evaluation procedures. - Regulating inspections and monitoring activities: guidelines, outlines, planning, registers. - National quality control laboratory: organization, structure, quality management, human resources, equipment and safety structure.

This evaluation process and resulting recognition of ANMAT as a PAHO Reference DRA was a powerful incentive for the whole agency that held a demanding activity schedule for several months. In the light of the above mentioned, the professional, technical and administrative staff committed deeply to the objective in the knowledge that the achievement of this result would mean a significant award for our country. The working teams showed an excellent technical and professional performance then reflected in the final qualification obtained.

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