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evaluacion-arn-els-2017

Washington, DC., (PAHO/WHO)- On 24-28 July 2017, the Pan American Health Organization (PAHO) evaluated the regulatory capabilities of the National Regulatory Authority for Medicines and Biologicals (vaccines) in El Salvador, through an examination of the performance of its essential functions as a regulation and enforcement agency.

This initiative is part of PAHO's 2010 Resolution "Strengthening National Regulatory Authorities for Medicines and Biological" (CD50.R9), which urged Member States to evaluate the performance of National Regulatory Authorities (NRAs) in their regulation and enforcement functions.

The process of evaluation and qualification of NRAs is based on compliance with critical indicators recommended by the World Health Organization for the strengthening of Regulatory Bodies.

In El Salvador, the following functions were qualified: national regulatory system; marketing authorization; licensing activities;  postmarketing surveillance and control, import and export controls; pharmacovigilance; clinical trials; regulatory inspections and control activities; official medicines control laboratory, and release of batches of biologicals (vaccines).

The results show a significant advance in medicine regulation, not only at the national level, but also at the sub-regional level. Likewise, it was possible to implement an innovative model of regulation in which communication plays a decisive role in both taking action and facing the society.

The regulatory authority in El Salvador is the first country, in the Central American subregion, which has been subjected to this exhaustive exercise, in order to identify strengths, opportunities for continuous improvement, and recommendations for subsequent actions.

The evaluation process is carried out by peers. In El Salvador's evaluation process participated experts from the national regulatory authorities of Brazil, Canada, Chile, Colombia, Cuba, and Uruguay, jointly with PAHO representatives.

Related links

System for Evaluation of the National Regulatory Authorities for Medicines

Strengthening National Regulatory Authorities for Medicines and Biologicals. CD50.R9, 2010.