Washington, D.C., (PAHO/WHO), July 2017. The Medicines Regulatory Authorities in the region, with the support of the Pan American Health Organization/World Health Organization (PAHO/WHO), are developing a project to align efforts and enhance benefits in the joint evaluation of periodic safety update reports (PSURs).

joint-evaluation-jul2017The PSURs are technical documents that contain a summary of up-to-date global information about a medicine's safety -prepared by the marketing authorization holder-which aim to group evidence about the benefit-risk assessment of a specific product over time. These reports are periodic and allow national regulatory authorities to be updated on new reported adverse events, safety situations, changes in use and other important pharmacological aspects.

In many cases, the PSUR are similar between countries. For this reason, the collaborative evaluation initiative seeks to strengthen synergies and avoid duplication of activities by countries, especially considering that these are usually very large documents.

In a pilot phase, the National Pharmacovigilance Centers of the National Regulatory Agencies of Brazil (known in Portuguese as ANVISA) and Chile (known in Spanish as ISP) conducted a joint evaluation of a PSUR, with the expert coordination of Health Canada and with PAHO/WHO support, resulting in an evaluation report that includes conclusions and recommendations of each of the countries in an abbreviated and consolidated form. This report is available for the Authorities through the Regional Platform on Access and Innovation for Health Technologies (PRAIS).

Currently, in the framework of this initiative, Cuba and Peru are conducting a second joint evaluation, and Brazil and Chile a third one. The project results will be discussed at the Global Meeting of Pharmacovigilance in the Americas, to be held in Bogota, Colombia, from August 22 to 25, 2017. This initiative also seeks to generate and multiply capacities in order to have in place, in a two-year period, a diligent, cooperative and shared assessment of these reports.

Links of interest


Medicines and Health Technology Unit

Health Systems and Services

Pan American Health Organization

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