[Contribution of Peru in initiatives to promote global health security]. / Contribución del Perú en las iniciativas para promover la seguridad sanitaria mundial.

This article describes the concept of global health security and its development over time. It emphasizes the need to control challenges against global health such as those produced by biologic agents both natural and intentional. It presents world initiatives that have developed during the last two decades and the contribution of Peru to the Global Health Security Agenda (GHSA) and the Monitoring and Evaluation Framework. In order to accelerate the implementation of the International Health Regulations Peru has played an important role to accelerate the implementation of International Health Regulations (IHR), participating with a group of countries, World Health Organization (WHO), and GHSA in the creation of the Joint External Evaluation Tool (JEE).

[Efficacy and safety in the new regulation of pharmaceutical products in Peru]. / Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú

Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category.