Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú

Hans Vásquez; Sofía Salas; Linder Figueroa; Sonia Gutiérrez

doi:10.17843/rpmesp.2012.294.402

Authors

Hans Vásquez Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Ministerio de Salud. Lima, Perú. Médico cirujano especialista en Salud Pública con mención en Epidemiología.
Sofía Salas Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Ministerio de Salud. Lima, Perú. químico farmacéutico.
Linder Figueroa Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Ministerio de Salud. Lima, Perú. Unidad de Posgrado de Farmacia y Bioquímica, Universidad Nacional Mayor de San Marcos. Lima, Perú. químico farmacéutico magister en Farmacia Clínica.
Sonia Gutiérrez Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Ministerio de Salud. Lima, Perú. químico farmacéutico.

DOI:

https://doi.org/10.17843/rpmesp.2012.294.402

Keywords:

Drug evaluation, Legislation, drug, Drugs, essential

Abstract

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.