Resumo

VASQUEZ, Hans; SALAS, Sofía; FIGUEROA, Linder  e  GUTIERREZ, Sonia. Efficacy and safety in the new regulation of pharmaceutical products in Peru. Rev. perú. med. exp. salud publica [online]. 2012, vol.29, n.4, pp.545-548. ISSN 1726-4634.

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.

Palavras-chave : Drug evaluation; Legislation, drug; Drugs, essential.

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