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

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.

Effect of free trade agreements on pharmaceutical market competition: The case of the 2009 US-Peru free trade agreement and its implementation as national drug policy

“…In the 1990s, the Peruvian pharmaceutical sector underwent profound changes, from being a highly regulated market, with price controls and multiple barriers to entry, to a less regulated market, with prices set by the pharmaceutical companies [2] , [3] . The General Health Law 26842 enacted in 1997 [4] stated that the registration of drugs was possible with the simple presentation of an affidavit about the quality of the product and the enclosure of a free sale certificate issued by the health authority from where the product was imported; and the procedure lasted only seven days [6] , [5] . Thus, a large number of products were registered during the period 1990–2008 [2] .…”