Requirements for Medicines Registration in the Americas, 2013.

This document comprises the requirements for the initial registration of medicines (marketing authorization) in the Americas, prepared by the Working Group on Medicines Registration of the Pan American Network on Drug Regulatory Harmonization (PANDRH). Its purpose is to provide requirements for establishing regulations and regulatory tools that will contribute to the harmonization process of medicines registration to ensuring the efficacy, quality and safety of medicines to be available in the countries of our Region.