- Mots-clés > drug registration
- Mots-clés > harmonization of medicines regulation
- Mots-clés > marketing authorization
- Mots-clés > medicines registration
- Mots-clés > medicines regulatory systems
- Mots-clés > pharmaceutical legislation
- Mots-clés > pharmaceutical regulation
- Mots-clés > registration
- Mots-clés > registration of pharmaceuticals
(2013; 42 pages) [Spanish]
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.
National standards shall be established in keeping with each country’s legislation, and whenever pertinent, appropriate changes will be made in order to adhere as much as possible to these requirements.
The information must be presented in the language of the country where the medicines are being registered...