Pharmaceutical Drug Product Registration and Requirements in Latin American Countries

Abstract

The regulatory process to obtain marketing authorization’s (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. This article offers a practical overview of product registration processes in LATAM. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory and highly country-specific documentation (related to infrastructure, legal documents, stability studies, labelling, etc.) require strategic planning and allocation for successful and timely local approvals. Exhaustive identification of actual requirements can present challenges due to frequent changes in regulations, unclear expectations, etc. Having as much early visibility and command of the LATAM country-specific requirements and health authorities’ (HAs) expectations will help the pharmaceutical industry to improve planning for global MA applications, optimally manage internal expectations, and most importantly give patients in the region faster access to therapies and better quality of life.

Keywords: Latin America (LATAM),  Common Technical Document (CTD),  Certificate of Pharmaceutical Product (CPP), Certificate of Medicinal Product (CMP), Chemistry, manufacturing and controls (CMC)