Abstract

THE STATUS QUO OF REGULATORY PROCESS IN LATAM COUNTRIES: A REVIEW.

J. Balasubramanian*, K. Saisugathri, G. Sai Prasanna Lakshmi, G. Adhinarayana,
G. A. Nandhini

ABSTRACT

The regulatory process to obtain marketing authorisations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonisation efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or show-stoppers to local product launches. This article offers a practical overview of product registration processes in LATAM, resulting from more than a decade of experience in a biotech company, to ensure successful global regulatory strategy. Although the International Conference on Harmonisation (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. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market.

Keywords: LATAM, CTD, ICH, MA.