Review of regulation of biological and biotechnological products in Latin American and Caribbean countries.

The regulation of the biological and biotechnological products constitutes a significant challenge, since they are part of a sector of the pharmaceutical industry that is currently experiencing rapid growth. Unlike conventional medicines, the manufacture of these products involves the use of living organisms and processes that impede manufacturing consistency. Even though there are numerous international reference documents related to biotechnological product regulation, there is no consensus by official entities that are considered reference institutions, with regard to the most important definitions used and the mechanisms for product regulation. The Pan-American Health Organization (PAHO), through the Technology, Health Care and Research Area, has developed a series of activities that are described in this document. The objective of this publication is to present the current picture of biotechnological and biological product regulation in the Latin American and Caribbean Region, in order to offer guidance that will facilitate the regulation of these products in a harmonized manner among the countries of the Member States, as well as responding to the request from some regulatory agencies to address the growing demand for licensing applications of these products.