Good Clinical Practices (GCP) in Latin America: Prospects for Regional Harmonization: A Challenge for the Twenty-First Century

Abstract

This position paper reviews the situation and prospects for the implementation of Good Clinical Practices (GCP) regulations in Latin America. Opportunities and challenges for clinical drug development are evaluated with particular emphasis on the existing technical and political barriers. Lack of harmonization of GCP regulations, processes, procedures, and related issues across countries and between agencies within some countries hamper the progress of overall regionalization, resulting in underdevelopment of clinical research. Moreover, there is a general consensus that shortage of knowledgeable regulators, investigators, GCP training programs, and scarcity of experienced professionals in clinical drug development continue to impair progress and prevent the region from reaching its full potential. Solutions to increase the implementation of the International Conference on Harmonization (ICH) GCP standards are suggested with emphasis on training and effecting technical cooperation between the pharmaceutical industry, academic institutions, and health authorities. Implementation and regional harmonization of ICH GCP regulations become more important as the entire Latin American region evolves as part of a globalized world and enters the twenty-first century with scientific and technical ambitions of becoming an effective partner in the drug development area. This harmonization process should be supported by and undertaken under the umbrella of the Pan American Health Organization (PAHO) which has the responsibility to foster initiatives to enhance economic and health care activities, in particular when these initiatives are based on internationally harmonized principles and standards.