Global and Regional Drug Regulatory Harmonization Initiatives

The diversity of pharmaceutical regulatory requirements makes marketing new drugs a very complex and costly process that delays public access to innovative and essential drugs. In recent years, the pharmaceutical industry has become increasingly multinational, taking advantage of the growing opportunities in the rapidly expanding new markets in Asia, Latin America, the Middle East, and Africa. This globalization trend created the need for a new strategic approach to pharmaceutical regulations, leading to more international cooperation and harmonization. Globalization of pharmaceutical regulatory standards has become a necessity and a goal for many groups of neighboring countries in several regions of the world to reduce unnecessary and duplicative requirements, rationalize time and costs, and create a transparent regulatory process that improves access to medicines. Regional harmonization is characterized by a number of initiatives driven mainly by common economical and social needs and supported by global organizations such as WHO and ICH. This article provides an introduction to the major global and regional drug regulatory harmonization initiatives. These initiatives are at different stages of development and maturity, those including the more established countries being at more advanced stages than the less-resourced ones.