The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was a consultation exercise undertaken by the regulatory authorities of Europe (European Medicines Evaluation Agency [EMEA]), the US (Food and Drug Agency [FDA]) and Japan (Ministry of Health and Welfare , Tokyo) and representatives of the pharmaceutical industry, to discuss the requirements for drug evaluation and registration and to file guidelines. The Tripartite Guidelines is a system of guidelines that are legally binding in all three areas. Due to the fact that these regions represent an overwhelming share of the pharmaceutical world and that many other countries use either home certificates (pharmaceutical products that are registered in their country of manufacture do not need registration/authorization after import) or accept documentation according to the Tripartite Guidelines for their own registration process, these Tripartite...