Abstract

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together pharmaceutical regulators from the United States, Europe, and Japan, along with pharmaceutical trade associations from these regions. The goal of the ICH is to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration, thereby reducing duplication of testing and reporting carried out during the research and development of new medicines. Steps have been defined to accomplish this goal in four areas of pharmaceutical regulations (efficacy, safety, quality, and multidisciplinary).

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