Difference between revisions of "International Conference on Harmonisation"
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Revision as of 18:01, 29 September 2008
This is a Glossary page
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
Definition
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.
The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.
Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.
The ICH is the body that created the guidance for the eCTD, and Clinical Study Report standards, among many others that are of concern to Sponsors also involved in Regulated Product Submissions.
