Abstract
Back in the beginning of the 1990s the International Conference on Harmonization (ICH) was born with the objective of achieving greater harmonization of technical requirements for medicinal products, through an active process of discussion, debate, and review of science by international experts of the highest caliber. More than 10 years later, this article will review some of the achievements and missed opportunities of ICH in the process of harmonizing requirements and, in turn, harmonizing the way we develop medicinal products to support quality, safety, and efficacy from a regulatory viewpoint. This article will also look at new initiatives recently discussed at ICH such as M5, the Common Technical Document (CTD), and M2, the guideline that deals with the standards required for electronic transfer of regulatory information to regulatory authorities and how this will effect the way we move the technical reports into regulatory submissions and the subsequent review of these by the regulatory authorities in the future.
Published Version
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