ABSTRACT
The International Conference on Harmonization (ICH) has set itself the laudable goal to harmonize the technical requirements for the approval of medicinal products in the three most prosperous regions of the world: the United States, Japan, and the European Union (EU). Towards this goal, it has published many guidelines, covering such topics as carcinogenicity testing, good clinical practices, stability testing, impurity testing, etc. This author had the unique and exciting opportunity to be involved in the development of the Common
Technical Document-Quality (CTD-Q) that is part of one such guideline, the Common Technical Document (CTD). As a member of the CTD-Q Expert Working Group (EWG), this author had the opportunity to learn from fellow EWG members the regulatory processes in Japan, Canada, and the EU. The ICH employs a unique process to manage the development and publication of these guidelines that affords intense discussions/ negotiations between the various parties, but is efficient in producing the guidelines in a timely fashion. In this article the author has attempted to provide his perspective of the CTD-Q based on his experiences as a CTD-Q EWG member and Chemistry Reviewer in the Office of Generic Drugs. This article was written by the author in his private capacity. No official support or endorsement by the Food and Drug Administration (FDA) is intended or should be inferred. The information provided here is also based on many guidances that are published or unpublished draft guidances. The reader should exercise caution in using draft guidances when preparing submissions to FDA as the content of these draft guidances may change before final publication.
