The Format and Content of a Global Chemical/Pharmaceutical Documentation — A Proposal *

Abstract

A DIA workshop was held in Noordwijk, The Netherlands on October 24-25, 1994 on the subject of managing the global chemical/pharmaceutical documentation. Speakers and chairpersons were drawn from both the major regulatory authorities and the pharmaceutical industry. The objective of the workshop was to review the content and the format of the chemical/pharmaceutical documentation (CMC section) of the dossier filed in support of an application for a marketing authorization in Europe, the United States, Canada, Australia, or Japan. The aim of the workshop was to provide an overview of how to develop and maintain an international core dossier that the authorities find user friendly.

The proposal which follows divides the CMC file into two major sections: drug substance and drug product. Each major section of the CMC file is divided into two parts: regulatory (manufacturing and control) and scientific. This division would enable the file to be split after approval to provide an official regulatory file which could be used as a reference document for evaluation of subsequent applications for variations, as afile of methods for testing samples by official control laboratories, and to facilitate good manufacturing practice (GMP) inspections.