A REVIEW OF DOCUMENTATION REQUIREMENTS FOR PRECLINICAL SECTIONS, FOR MARKETING SUBMISSIONS IN THE EUROPEAN-COMMUNITY, JAPAN AND THE USA

Standardization of the documentation requirements for preclinical sect ions, for marketing submissions in the European Community (EC), Japan and the USA is proposed. It is unnecessary to standardize the leading summaries of submissions as their format is predicated by the way in w hich the regulatory authorities review applications. Harmonization of the technical sections will reduce the duplication of effort expended by pharmaceutical companies to produce documentation specific for each regulatory authority. Elimination of requirements specific to individ ual authorities will further reduce the resource requirements. The pro posals made in this paper are aimed to increase the 'user-friendliness ' of the preclinical documentation and therefore expedite the review p rocess.